Breast Cancer Treatment

Breast cancer treatment includes treatment of the breast and treatment for cancer cells that may have spread to other parts of the body. The breast itself is treated by surgery, often in combination with radiation. The lymph nodes in the armpit are also studied to see if the breast cancer has spread. The treatment for cancer cells that may have spread beyond the breast and lymph nodes in the armpit is a combination of either hormone therapy and/or chemotherapy.

Surgery

Most women with breast cancer will have surgery. The 2 common types of surgery are breast-conserving surgery and mastectomy.

Breast Conserving Surgery

Lumpectomy removes only the breast lump and a rim of normal surrounding breast tissue. Partial or segmental mastectomy or quadrantectomy removes more breast tissue than a lumpectomy (up to one-quarter of the breast). If cancer cells are present at the outside edge of the removed breast tissue (the margin), more surgery is usually needed to remove any remaining cancer. Most often this additional surgery is a repeat lumpectomy, but sometimes it requires removal of the entire breast (mastectomy).

Radiation therapy is usually given after these types of surgery. Side effects of these operations include temporary swelling and tenderness and hardness due to scar tissue that may form in the surgical site.

For most women with stage I or II breast cancer, breast-conserving therapy (lumpectomy and radiation therapy) is as effective as mastectomy. Survival rates of women treated with these 2 approaches are the same. However, breast conservation therapy is not an option for all women with breast cancer. (See the discussion, “Choosing Between Breast-Conserving Therapy and Mastectomy”.) Those who may not have breast-conserving therapy include:

• Women with suspicious abnormalities that appear to be cancerous and are widespread throughout the breast
• Women whose lumpectomy, including any possible repeat lumpectomy when needed, cannot completely remove their cancer with a satisfactory cosmetic result
• Pregnant women who would require radiation while still pregnant

There are other groups of women for whom breast-conserving therapy is not strictly ruled out, but for whom the risks associated with this treatment are higher. (For example, they may have an increased likelihood of experiencing recurrent breast cancer or side effects from radiation.) These groups include:

• Women with active connective tissue disease involving the skin (especially scleroderma and lupus)
• Women with tumors greater than 5 cm
• Women who after lumpectomy have a very limited amount of cancer at the edge of the pathology specimen
• Women who are 35 years of age or less
• Women who have not yet gone through menopause and have a known BRCA1 or BRCA2 gene mutation.

The last 2 groups of women have a higher risk of breast cancer recurring in the breast in which the cancer was originally found and also in the opposite breast when compared to older women and women without gene mutations associated with breast cancer. For this reason, these women may consider the option of surgical removal of both breasts (double mastectomy) to decrease their future risk of breast cancer.

Radiation therapy as a part of breast-conserving therapy for invasive cancer can sometimes be omitted. Women who may consider lumpectomy without radiation therapy have all of the following:

• age 70 years or older; and
• a tumor 2 cm or less that has been completely removed; and
• a tumor that contains hormone receptors; and
• no lymph node involvement; and
• who receive treatment with hormone therapy

Mastectomy

Mastectomy is removal of the entire breast, including the nipple. Mastectomy is needed for some cases, and some women choose mastectomy rather than lumpectomy. (See the discussion ”Choosing Between Breast-Conserving Therapy and Mastectomy” immediately below.)

Different words are used to describe mastectomy depending on the extent of the surgery done in the armpit and the muscles under the breast. In a simple or total mastectomy the entire breast is removed, but no lymph nodes from under the arm or muscle tissue from beneath the breast is removed. In a modified radical mastectomy, the entire breast and some axillary (underarm) lymph nodes are removed. In a radical mastectomy, all the muscle under the breast is also removed. Radical mastectomy is rarely used today because for most women, this surgery is not any more effective than the more limited forms of mastectomy.

Choosing Between Breast-Conserving Surgery and Mastectomy

The advantage of breast-conserving surgery (lumpectomy) is that it preserves the appearance of the breast. A disadvantage is the need for several weeks of radiation therapy after surgery. However, some women who have a mastectomy will also need radiation therapy. Women who choose lumpectomy and radiation can expect the same chance of survival as those who choose mastectomy.

Although most women and their doctors prefer lumpectomy and radiation therapy, your choice will depend on a number of factors, such as:

• how you feel about losing your breast
• whether you want to devote the additional time and travel for radiation therapy
• whether you would want to have more surgery to reconstruct your breast after having a mastectomy
• your preference for mastectomy as a way to “take it all out as quickly as possible”

In determining your preference for lumpectomy or mastectomy, be sure to get all the facts. Though you may have a gut feeling for mastectomy to “take it all out as quickly as possible,” the fact is that doing so does not provide any better chance of long term control or a better outcome of treatment in most cases. Large research studies with thousands of women participating, and over 20 years of information show that when lumpectomy can be done, mastectomy does not provide any better chance of survival from breast cancer than lumpectomy plus radiation. It is because of these facts that most women today do not have their breast removed.

Reconstructive Surgery

If a woman has a mastectomy, she may want to consider having the breast rebuilt; this is called breast reconstruction) This requires additional surgery to create the appearance of a breast after mastectomy. The breast can be reconstructed at the same time the mastectomy is done (immediate reconstruction) or at a later date (delayed reconstruction). Surgeons may use silicone or saline-filled implants, or tissue from other parts of your body.

