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COMPLETED

NCT00066690

PHASE3

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

Sponsor: ETOP IBCSG Partners Foundation

View on ClinicalTrials.gov

Summary

RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer. PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.

Official title: A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

3066

Start Date

2003-12-17

Completion Date

2024-11-06

Last Updated

2026-08-26

Healthy Volunteers

Conditions

Estrogen Receptor Positive Breast Cancer Progesterone Receptor Positive Tumor Recurrent Breast Carcinoma Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA Breast Cancer

Interventions

DRUG

Exemestane

Exemestane 25mg orally daily for 5 years plus ovarian function suppression

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Oophorectomy

Undergo bilateral surgical oophorectomy

OTHER

Quality-of-Life Assessment

Ancillary studies

RADIATION

Radiation Therapy

Undergo ovarian irradiation

DRUG

Tamoxifen

Tamoxifen 20mg orally daily for 5 years

DRUG

Triptorelin

3.75 mg by im injection q28 days for 5 years

Inclusion Criteria: * Premenopausal women (estradiol \[E2\] in the premenopausal range \[according to institution parameters\]) who meet the following criteria: * Patients who did not receive chemotherapy should be randomized within 12 weeks after definitive surgery; such patients should have estradiol (E2) in the premenopausal range following surgery; the only patients who do not require testing of estradiol (E2) to confirm premenopausal status are those who have been menstruating regularly during the 6 months prior to randomization and have not used any form of hormonal contraception or any other hormonal treatments during the 6 months prior to randomization * Patients who received prior adjuvant and/or neoadjuvant chemotherapy should be randomized after completing chemotherapy and within 8 months of the final dose of chemotherapy as soon as premenopausal status is confirmed; all such patients should have premenopausal status confirmed by an estradiol (E2) in the premenopausal range between 2 weeks and 8 months after completing chemotherapy * Adjuvant trastuzumab (Herceptin ®) is allowable, and is not considered to be chemotherapy for eligibility timing determination * Patients with temporary chemotherapy-induced amenorrhea who regain premenopausal status within eight months of the final dose of chemotherapy are eligible; (please note that some patients taking tamoxifen or aromatase inhibitors, even without evidence of menses, may have ovarian function recovery following chemotherapy and resume estradiol secretion); in patients wishing to participate in the study, with postmenopausal hormone levels shortly after chemotherapy, it is recommended to recheck their estradiol level at a later timepoint within 8 months of completing chemotherapy, even in the absence of return of menses * Histologically proven, resected breast cancer; pathology material should be available for submission for central review as part of the quality control measures for this protocol * Patients must have hormone receptor positive tumors; if there is more than one breast tumor, each tumor must be hormone receptor positive; hormone receptors must be determined using immunohistochemistry; estrogen receptor (ER) and/or progesterone receptor (PgR) must be greater than or equal to 10% of the tumor cells positive by immunohistochemical evaluation; biochemical determination alone is not acceptable * The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere, with the exception of tumor detected in internal mammary chain nodes by sentinel node procedure; patients who received neoadjuvant therapy must have had operable disease prior to neoadjuvant treatment to be eligible; patients who had a pathological evaluation with tru cut or core biopsy of invasive breast cancer prior to neoadjuvant therapy and were found to have no invasive tumor in the pathological specimen from definitive surgery are eligible; for these patients, pre-neoadjuvant tumor characteristics will be used for defining eligibility; in case of persistent disease, pathology findings from the definitive surgery should be used * Patients must have had proper surgery for primary breast cancer with no known clinical residual loco-regional disease: * A total mastectomy; radiotherapy is optional after mastectomy OR * A breast-conserving procedure (lumpectomy, quadrantectomy or partial mastectomy with margins clear of invasive cancer and ductal breast carcinoma in situ \[DCIS\]); the local pathologist must document negative margins of resection in the pathology report; if all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed; likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed; radiation therapy to the conserved breast is required; patients may be randomized before, during or after completion of radiation therapy to the breast * Either axillary lymph node dissection (pathological examination of at least 6 nodes recommended) or a negative axillary sentinel node biopsy (pN0\[sn\]) is required; patients with negative or microscopically axillary positive sentinel nodes (pN1mi: micrometastasis none \> 2.0 mm) do not require further axillary therapy; those with positive sentinel nodes must have either an axillary dissection or radiation of axillary nodes * For International Breast Cancer Study Groups (IBCSG) centers, patients must have completed baseline Quality of Life (QL) Forms prior to randomization; the only exceptions are cognitive or physical impairment that interferes with QL assessment or inability to read any of the languages available on IBCSG QL forms; for non-IBCSG centers, extent of participation in the QL study is to be determined at the activation of the trial for each cooperative group * Written informed consent must be signed and dated by the patient and the investigator prior to randomization * Patients must be accessible for follow-up * Patients must be informed of and agree to data and tissue material transfer and handling, in accordance with national data protection guidelines Exclusion Criteria: * Patients who are postmenopausal (i.e., do not have an estradiol \[E2\] level in the premenopausal range) after surgery or after chemotherapy, whichever is later * Patients with distant metastatic disease * Patients with locally advanced inoperable breast cancer including inflammatory breast cancer or supraclavicular node involvement or with enlarged internal mammary nodes (unless pathologically negative) are not eligible; patients with involved internal mammary nodes detected by sentinel node biopsy that are not enlarged are eligible * Patients with positive final margins (referring to only DCIS and invasive cancer, not lobular breast carcinoma in situ \[LCIS\]), except as noted; DCIS at a margin is permitted if a complete mastectomy has been performed * Patients with clinically detectable residual axillary disease * Patients with a history of prior ipsilateral or contralateral invasive breast cancer; patients with synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) are eligible if the bilateral disease meets all other eligibility criteria * Patients with previous or concomitant invasive malignancy are not eligible; the exceptions are patients with the following (and only the following) malignancies (previous or concomitant) who are eligible if adequately treated: * Basal or squamous cell carcinoma of the skin * In situ non-breast carcinoma without invasion * Contra- or ipsilateral in situ breast carcinoma * Non-breast invasive malignancy diagnosed at least 5 years ago and without recurrence: * Stage I papillary thyroid cancer * Stage Ia carcinoma of the cervix * Stage Ia or b endometrioid endometrial cancer * Borderline or stage I ovarian cancer * Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung, etc.) that would prevent prolonged follow-up; patients with previous thrombosis (e.g., deep vein thrombosis \[DVT\]) and/or embolism can be included only if medically suitable * Patients who have had a bilateral oophorectomy or ovarian irradiation; patients who will be recommended to undergo oophorectomy within 5 years (e.g., breast cancer susceptibility gene \[BRCA\]1/2 gene carriers) and therefore for whom randomization to a treatment arm without OFS is inappropriate * Patients with a history of noncompliance to medical regimens and patients who are considered potentially unreliable * Patients who are pregnant or lactating at the time of randomization or who desire a pregnancy within 5 years; patients planning to use additional hormonal therapy apart from the randomized treatment during the next five years including all types of hormonal contraception; a pregnancy test is recommended for women of child-bearing potential who are sexually active and not using reliable contraceptive methods * Patients who received endocrine therapy (including neoadjuvant and adjuvant) for more than 8 months after their breast cancer diagnosis; patients who are receiving endocrine therapy at randomization (and have received it for less than 8 months) may continue such therapy until protocol-specified tamoxifen/exemestane is initiated * Patients who were taking tamoxifen or other selective estrogen receptor modulator (SERM) (e.g. Raloxifene) or hormone replacement therapy (HRT) within one year prior to their breast cancer diagnosis; prior oral contraceptives are allowed * Patients who have received GnRH analogues as part of their breast cancer treatment prior to randomization * Patients with psychiatric, addictive, or any disorder that would prevent compliance with protocol requirements

