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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Study of the Addition of Octreotide Pamoate (SMS 201-995 pa LAR) to Tamoxifen Alone or to Tamoxifen and Chemotherapy in Women With Axillary Node Negative, Estrogen Receptor Positive, Primary Invasive Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	Not specified	NCI	NSABP-B-29 NCT00002967

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells.

Randomized phase III trial to study the effectiveness of tamoxifen, octreotide, and chemotherapy in treating women who have stage I or stage II breast cancer.

Eligibility:

• Must have undergone a mastectomy or lumpectomy with axillary lymph node dissection
• No bilateral breast cancer
• No more than 9 weeks since diagnosis
• No bone metastases
• No previous biological therapy, chemotherapy, hormone therapy, or radiation therapy for breast cancer
• At least 2 weeks since surgery
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of four groups. Patients in group one will receive tamoxifen by mouth once a day for 5 years. Patients in group two will receive tamoxifen by mouth once a day for 5 years plus injections of octreotide every 3-4 weeks for a total of 27 injections. Patients in group three will receive infusions of doxorubicin and cyclophosphamide every 3 weeks for four courses plus tamoxifen as in group one. Patients in group four will receive chemotherapy and tamoxifen as in group three plus octreotide as in group two. Patients who have undergone lumpectomy will receive radiation therapy.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

National Surgical Adjuvant Breast and Bowel Project

Richard Margolese, MD, Protocol chair		Ph: 514-342-3504

Registry Information
Official Title		A Clinical Trial to Evaluate the Benefit of Adding Octreotide (SMS 201-995 PA LAR) to Tamoxifen Alone or to Tamoxifen and Chemotherapy in Patients With Axillary Node-Negative, Estrogen-Receptor-Positive, Primary Invasive Breast Cancer
Trial Start Date		1997-05-01
Registered in ClinicalTrials.gov		NCT00002967
Date Submitted to PDQ		1997-05-01
Information Last Verified		2006-11-09
NCI Grant/Contract Number		U10-CA12027

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