How do a woman and her doctor decide on the type of reconstruction and when she should have the procedure? The answer depends on the woman’s personal preferences, the size and shape of her breasts, the size and shape of her body, her level of physical exercise, details of her medical situation (such as how much skin is removed), and if she needs chemotherapy or radiation.

If you are thinking about breast reconstruction, please discuss this with your doctor when you are planning your treatment.

Lymph-Node Surgery

In the treatment of invasive cancer, whether a woman has a mastectomy or lumpectomy, she and her doctor usually need to know if the cancer has spread to the lymph nodes. When the lymph nodes are affected, there is an increased likelihood that cancer cells have spread through the bloodstream to other parts of the body.

Doctors once believed that removing as many lymph nodes as possible would reduce the risk of cancer spreading to other places and improve a woman’s chances for long-term survival. We now know that removing the lymph nodes probably does not improve the chance for long-term survival. But knowing whether lymph nodes are involved is important in selecting the best treatment to prevent cancer recurrence.

The only way to accurately determine if lymph nodes are involved is to remove and examine them under the microscope. This means removing some or all of the lymph nodes in the armpit. Two different surgical procedures are used to remove the lymph nodes: a sentinel lymph node biopsy and an axillary lymph node dissection. When an axillary lymph node dissection is done, all of the lymph nodes in the armpit are removed. The sentinel lymph node biopsy is a more limited surgery that only removes a few lymph nodes and is associated with fewer side effects.
For some women with invasive cancer, removing the underarm lymph nodes is optional. This includes:

• women with tumors so small and with such a favorable outlook that lymph node spread is unlikely
• instances where it would not affect whether adjuvant treatment is given
• elderly women
• women with serious medical conditions

Lymph node surgery is not necessary with pure ductal carcinoma in situ or pure lobular carcinoma in situ. A sentinel node biopsy may be done if the woman is having surgery (such as mastectomy) that would make it impossible to do the sentinel node biopsy procedure if invasive cancer were found in the tissue removed during the surgery.

The surgical technique used to remove lymph nodes from under the armpit depends on the personal circumstances of the patient. If there are enlarged lymph nodes with apparent spread of the cancer, or the lymph nodes are otherwise found to be involved with cancer, then complete axillary lymph dissection is necessary. However, for women with no apparent signs of cancer spread to the lymph nodes who have not received prior chemo­therapy or hormone therapy, the sentinel lymph node biopsy is the preferred procedure because it is associated with fewer side effects (see the discussion, “Side Effects of Lymph Node Surgery” below) and is as effective as axillary lymph node dissection in finding cancer in the lymph nodes.

In the sentinel lymph node biopsy pro­cedure, the surgeon finds and removes the “sentinel nodes,” the first few lymph nodes into which a tumor drains. These are the lymph nodes most likely to contain cancer cells. To find these so-called “sentinel lymph nodes,” the surgeon injects a radioactive substance and/or a blue dye under the nipple or into the area around the tumor. Lymphatic vessels carry these substances into the sentinel lymph nodes and provide the doctor with a “lymph node map.” The doctor can either see the blue dye or detect the radioactivity with a Geiger counter. The surgeon then removes the marked nodes for examination by the pathologist.

If the sentinel node contains cancer, the surgeon removes more lymph nodes in the armpit (axillary dissection). This may be done at the same time or several days after the original sentinel node biopsy. If the sentinel node is cancer-free, the patient will not need more lymph node surgery and can avoid the side effects of full lymph node surgery. However, this limited sampling of lymph nodes is not appropriate for some women.

Since the sentinel lymph node biopsy is relatively new, not all surgeons have experience performing this procedure. Even though the sentinel lymph node biopsy is the preferred method of lymph node surgery for most women without apparent signs of cancer spread to the lymph nodes, it should be considered only if it will be done by a team experienced with this technique. If you are an appropriate candidate for a sentinel lymph node biopsy, but an experienced sentinel lymph node team is not initially available, discuss the possibility of a referral to such a team with your doctor.

Side Effects of Lymph Node Surgery

Side effects of lymph node surgery can be bothersome to many women. The side effects can occur with either the full axillary lymph node dissection or with sentinel lymph node biopsy. Side effects are much less common and less severe with the sentinel lymph node procedure.
Side effects of lymph node surgery include:

• temporary or permanent numbness of the skin on the inside of the upper arm
• temporary limitation of arm and shoulder movements
• swelling of the breast and arm called lymphedema

Lymphedema is the most significant of these side effects. If it develops it may be permanent. Most women who develop lymphedema find it bothersome but not disabling. No one can predict which patients will develop this condition or when it will develop. Lymphedema can develop just after surgery, or even months or years later. Significant lymphedema occurs in about 13% of women who have axillary lymph node dissection and in up to 5% of women who have sentinel lymph node biopsy.

With care, patients can take steps to help avoid lymphedema or at least keep it under control. Talk to your doctor for more details.