Locations (500)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Mills - Peninsula Hospitals

Burlingame, California, United States

East Bay Radiation Oncology Center

Castro Valley, California, United States

Valley Medical Oncology Consultants-Castro Valley

Castro Valley, California, United States

John Muir Medical Center-Concord Campus

Concord, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Valley Medical Oncology Consultants-Fremont

Fremont, California, United States

Glendale Memorial Hospital and Health Center

Glendale, California, United States

Marin General Hospital

Greenbrae, California, United States

Scripps Cancer Center

La Jolla, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Memorial Medical Center

Modesto, California, United States

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Sutter Cancer Research Consortium

Novato, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Hematology and Oncology Associates-Oakland

Oakland, California, United States

Tom K Lee Inc

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

Valley Medical Oncology Consultants

Pleasanton, California, United States

Eisenhower Medical Center

Rancho Mirage, California, United States

Mercy Regional Cancer Center

Redding, California, United States

Kaiser Permanente-Redwood City

Redwood City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

Mercy General Hospital

Sacramento, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Kaiser Permanente - Sacramento

Sacramento, California, United States

Salinas Valley Memorial

Salinas, California, United States

University of California San Diego

San Diego, California, United States

Kaiser Permanente-San Diego Mission

San Diego, California, United States

Veterans Administration-San Diego Medical Center

San Diego, California, United States

San Francisco General Hospital

San Francisco, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

UCSF Medical Center-Mount Zion

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Kaiser Permanente-San Rafael

