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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01272037 |
Purpose
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer.
PURPOSE: This phase III clinical trial is studying how well giving tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy works in treating patients with invasive breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: anastrozole Drug: exemestane Drug: letrozole Drug: systemic chemotherapy Drug: tamoxifen citrate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and Her2-Negative Breast Cancer With Recurrence Score (RS) of 25 or Less |
| Estimated Enrollment: | 4000 |
| Study Start Date: | January 2011 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive a protocol-approved chemotherapy regimen based on the patient and/or physician preference. Patients then receive a protocol-approved adjuvant endocrine therapy comprising tamoxifen citrate, an aromatase inhibitor (anastrozole, letrozole, or exemestane), or both for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
Drug: anastrozole
Given orally
Drug: exemestane
Given orally
Drug: letrozole
Given orally
Drug: systemic chemotherapy
Given intravenously
Drug: tamoxifen citrate
Given orally
|
|
Active Comparator: Arm II
Patients receive a protocol-approved endocrine therapy comprising tamoxifen citrate, an aromatase inhibitor (anastrozole, letrozole, or exemestane), or both for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
Drug: anastrozole
Given orally
Drug: exemestane
Given orally
Drug: letrozole
Given orally
Drug: tamoxifen citrate
Given orally
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to Recurrence Score (0-13 vs 14-25), menopausal status (pre-menopausal vs post-menopausal), and type of nodal dissection (axillary lymph node dissection [with or without sentinel node mapping] vs sentinel node biopsy without axillary lymph node dissection). Patients are randomized to 1 of 2 treatment arms.
Patients may complete health-related quality-of-life (QOL) questionnaires at baseline and periodically during study. Information on Medicare and/or insurance coverage and on health-coverage decisions may also be collected periodically.
After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for at least 15 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer meeting the following criteria:
1-3 node-positive disease (pN1mi, pN1a, pN1b, or pN1c) by sentinel node biopsy or axillary lymph node dissection
Positive estrogen receptor (ER) and/or progesterone receptor (PR) status according to American Society of Clinical Research/College of American Pathologists (ASCO/CAP) guidelines
Negative HER-2 as determined by IHC or non-amplified fluorescence in situ hybridization (FISH) or chromogen in situ hybridization (CISH) for screening
Recurrence Score (RS) by Oncotype DX® ≤ 25
Patients with multifocal, multicentric, or synchronous bilateral breast cancers are allowed
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations
Show 688 Study Locations| Principal Investigator: | Ana M. Gonzalez-Angulo, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT01272037 History of Changes |
| Other Study ID Numbers: | CDR0000692475, SWOG-S1007 |
| Study First Received: | January 6, 2011 |
| Last Updated: | February 7, 2012 |
| Health Authority: | Unspecified |
|
estrogen receptor-positive breast cancer HER2-negative breast cancer progesterone receptor-positive breast cancer stage II breast cancer |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Citric Acid Tamoxifen Anastrozole Exemestane Letrozole Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
Chelating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists Aromatase Inhibitors Enzyme Inhibitors |