Some of the steps to take to help avoid lymphedema include:

• Avoid having blood drawn from or IV’s inserted into the arm on the side of the lymph node surgery.
• Do not allow a blood pressure cuff to be placed on that arm. If you are in the hospital, tell all health care workers about your arm.
• If your arm or hand feels tight or swollen, don’t ignore it. Tell your doctor immediately.
• If needed, wear a well-fitted compression sleeve.
• Wear gloves when gardening or doing other things that are likely to lead to cuts.
• For more information on lymphedema, call the American Cancer society at 1-800-ACS-2345 and ask for Lymphedema: What Every Women With Breast Cancer Should Know.

Radiation Therapy

Radiation therapy uses a beam of high-energy rays (or particles) to destroy cancer cells left behind in the breast, chest wall, or lymph nodes after surgery. Radiation may also be needed after mastectomy in cases with either a large breast tumor, or when cancer is found in the lymph nodes.

This type of treatment can be given in several ways.

• External beam radiation delivers radiation from a machine outside the body. This is the typical radiation therapy given after lumpectomy and is given to the entire breast with an extra dose (“boost”) to the site of the tumor. It is usually given 5 days a week for a course of 6 to 7 weeks.
• Brachytherapy, also called internal radiation or interstitial radiation, describes the placement of radioactive materials (often called “seeds”) in or near where the tumor was removed. They may be placed in the lumpectomy site to “boost’ the radiation dose in addition to external beam radiation therapy.

Recently there has been interest in limiting radiation therapy only to the site of the lumpectomy, referred to as partial breast irradiation. This is based on the observation that when breast cancer recurs in the breast, the most common place is in the site of the original tumor. Brachytherapy is one technique of partial breast irradiation. External beam radiation therapy also can be used to deliver partial breast irradiation.

The extent of radiation depends on whether or not a lumpectomy or mastectomy was done and whether or not lymph nodes are involved. If a lumpectomy was done, the entire breast receives radiation with an extra boost of radiation to the area in the breast where the cancer was removed to prevent it from coming back in that area.

If the surgery was mastectomy, radiation is given to the entire area of the skin and muscle where the mastectomy was done if the tumor was over 5 cm in size, or if the tumor was close to the edge of the removed mastectomy tissue.

In patients who have had lumpectomy or mastectomy, further radiation may be recommended if the cancer has spread to the lymph nodes. Radiation may be given to the area just above the collarbone and along the breastbone, depending on the number and location of involved lymph nodes.

Side effects most likely to occur from radiation include swelling and heaviness in the breast, sunburn-like skin changes in the treated area, and fatigue. Changes to the breast tissue and skin usually go away in 6 to 12 months. In some women, the breast becomes smaller and firmer after radiation therapy. There may also be some aching in the breast, and rarely a rib fracture or second cancer may be caused by the radiation.

Systemic Treatment

To reach cancer cells that may have spread beyond the breast and nearby tissues, doctors use drugs that can be given by pills or by injection. This type of treatment is called Systemic therapy. Examples of systemic treatment include chemotherapy, hormone therapy, and monoclonal monoclonal antibody therapy. Examples of systemic treatment include chemotherapy, hormone therapy, and other types of targeted therapy. Targeted therapies such as hormonal therapy are only helpful if the tumor is hormone receptor-positive, and targeted therapies such as trastuzumab and lapatinib are only effective if the tumor is HER2-positive. (See discussion of targeted therapy.) Even in the early stages of the disease, cancer cells can break away from the breast and spread through the bloodstream. These cells usually don’t cause symptoms, they don’t show up on an x-ray, and they can’t be felt during a physical examination. But if they are allowed to grow, they can establish new tumors in other places in the body. Systemic treatment given to patients who have no evidence of spread of cancer but who are at risk of developing spread of the cancer is called adjuvant therapy. The goal of adjuvant therapy is to kill undetected cancer cells that have traveled from the breast.

Women who have invasive breast cancer should receive adjuvant therapy, except those with very small or well-differentiated tumors. For example, women with hormone receptor-positive disease will receive hormone therapy, and women with HER2-positive tumors greater than 1 cm in diameter or with involvement of lymph nodes will receive targeted therapy with trastuzumab. Chemotherapy may also be recommended based on the size of the tumor, grade of the tumor, and presence or absence of lymph node involvement. For women with breast cancers with hormone receptor-negative tumors, hormone therapy is not effective and in women with HER2-negative tumors, trastuzumab is not effective. In women with tumors that are hormone receptor- and HER2-negative, the only decision is whether or not to receive chemotherapy.

In most cases, systemic treatment is given soon after surgery using the results of the surgery and pathology evaluation to determine the best choice treatment. In some cases, the systemic therapy is given to patients after a needle biopsy, but before lumpectomy or mastectomy. This preoperative chemotherapy is called neoadjuvant treatment. Oncologists give patients neoadjuvant treatment to try to shrink the tumor enough to make surgical removal easier. This may allow women who would otherwise need mastectomy to have breast-conserving surgery.

For women whose breast cancer has spread to other organs in the body (metastases), systemic treatment is the main treatment. This treatment may be chemotherapy, hormone therapy, other types of targeted therapy, or a combination of these types of therapy.

