Trial Compares Standard Chemotherapy Schedules

By Mary Alice Hartsock, LBBC Staff; reviewed by Evelyn Robles Rodriguez, RN, MSN, APNC

A phase III trial for early breast cancer compares the schedule of two common chemotherapy treatments in improving disease-free survival

Trial Starts: 1/30/2008

Sponsored By: National Cancer Institute

A phase III trial seeks 4,646 women with early-stage breast cancer to compare the effectiveness and schedule of the standard chemotherapy combination doxorubicin (brand name: Adriamycin) and cyclophosphamide (brand name: Cytoxan) to paclitaxel (brand name: Taxol) alone.

The national clinical research group Cancer and Leukemia Group B is coordinating this trial, also known as CALGB-40101. The researchers want to find out whether paclitaxel (often called "T") works as well as the Adriamycin/Cytoxan (also called "AC") combination in improving disease-free survival, the length of time after treatment without evidence of the breast cancer returning. They are also testing these treatments given at two different schedules—four versus six treatments, given once every two weeks—to see whether the number of courses given influences the effectiveness of the treatment.

To take part in this study, you must have a diagnosis of stage I or stage II invasive breast cancer. You may have cancer present in up to three lymph nodes.

Study Background

Invasive disease is a type of breast cancer that begins in the ducts or lobules of the breast, grows into surrounding tissues and can travel to the lymph nodes. When invasive breast cancer travels to other places in the body, it is known as metastatic breast cancer.

Early-stage invasive disease requires surgery to remove the cancer. In some cases you may have a choice between removing the whole breast (mastectomy) or getting a lumpectomy, surgery to remove the cancer and a small rim of healthy tissue around it (the margin). Lumpectomy is often followed by radiation therapy.

For a number of reasons, some invasive breast cancers require chemotherapy, a systemic (whole body) treatment that kills microscopic cancer cells that may have traveled away from the breast and into the bloodstream. When chemotherapy is given after surgery, it is called adjuvant treatment.

Doctors recommend chemotherapy when they feel there is a high risk the cancer could return. Your doctor may describe a cancer as "high risk" based on the presence of cancer in the lymph nodes, the large size of a tumor, a lack of hormone receptors (as in triple-negative breast cancer) or other traits. You will learn more about the biology of the cancer from the results of your pathology tests and other genomic tests that look at the traits of the cancer. To learn more about these tests, download our free Guide to Understanding Treatment Decisions.

About the Study Medicines

The medicines in this trial are cyclophosphamide, doxorubicin and paclitaxel, all standard chemotherapy treatments for breast cancer.

Cyclophosphamide, which belongs to a class of medicines known as alkylating agents, damages the proteins that control growth in the genes of a tumor cell. Doxorubicin, an antitumor antibiotic in the anthracycline family, works by damaging the DNA and killing cancer cells. Paclitaxel, a taxane, blocks tumor growth by holding cell division in check.

These medicines are given in a variety of standard combinations, including AC followed by T. However, this combination carries some risk of serious, long-term side effects like heart problems or acute leukemia. Researchers are searching for equally effective treatments with less harmful potential long-term side effects.

Goals of CALGB-40101

The researchers will compare disease-free survival (time after treatment without evidence of disease) in women who take cyclophosphamide plus doxorubicin or paclitaxel alone. They also plan to compare time lived before death from breast cancer (overall survival), side effects and the effect of the therapy on menopausal status.

Structure of CALGB-40101

Trial participants will be divided randomly (assigned by chance) into four groups, or arms, based on menopausal status and hormone and HER2 receptor status:

• Arm I participants will receive doxorubicin and cyclophosphamide once every 14 days for four courses.
• Arm II participants will receive doxorubicin and cyclophosphamide once every 14 days for six courses.
• Arm III participants will receive paclitaxel for one hour once every 14 days for four courses.
• Arm IV participants will receive paclitaxel for one hour once every 14 days for six courses.

The researchers are recruiting only for arms I and III; the other two arms have been filled. Participants will be followed every six months for two years and then once a year for 15 years.

Trial Eligibility

You may be eligible to participate in CALGB-40101 if you have been diagnosed with early breast cancer that can be removed by surgery and:

• You have between zero andthree positive axillary lymph nodes
• Your doctor considers the cancer to be high risk
• You had a mastectomy or a lumpectomy in the past 84 days
• The cancer is not locally advanced, inflammatory or metastatic
• If the cancer is multicentric, or in multiple quadrants of the breast, your surgeon must have removed all the cancer during surgery

For more information about eligibility, visit the link at the end of this article.

What Else Do I Need to Know?

By participating in this trial, you could impact treatment options for women diagnosed with breast cancer in the future. You also could receive a treatment that may work more effectively than the standard treatment with fewer or less damaging long-term side effects.

Researchers are familiar with the side effects of cyclophosphamide, doxorubicin and paclitaxel, so your healthcare team can prepare you for and respond to any potential side effects. Your doctor can help you figure out whether this clinical trial is right for you.

Read more about this chemotherapy clinical trial.

For more information, contact: Lawrence Shulman, MD, (866) 790-4500

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