Hormone Therapy in Treating Postmenopausal Women With Receptor-Positive Breast Cancer

Recruiting in Palo Alto (17 mi)

+84 other locations

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eastern Cooperative Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining chemotherapy with hormone therapy may kill more tumor cells. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of fenretinide may be an effective way to prevent the recurrence of breast cancer. It is not yet known whether tamoxifen plus fenretinide is more effective than tamoxifen alone for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen plus fenretinide with tamoxifen alone in treating postmenopausal women who have stage II or stage III breast cancer that is estrogen receptor positive and/or progesterone receptor positive.

Research Team

Melody A. Cobleigh, MD

Principal Investigator

Rush University Medical Center

Mark L. Graham, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

James N. Ingle, MD

Principal Investigator

Mayo Clinic

George Thomas Budd, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast Pathologic stage T1-3, N1-2, M0 No clinical or pathologic T4 disease No primary tumor fixed to chest wall No axillary nodes fixed to chest wall or neurovascular bundle No preoperative arm edema No clinical skin involvement (microscopic focal dermal invasion or dermal lymphatic involvement eligible) No clinical N2 disease Modified radical mastectomy or lumpectomy required prior to entry Sentinel node biopsy allowed Randomization required within 12 weeks from definitive surgery Surgery dated from mastectomy or axillary dissection for lumpectomy No positive deep mastectomy margins Radiotherapy planned within 12 weeks following axillary node dissection for lumpectomy patients Synchronous bilateral breast cancer eligible If tumor is at least 2 cm, then nodes not involved If no tumor is at least 2 cm, then at least 1 node must be involved Both invasive primaries receptor-positive Previously treated, noninvasive breast cancer eligible No prior invasive breast cancer No adenoid cystic, squamous, or sarcomatous histology Hormone receptor status: Estrogen- or progesterone-receptor positive, i.e.: At least 10 fmole/mg cytosol protein by ligand-binding assay OR Receptor positive by immunocytochemistry

PATIENT CHARACTERISTICS: Age: 65 and over OR Postmenopausal and ineligible/inappropriate for or declined other active node positive adjuvant studies Sex: Female Menopausal status: Postmenopausal, defined as: At least 1 year since last menstrual period Hysterectomized with bilateral oophorectomy Hysterectomized with 1 or both ovaries remaining and either: Over 60 FSH in postmenopausal range Not surgically castrated, under 60, and on HRT FSH elevated 2 weeks after HRT discontinued Performance status: Not specified Life expectancy: At least 7 years except for breast cancer Hematopoietic: WBC greater than 3,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL AST less than 2 times normal Renal: Creatinine no greater than 2.0 mg/dL BUN no greater than 25.0 mg/dL Other: No extensive macular degeneration on exam within 1 year of entry, e.g.: No exudative or atrophic macular lesions that reduce corrected vision to less than 20/40 Health adequate for protocol treatment No nutritional supplementation except single daily multivitamin No other vitamin A supplements Gynecologic exam within the past year required of women who retain a uterus No second malignancy within the past 10 years except: Inactive nonmelanomatous skin cancer Carcinoma in situ of the cervix Prior noninvasive contralateral breast cancer

PRIOR CONCURRENT THERAPY: No prior chemotherapy or hormonal therapy for breast cancer except: Up to 1 month of tamoxifen if started by a non participating physician At least 2 weeks since hormone replacement therapy No concurrent megestro

Treatment Details

Interventions

• Fenretinide (Chemoprevention Therapy)
• Tamoxifen (Hormone Therapy)

Tamoxifen is already approved in Canada, Japan for the following indications:

Approved in Canada as Tamoxifen for:

• Breast cancer
• Reduction in breast cancer incidence in high-risk women

Approved in Japan as Tamoxifen for:

• Breast cancer

Who Is Running the Clinical Trial?

Eastern Cooperative Oncology Group

Lead Sponsor

Trials

272

Recruited

153,000+

Dr. Mitchell D. Schnall

Eastern Cooperative Oncology Group

Chief Medical Officer

MD, PhD from University of Pennsylvania

Dr. Peter J. O'Dwyer

Eastern Cooperative Oncology Group

Chief Executive Officer

MD from University of Pennsylvania

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

SWOG Cancer Research Network

Collaborator

Trials

403

Recruited

267,000+

Dr. Charles D. Blanke

SWOG Cancer Research Network

Chief Executive Officer since 2012

MD from Oregon Health & Science University

Dr. Dawn Hershman

SWOG Cancer Research Network

Chief Medical Officer since 2020

MD from Columbia University

Cancer and Leukemia Group B

Collaborator

Trials

81

Recruited

118,000+

Dr. Richard L. Schilsky

Cancer and Leukemia Group B

Chief Executive Officer since 2012

MD from University of Chicago

Dr. Walter Stadler

Cancer and Leukemia Group B

Chief Medical Officer since 2012

MD from Harvard Medical School

North Central Cancer Treatment Group

Collaborator

Trials

49

Recruited

81,100+

Southwest Oncology Group

Collaborator

Trials

389

Recruited

260,000+

Dr. Lyudmila Bazhenova

Southwest Oncology Group

Chief Medical Officer since 2021

MD from University of California, San Diego

Dr. Richard Schilsky

Southwest Oncology Group

Chief Executive Officer since 2013

MD from University of California, San Diego