San Rafael, California, United States

Santa Rosa Memorial Hospital

Sana Rosa, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

John Muir Medical Center-Walnut Creek

Walnut Creek, California, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Boulder Community Hospital

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Memorial Hospital Colorado Springs

Colorado Springs, Colorado, United States

Denver Health Medical Center

Denver, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

SCL Health Saint Joseph Hospital

Denver, Colorado, United States

Denver Veterans Administration Medical Center

Denver, Colorado, United States

Rose Medical Center

Denver, Colorado, United States

Colorado Cancer Research Program NCORP

Denver, Colorado, United States

The Shaw Regional Cancer Center

Edwards, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Front Range Cancer Specialists

Fort Collins, Colorado, United States

North Colorado Medical Center

Greeley, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

North Suburban Medical Center

Thornton, Colorado, United States

SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Norwalk Hospital

Norwalk, Connecticut, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Stamford Hospital/Bennett Cancer Center

Stamford, Connecticut, United States

Charlotte Hungerford Hospital Center for Cancer Care

Torrington, Connecticut, United States

Bayhealth Medical Center at Kent General

Dover, Delaware, United States

Beebe Medical Center

Lewes, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Nanticoke Memorial Hospital

Seaford, Delaware, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Cancer Research Network Inc

Boca Raton, Florida, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Jupiter Medical Center

Jupiter, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Florida Cancer Specialists - Sarasota Downtown

Sarasota, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

Emory University/Winship Cancer Institute

Atlanta, Georgia, United States

Atlanta Regional CCOP

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, United States

Augusta Oncology Associates PC-Saint Sebastian

Augusta, Georgia, United States

Well Star Cobb Hospital

Austell, Georgia, United States

John B Amos Cancer Center

Columbus, Georgia, United States

Dekalb Medical Center

Decatur, Georgia, United States

Gwinnett Medical Center

Lawrenceville, Georgia, United States

Wellstar Kennestone Hospital

Marietta, Georgia, United States

Southern Regional Medical Center

Riverdale, Georgia, United States

Harbin Clinic Medical Oncology and Clinical Research

Rome, Georgia, United States

Memorial University Medical Center

Savannah, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Tripler Army Medical Center

Honolulu, Hawaii, United States

Saint Joseph Medical Center

Bloomington, Illinois, United States

Graham Hospital Association

Canton, Illinois, United States

Memorial Hospital

Carthage, Illinois, United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Weiss Memorial Hospital

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Heartland Cancer Research NCORP

Decatur, Illinois, United States

Eureka Hospital

Eureka, Illinois, United States

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Mason District Hospital

Havana, Illinois, United States

Hopedale Medical Complex - Hospital

Hopedale, Illinois, United States

Kewanee Hospital

Kewanee, Illinois, United States

Mcdonough District Hospital

Macomb, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Edward Hospital/Cancer Center

Naperville, Illinois, United States

Bromenn Regional Medical Center

Normal, Illinois, United States

Community Cancer Center Foundation

Normal, Illinois, United States

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

Pekin, Illinois, United States

Pekin Hospital

Pekin, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Proctor Hospital

Peoria, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Illinois Valley Hospital

Peru, Illinois, United States

Valley Radiation Oncology

Peru, Illinois, United States

Perry Memorial Hospital

Princeton, Illinois, United States

OSF Saint Anthony Medical Center

Rockford, Illinois, United States

Sarah Culbertson Memorial Hospital

Rushville, Illinois, United States

Saint Margaret's Hospital

Spring Valley, Illinois, United States

Memorial Medical Center

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Elkhart General Hospital

Elkhart, Indiana, United States

Fort Wayne Medical Oncology and Hematology Inc-Parkview

Fort Wayne, Indiana, United States

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, United States

Community Hospital East

Indianapolis, Indiana, United States

Community Regional Cancer Care-North

Indianapolis, Indiana, United States

Saint Vincent Hospital and Health Care Center

Indianapolis, Indiana, United States

IU Health La Porte Hospital

La Porte, Indiana, United States

IU Health Arnett Cancer Care

Lafayette, Indiana, United States

Horizon Oncology Center

Lafayette, Indiana, United States

Saint Joseph Regional Medical Center - Mishawaka

Mishawaka, Indiana, United States

Memorial Hospital of South Bend

South Bend, Indiana, United States

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, United States

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, United States

Saint Luke's Hospital

Cedar Rapids, Iowa, United States

Mercy Hospital

Cedar Rapids, Iowa, United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, United States

Genesis Medical Center - East Campus

Davenport, Iowa, United States

Mercy Capitol