Chemotherapy

Chemotherapy uses drugs that are toxic to and often kill cancer cells. Usually these cancer-fighting drugs are given intravenously (injected into a vein) or by mouth. Either way, the drugs travel through the bloodstream to the entire body. Doctors who prescribe these drugs (medical oncologists) sometimes use only a single drug and other times use a combination of drugs.

When chemotherapy is given after surgery for early stage breast cancer, it is called adjuvant chemotherapy. Sometimes chemo­therapy is given before surgery. This is called neoadjuvant chemotherapy. In most cases, adjuvant or neoadjuvant chemotherapy is most effective when combinations of drugs are used together. Chemotherapy may also be given to treat breast cancer that has spread to places other than the breast or lymph nodes. Both single drugs and combinations of drugs are often used in the treatment of breast cancer that has spread. Clinical research studies over the last 30 years have determined which chemotherapy drugs are most effective. With continued research, even better combinations may be discovered.

Listed below are common combinations of adjuvant chemotherapy drugs, divided into combinations for women with HER2-positive tumors and HER2-negative tumors. There are also lists of common chemotherapy options for women who have recurrent breast cancer or metastatic breast cancer.

Doctors give chemotherapy in cycles, with each period of treatment followed by a rest period. The chemotherapy is given on the first day of each cycle (and sometimes on other days of the cycle), and then the body is given time to recover from the effects of chemo­therapy. The chemotherapy drugs are then repeated to start the next cycle. The time between giving the chemotherapy drugs varies according to the specific chemotherapy drug or combination of drugs. Adjuvant chemo­therapy usually lasts for a total time of 3 to 6 months depending on the drugs used.
The side effects of chemotherapy depend on the type of drugs used, the amount taken, and the length of treatment. Some women have many side effects while other women have few side effects.

• Doxorubicin and epirubicin may cause heart damage but this is uncommon in people who do not have a history of heart disease. If you know you have heart disease or there is concern you might have heart disease, your doctor may suggest special heart tests before you use these drugs and may suggest other chemotherapy drugs if your heart function is weakened.
• Temporary side effects often include loss of appetite, nausea and vomiting, fatigue, mouth sores, and hair loss.
• Chemotherapy may cause menstrual cycles to stop either temporarily or permanently.
• Lowering of the blood counts from chemotherapy is the most common serious side effect of chemotherapy. Chemotherapy does this by damaging the blood producing cells of the bone marrow. A drop in white blood cells can raise a patient’s risk of infection; a shortage of blood platelets can cause bleeding or bruising after minor cuts or injuries; and a decline in red blood cells can lead to fatigue.

There are treatments for these side effects. There are excellent drugs that prevent or at least reduce nausea and vomiting. A group of drugs, called growth factors, stimulate the production of white blood cells or red blood cells and can help bone marrow recover after chemotherapy and prevent problems resulting from low blood counts. Although these drugs are often not necessary, doctors have been using them to allow them to give the chemotherapy more often. Talk with your doctor about which treatment will be right for you.

Ask your doctor or call the American Cancer Society and ask for a copy of specific guidelines for treating many of the side effects caused by chemotherapy, such as Nausea and Vomiting Treatment Guidelines for Patients with Cancer and Fever and Neutropenia Treatment Guidelines for Patients with Cancer.

Premenopausal women will often develop early menopause and infertility from chemo­therapy drugs. The older a woman is when she receives chemotherapy, the more likely it is she will stop menstruating or lose her ability to become pregnant. Some chemotherapy drugs are more likely to do this than others. However, you cannot depend on chemo­therapy to prevent pregnancy, and getting pregnant while receiving chemotherapy could lead to birth defects and interfere with treatment. Therefore, premenopausal women should use non-hormonal forms of birth control while receiving chemotherapy. It is safe to have children after chemotherapy and certain types of chemotherapy can be given in the second and third trimester of pregnancy to women who are diagnosed with breast cancer during pregnancy (See discussion of breast cancer in pregnancy on page 31), but it’s not safe to get pregnant while on treatment.

Targeted Therapy

Targeted therapy is a form of treatment that attacks specific sites and/or processes that are important to the function of cancer cells. In many cases of targeted therapy, higher levels of the target (for example, the HER2 receptor) in the cancer cells are associated with greater benefit for the patient when the therapy (such as, trastuzumab) is given.

Trastuzumab (Herceptin®) is a monoclonal antibody therapy that targets the HER2 receptor that is on the surface of the breast cancer cells of some patients. Trastuzumab is an important treatment option for some patients with HER2-positive tumors. It may be used as adjuvant therapy with chemotherapy to reduce the risk of recurrent breast cancer, as neoadjuvant therapy combined with chemotherapy to shrink the size of the tumor before surgery, or as treatment for metastatic breast cancer. Trastuzumab can cause heart damage and should be used cautiously when combined with other heart damaging drugs, such as doxorubicin and epirubicin.

Bevacizumab (Avastin®) is another monoclonal antibody that may be used in patients with metastatic breast cancer. It is used in combination with the chemotherapy drug paclitaxel. Bevacizumab works by preventing the growth of new blood vessels that supply tumor cells with the blood, oxygen, and other nutrients they need to grow. Bevacizumab can cause side effects such as a delay in wound healing with bleeding, high blood pressure, or kidney damage.

