IRB Number:

1680-02

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

This study is being done to:
- Compare the effects (good and bad) of the standard chemotherapy, cyclophosphamide and doxorubicin (CA) with the chemotherapy drug, paclitaxel. These drugs are given after surgery, and this treatment is called adjuvant therapy.
- Compare the effects (good and bad) of eight weeks of treatment with 12 weeks of treatment using CA or paclitaxel.
CA treatment (given into a vein every two or three weeks for four treatments) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of breast cancer. Paclitaxel given after combination chemotherapy has been approved for the adjuvant treatment of breast cancer that has spread to the lymph nodes. Paclitaxel is also approved for the treatment of breast cancer that has grown or that has spread to other parts of the body after previous chemotherapy. The use of paclitaxel as an adjuvant treatment for breast cancer that has not spread to the lymph nodes as used in this study, are considered to be investigational or research.

Who is Eligible to Participate in the Study?

-Women age 18 or older
-Diagnosed with invasive carcinoma of the breast with 0-3 positive axillary lymph nodes
-High-risk" disease that warrants chemotherapy (ultimately determined by the treating physician)
-Modified radical mastectomy or lumpectomy within the past 84 days required
-Any estrogen and/or progesterone receptor status

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

Patients will be put in one of two groups by chance (as in the flip of a coin). A computerized selection process will be used to decide the treatment group they are assigned. Neither the patient nor their doctor will choose which group the patient will be assigned. A patient will have an equal chance of being put in either of the two groups:
Group 1: CA for four cycles (eight weeks)
Group 2: Paclitaxel for four cycles (eight weeks)

Group 1
If a patient is put in this group, they will be given cyclophosphamide through a vein, followed by doxorubicin through a vein on day 1, every 14 days. This 14-day period is called a treatment cycle. The patient will get four cycles of this treatment (CA).

Group 2
If the patient is put in this group, they will be given medications before the paclitaxel to prevent allergic reactions, which can be severe. The patient will then be given paclitaxel as an outpatient in the clinic. They will be given the paclitaxel through a vein, over three hours on day 1, every 14 days. This 14-day period is called a treatment cycle. The patient will get this treatment every 14 days for four cycles.

Both Treatment Groups
Filgrastim or sargramostim, medications that are stimulators of white blood cell growth, is recommended to be given as an injection under the skin to help prevent infections, for about a week after each treatment, beginning 2 days after the treatment and continuing until about 10 days after the treatment. Pegfilgrastim is another medication that stimulates white blood cell growth. The patient, a family member, or a friend may be taught to give these injections at home. It is given as an injection under the skin, as a single dose, 24-36 hours following each cycle of treatment.

After the patient is done with the study treatment, their doctor may suggest hormonal therapy if their breast cancer is the type that responds to hormones. Tamoxifen may be suggested for women who have not yet gone into menopause. Tamoxifen, anastrozole, exemestane or letrozole may be suggested for women who have gone into menopause. Also, tamoxifen may be suggested for women who have not yet gone into menopause.

If the type of surgery the patient had to remove their breast cancer was a "lumpectomy", they will get radiation therapy to the breast. If the type of surgery the patient had was a mastectomy, their doctor may suggest that they get radiation therapy to the breast. If they are going to get radiation therapy, it will be given either before the study chemotherapy has been started or after it is done.

If the patient's breast cancer is the type that is responsive to trastuzumab (also known as
Herceptin®) their doctor may recommend treatment with this drug. The patient should discuss with their doctor whether Herceptin® (trastuzumab) is right for the patient.

If the patient's breast cancer returns in the breast or an area outside the breast, or if the patient experiences bad side effects while taking part in this study, their study doctor may recommend that the patient stop taking part in the study.

Testing and Follow-up
Patients will have the following routine tests and procedures before treatment begins:
- Medical history and physical examination
- Blood tests
- Electrocardiogram (EKG)
- Chest X-ray

During the time that they are getting treatment, a physical exam and blood tests will be done on day 1 of each treatment cycle. EKGs will be done if their study doctor feels it is necessary.

After treatment is done, the physical exams will be done every six months for two years, then once a year for up to 15 years. The blood tests and chest X-rays will be done as their doctor feels necessary.

How long will the Study run?

Patients will get study treatment for about two months. After the treatment is done, the researcher will follow the patient's medical condition for up to 15 years to learn about the long-term effects of the study treatment.

Sponsor(s): Cancer and Leukemia Group B (CALGB, National Cancer Institute (NCI)

Study Activation/Registration Date: 10/18/2002

IRB Review and Approval Date: 09/13/2002

Study Type: Treatment

Projected Accrual: The plan is to have up to 4646 patients participate from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Edith A. Perez, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL

Last updated: 06/18/2008