Lapatinib (Tykerb®) is another type of targeted therapy for patients with advanced or metastatic breast cancer. This drug is taken orally and is used in combination with another oral drug, capecitabine. It works by getting inside cells and interfering with processes involving both the HER2 receptor and another cell surface receptor called HER1. Use of lapatinib may cause certain side effects such as diarrhea and acne.

Hormone Therapy

Hormone therapy is a type of targeted therapy that targets the hormone receptors of cancer cells. Estrogen, a hormone produced mostly by the ovaries, but also from hormones produced by the adrenal glands and fat tissue in a woman’s body, causes some breast cancers to grow. Several approaches can be used to block the effect of estrogen or to lower estrogen levels. These approaches can be divided into two main groups:

• Drugs that block the effect of estrogen on cancer cells, called anti-estrogens. These medicines do not decrease estrogen levels; instead, they prevent estrogen from causing the breast cancer cells to grow.
• Drugs or treatments that lower the production of estrogen in the body.

These treatments are used in two situations:

• Women who have hormone receptor-positive breast cancer that appears to have been completely removed by surgery. This adjuvant therapy reduces the risk of recurrent breast cancer or the spread of breast cancer to other parts of the body. Adjuvant therapy may also include chemotherapy or trastuzumab.
• Women with hormone receptor- positive breast cancer that has spread to other parts of the body or in whom the cancer has come back.

Hormone drugs are only effective in women with breast cancer tumors that have increased levels of estrogen or progesterone receptors. Every breast cancer should be tested for these receptors, and you should ask your doctor for the results of this test on your cancer. If the cancer is negative for both these receptors, then the hormone drugs are of no benefit.

Often a combination of hormone therapy and chemotherapy is used in the treatment of breast cancer.

Hormone therapy is often recommended for a period of 5 years or longer when used as adjuvant treatment. It can also be used for long periods of time in the treatment of metastatic breast cancer. If you are taking hormone therapy, it is very important that the pills be taken according to the recommendations of your doctor and pharmacist. Although hormone therapy can have side effects and the benefits of the treatment may not be readily apparent, it is very important that you do not compromise your care by stopping the drug or by skipping days or weeks of therapy without telling your doctor. If you are experiencing side effects, discuss these with your cancer treatment team.

Anti-Estrogen Drugs

Tamoxifen is the antiestrogen drug used most often. Taking tamoxifen as adjuvant therapy after surgery, usually for five years, reduces the chance of hormone receptor-positive breast cancer (for example, invasive breast cancer or DCIS) coming back. Tamoxifen is also used to treat metastatic breast cancer, and to reduce the risk of breast cancer in pre- and postmenopausal women with LCIS.

In many women, tamoxifen causes the symptoms of menopause, including hot flashes, vaginal discharge, and mood swings. Tamoxifen has two rare, but more serious side effects. These are a slightly increased risk of developing cancer of the lining of the uterus (endometrial cancer) and uterine sarcoma, and a slightly increased risk of developing blood clots. For most women with breast cancer, the benefits of taking the drug far outweigh the risks.

Toremifene (Fareston®) is another anti­estrogen closely related to tamoxifen. It may be an option for postmenopausal women with metastatic breast cancer.

Fulvestrant (Faslodex®) is a newer drug that reduces the number of estrogen receptors. It is often effective in postmenopausal women even if the breast cancer is no longer responding to tamoxifen. Hot flashes, mild nausea and fatigue are the major side effects of fulvestrant.
Raloxifene (Evista®) is a drug that acts as an antiestrogen on breast tissue. It is used to reduce the risk of breast cancer in postmenopausal women with LCIS, but is not used to treat DCIS or invasive breast cancer.

Drugs that Lower Estrogen Levels – Aromatase Inhibitors

Aromatase inhibitors stop estrogen production in postmenopausal women. Three drugs in this category have been approved for treatment of breast cancer: anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®). They work by blocking an enzyme that makes estrogen in postmenopausal women. They cannot stop the ovaries of premenopausal women from making estrogen. For this reason they are only effective and only used in postmenopausal women. For premenopausal women, tamoxifen remains the best drug to use.

The aromatase inhibitors have been compared with tamoxifen as adjuvant hormone therapy. They have fewer side effects than tamoxifen because they don’t cause cancer of the uterus and very rarely cause blood clots. They can, however, cause loss of calcium from bone and bone fractures because they remove all estrogen from a postmenopausal woman. They also may cause hot flashes and sometimes joint pain.

The aromatase inhibitors are more effective than tamoxifen alone in preventing breast cancer from coming back in postmenopausal women. Based on recent studies, many doctors recommend including an aromatase inhibitor in the adjuvant hormone treatment of postmenopausal women with hormone receptor-positive breast cancer.

Hormone Therapy and Menopause

As discussed above, the aromatase inhibitors are not recommended for premenopausal women. Therefore, determining whether the patient is menopausal is important in making treatment decisions. This is not as simple as it may sound, because menstrual periods can stop as a side effect of treatment while the ovaries continue to make estrogen. Also, sometimes chemotherapy stops the ovaries from making estrogen for a short period of time, but when the ovaries recover from the chemotherapy they start making estrogen again. Therefore, if the use of an aromatase inhibitor is considered in a young women who has intact ovaries, repeated monitoring of hormone levels such as estradiol and follicle-stimulating hormone (FSH) may be required to make sure that the woman is truly postmenopausal.

Ovarian Ablation

The ovaries are the source of most estrogen in premenopausal women. Destroying or blocking the ability of the ovaries to produce estrogen (called ablation) may be an effective hormone therapy to treat premenopausal women with cancers that are positive for the estrogen or progesterone receptors. Destruction or blockage of the ovary production of estrogen can be done in a number of ways:

• The ovaries can be removed by surgery (oophorectomy).
• Radiation therapy can be given to the ovaries.
• Drugs called LHRH (luteinizing hormone-releasing hormone) agonists or antagonists prevent estrogen production by the ovaries. These include goserelin (Zoladex®) and leuprolide (Lupron® or Eligard®). However, if a woman was premenopausal before taking these drugs, it is not possible to determine if she has become postmenopausal while she is still receiving this type of therapy.

Bisphosphonates

Bisphosphonates are used in breast cancer treatment to strengthen bones that have been weakened by invading breast cancer cells. The most commonly used bisphosphonates in breast cancer treatment are pamidronate (Aredia®) and zoledronate (Zometa®). These drugs are not used unless cancer has spread to the bone.

Hormonal treatment with the aromatase inhibitors may also weaken the bones by causing loss of calcium from the bone (called osteoporosis) and thus increase the risk of a fracture. Therefore, patients treated with an aromatase inhibitor should have their bone strength tested (called a bone density test) to determine if medication to strengthen their bones would be appropriate. Some patients may go into early menopause due to the side effects of chemotherapy. Menopause is associated with bone loss, too. These patients may also undergo a bone density test to evaluate the presence of osteoporosis. There are a number of medications, including some oral forms of bisphosphonates, to treat the loss of calcium from bone that is not caused by direct breast cancer in the bone. Talk with your doctor about whether one of these medications is right for you.

 
Treatment of Breast Cancer During Pregnancy

Breast cancer is diagnosed in about 1 pregnant woman out of 3,000. Radiation therapy during pregnancy is known to increase the risk of birth defects, so it is not recommended for pregnant women with breast cancer.

For this reason, breast conservation therapy (lumpectomy and radiation therapy) is not considered an option if radiation cannot be delayed until it is safe to deliver the baby. However, breast biopsy procedures and even modified radical mastectomy are safe for the mother and fetus.

 
Treatment of Pain and Other Symptoms

Most of this booklet discusses ways to remove or destroy breast cancer cells or to slow their growth. But helping you feel as well as you can and continuing to do the things you enjoy doing are important goals, too. Don’t hesitate to discuss your symptoms or how you feel with your cancer care team. There are effective and safe ways to treat pain, other symptoms of breast cancer, and most of the side effects caused by breast cancer treatment. If you don’t tell your health care team, they may have no way of knowing about your problems.

 
Complementary or Alternative Therapies

Complementary and alternative medicines are different kinds of health care practices, systems, and products that are not part of your usual medical treatment. They may include Chinese herbs, special supplements, acupuncture, massage, and a host of other types of treatment. You may hear about all sorts of these treatments from your family and friends. People may offer all sorts of suggestions, such as vitamins, herbs, stress reduction, and more, as a treatment for your cancer or to help you feel better. Most of these methods are of unproven value in the treatment of cancer, although some have been tested in people with cancer.

The American Cancer Society defines complementary medicine or methods as those that are used along with your regular medical care. If these treatments are carefully chosen and managed, they may add to your comfort and well-being. Some of these methods have been tested, while others have not. Some have shown possible benefit, while others have not proven helpful. Some of these treatments have harmful effects as well.

Alternative medicines are defined as those that are used instead of regular medical care. Even though some of these methods have proven not to be helpful, and some have even proven harmful, they are often still promoted as “cures.” If you choose these alternatives, it is important to know that even the methods that do not cause harm may reduce your chance of fighting your cancer by delaying or replacing regular, proven forms of cancer treatment.

There is a great deal of interest today in complementary and alternative treatments for cancer. Many are being studied to find out if they are helpful to people with cancer.

Before changing your treatment or adding any of these methods, it is best to discuss this openly with your doctor or nurse. Some methods can be safely used along with standard medical treatment. Others, however, can interfere with standard treatment or cause serious side effects. More information about specific complementary and alternative methods of cancer treatment is available through the American Cancer Society’s toll-free number at 1-800-ACS-2345 or on our Web site at www.cancer.org.

 
Other Things to Consider During and After Treatment

During and after your treatment for breast cancer you may be able to speed up your recovery and improve your quality of life by taking an active role in your care. Learn about the benefits and drawbacks of each of your treatment options, and talk to your cancer care team if there is anything you do not understand. Learn about and look out for side effects of treatment, and report these to your cancer care team right away so they can take steps to ease them and shorten their duration.

Remember that your body is as unique as your personality and your fingerprints. Although understanding your cancer’s stage and learning about your treatment options can help predict what health problems you may face, no one can say for sure how you will respond to cancer or its treatment.

You may have special strengths such as a habit of excellent nutrition and physical activity, a strong family support system, or a deep faith, and these strengths may make a difference in how you respond to cancer treatment. There are also experienced professionals in mental health services, social work services, and pastoral services who may help you and your family in coping with your illness.

You can also help in your own recovery from cancer by making healthy lifestyle choices. If you use tobacco, stop now. Quitting will improve your overall health and the full return of the sense of smell may help you enjoy a healthy diet during recovery. If you use alcohol, limit how much you drink. Have no more than 1 drink per day. Good nutrition can help you get better after treatment. Eat a nutritious and balanced diet, with plenty of fruits, vegetables, and whole grain foods. Ask your cancer care team if you may benefit from a special diet or a referral to a dietician (a nutrition expert). Your cancer care team may have special recommendations for people who have had chemotherapy, radiation, or surgery.

If you are being treated for cancer, be aware of the battle that is going on in your body. Radiation therapy and chemotherapy add to the fatigue caused by the disease itself. To help you with the fatigue, plan your daily activities around when you feel your best. Get plenty of sleep at night. And ask your cancer care team about a daily exercise program to help you feel better.

A woman’s choice of treatment will likely be influenced by her age, the image she has of herself and her body, her hopes and fears, and her stage in life. For example, many women select breast-conserving surgery with radiation therapy over a mastectomy for body image reasons. On the other hand, some women who choose mastectomy may want the affected area removed, regardless of the effect on their body image, and others may be more concerned about the side effects of radiation therapy than body image.

Other issues that concern women include loss of hair from chemotherapy and the changes of the breast from radiation therapy. Women on chemotherapy tend to gain weight and it is important to continue to eat a healthy diet and exercise as much as your energy level will permit. In addition to these body changes, women may also be concerned about the outcome of their treatment. These are all factors that affect how a woman will make decisions about her treatment, how she views herself, and how she feels about her treatment.

Concerns about sexuality are often very worrisome to a woman with breast cancer. Some treatments for breast cancer can change a woman’s hormone levels and may have a negative impact on sexual interest and/or response. A diagnosis of breast cancer when a woman is in her 20s or 30s is especially difficult because choosing a partner and childbearing are often very important during this period. Relationship issues are also important because the diagnosis can be very distressing for the partner, as well as the patient. Partners are usually concerned about how to express their love physically and emotionally during and after treatment. Talk to your cancer care team about these issues and contact the American Cancer Society for a copy of Sexuality and Cancer: For the Woman with Cancer and Her Partner.

Suggestions that may help a woman adjust to changes in her body image include looking at and touching her body; seeking the support of others, preferably before surgery; involving her partner as soon as possible after surgery; and openly talking about the feelings, needs, and wants created by her changed image.

A cancer diagnosis and its treatment are major life challenges; cancer affects you and everyone who cares for you. Almost everyone who has been through cancer can benefit from getting some type of support. What’s best for you depends on your situation and personality. Some people feel safe in peer-support groups or education groups. Others would rather talk in an informal setting, such as church. Others may feel more at ease talking one-on-one with a trusted friend or counselor. Whatever your source of strength or comfort, make sure you have a place to go with your concerns. If you need help with this, contact your hospital’s social service department or the American Cancer Society for help in finding counselors or other services.
Clinical Trials

Clinical Trials

There are a lot of decisions to make after you find out you have cancer. One of the most important decisions you will make is deciding which treatment is best for you. You may have heard about clinical trials being done for your type of cancer. Or maybe someone on your health care team has mentioned a clinical trial to you. Clinical trials are one way to get state-of-the art cancer care. Still, they are not right for everyone.

Here we will give you a brief review of clinical trials. Talking to your health care team, your family, and your friends can help you make the best treatment choice for you.

What Are Clinical Trials?

Clinical trials are carefully controlled research studies that are done with patients. These studies test whether a new treatment is safe and how well it works in patients, or look at new ways to diagnose or prevent a disease. Clinical trials have led to many advances in cancer prevention, diagnosis, and treatment.

The Purpose of Clinical Trials

Clinical trials are done to get a closer look at promising new treatments or procedures in patients. A clinical trial is only done when there is good reason to believe that the treatment, test, or procedure being studied may be better than the one used now. Treatments used in clinical trials are often found to have real benefits and may go on to become tomorrow’s standard treatment.

Clinical trials can focus on many things, such as:

• new uses of drugs that are already approved by the US Food and Drug Administration (FDA)
• new drugs that have not yet been approved by the FDA
• ‑non-drug treatments (such as radiation therapy)
• medical procedures (such as types of surgery)
• herbs and vitamins
• tools to improve the ways medicines or diagnostic tests are used
• medicines or procedures to relieve symptoms or improve comfort
• combinations of treatments and procedures

Researchers conduct studies of new treatments to try to answer the following questions:

• Is the treatment helpful?
• What’s the best way to give it?
• Does it work better than other treatments already available?
• What side effects does the treatment cause?
• Are there more or fewer side effects than the standard treatment used now?
• Do the benefits outweigh the side effects?
• In which patients is the treatment most likely to be helpful?

Phases of clinical trials

There are 4 phases of clinical trials, which are numbered I, II, III, and IV. We will use the example of testing a new cancer treatment drug to look at what each phase is like.

Phase I Clinical Trials
The purpose of a phase I study is to find the best way to give a new treatment safely to patients. The cancer care team closely watches patients for any harmful side effects.

For phase I studies, the drug has already been tested in lab and animal studies, but the side effects in patients are not fully known. Doctors start by giving very low doses of the drug to the first patients and increase the doses for later groups of patients until side effects appear or the desired effect is seen. Doctors are hoping to help patients, but the main purpose of a phase I trial is to test the safety of the drug.

Phase I clinical trials are often done in small groups of people with different cancers that have not responded to standard treatment or that keep coming back (recurring) after treatment. If a drug is found to be reasonably safe in phase I studies, it can be tested in a phase II clinical trial.

Phase II Clinical Trials
These studies are designed to see if the drug works. Patients are given the best dose as determined from phase I studies. They are closely watched for an effect on the cancer. The cancer care team also looks for side effects.

Phase II trials are often done in larger groups of patients with a specific cancer type in whom standard treatments aren’t working. If a drug is found to be effective in phase II studies, it can be tested in a phase III clinical trial.

Phase III Clinical Trials
Phase III studies involve large numbers of patients — most often those who have just been diagnosed with a specific type of cancer. Phase III clinical trials often enroll hundreds of patients.
Often, these studies are randomized. This means that patients are randomly put in one of two (or more) groups. One group (called the control group) gets the standard, most accepted treatment. Other group(s) get the new one(s) being studied. All patients in phase III studies are closely watched. The study will be stopped early if the side effects of the new treatment are too severe or if one group has much better results than the others.

Phase III clinical trials are usually needed before the FDA will approve a treatment for use by the general public.

Phase IV clinical trials
Once a drug has been approved by the FDA and is available for all patients, it is still studied in other clinical trials (sometimes referred to as phase IV studies). This way more can be learned about short-term and long-term side effects and safety as the drug is used in larger numbers of patients with many types of diseases. Doctors can also learn more about how well the drug works, and if it might be helpful when used in other ways (such as in combination with other treatments).

Deciding to Enter a Clinical Trial

If you would like to take part in a clinical trial, you should begin by asking your doctor if your clinic or hospital conducts clinical trials. There are requirements you must meet to take part in any clinical trial. But whether or not you enter (enroll in) a clinical trial is completely up to you.

Your doctors and nurses will explain the study to you in detail. They will go over the possible risks and benefits and give you a form to read and sign. The form says that you understand the clinical trial and want to take part in it. This process is known as giving your informed consent. Even after reading and signing the form and after the clinical trial begins, you are free to leave the study at any time, for any reason.

Taking part in a clinical trial does not keep you from getting any other medical care you may need.
To find out more about clinical trials, talk to your cancer care team. Among the questions you should ask are:

• Is there a clinical trial that I could take part in?
  
• What is the purpose of the study?
  
• What kinds of tests and treatments does the study involve?
  
• What does this treatment do? Has it been used before?
  
• Will I know which treatment I receive?
  
• What is likely to happen in my case with, or without, this new treatment?
  
• What are my other choices and their pros and cons?
  
• How could the study affect my daily life?
  
• What side effects can I expect from the study? Can the side effects be controlled?
  
• Will I have to stay in the hospital? If so, how often and for how long?
  
• Will the study cost me anything? Will any of the treatment be free?
  
• If I am harmed as a result of the research, what treatment would I be entitled to?
  
• What type of long-term follow-up care is part of the study?
  
• Has the treatment been used to treat other types of cancers?

How Can I Find Out More About Clinical Trials That Might Be Right For Me?

The American Cancer Society offers a clinical trials matching service for patients, their family, and friends. You can reach this service at 1-800-303-5691 or on our Web site at http://clinicaltrials.cancer.org.

Based on the information you give about your cancer type, stage, and previous treatments, this service can put together a list of clinical trials that match your medical needs. The service will also ask where you live and whether you are willing to travel so that it can look for a treatment center that you can get to.

You can also get a list of current clinical trials by calling the National Cancer Institute’s Cancer Information Service toll free at 1-800-4-CANCER (1-800-422-6237) or by visiting the NCI clinical trials Web site at (www.cancer.gov/clinical_trials/).

STAGES OF BREAST CANCER

For more information on these treatment guidelines, or on cancer in general, call the NCCN at 1-888-909-NCCN or the American Cancer Society at 1-800-ACS-2345. Or you can visit these organizations’ web sites at www.cancer.org (ACS) and www.nccn.org (NCCN).

© 2007 by the National Comprehensive Cancer Network (NCCN) and the American Cancer Society (ACS). All rights reserved. The information herein may not be reproduced in any form for commercial purposes or downloaded and stored in any information-retrieval system without the express written permission of the NCCN and the ACS. Single copies of each page may be printed out for personal, noncommercial use only.