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ACTIVE NOT RECRUITING
NCT02311933
PHASE2

Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This randomized phase II trial studies how well tamoxifen citrate works compared with z-endoxifen hydrochloride in treating patients with breast cancer that has spread to nearby tissue or lymph nodes or other parts of the body and has estrogen receptors but not human epidermal growth factor receptor 2 (HER2) receptors on the surface of its cells. Estrogen can cause the growth of tumor cells. Hormone therapy using tamoxifen citrate or z-endoxifen hydrochloride may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether tamoxifen citrate or z-endoxifen hydrochloride is more effective in treating patients with breast cancer.

Official title: A Randomized Phase II Trial of Tamoxifen Versus Z-Endoxifen HCL in Postmenopausal Women With Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

81

Start Date

2015-05-28

Completion Date

2027-02-02

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

DRUG

Endoxifen Hydrochloride

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

DRUG

Tamoxifen Citrate

Given PO

Locations (559)

Southern Cancer Center PC-Providence

Mobile, Alabama, United States

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Alaska Regional Hospital

Anchorage, Alaska, United States

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Anchorage Oncology Centre

Anchorage, Alaska, United States

Katmai Oncology Group

Anchorage, Alaska, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

Kaiser Permanente-Anaheim

Anaheim, California, United States

PCR Oncology

Arroyo Grande, California, United States

Sutter Auburn Faith Hospital

Auburn, California, United States

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, United States

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, California, United States

Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

Kaiser Permanente-Bellflower

Bellflower, California, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Mills-Peninsula Medical Center

Burlingame, California, United States

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

Eden Hospital Medical Center

Castro Valley, California, United States

Sutter Davis Hospital

Davis, California, United States

Epic Care-Dublin

Dublin, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

Kaiser Permanente-Fontana

Fontana, California, United States

Kaiser Permanente South Bay

Harbor City, California, United States

Kaiser Permanente-Irvine

Irvine, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Kaiser Permanente West Los Angeles

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Mercy Cancer Center

Merced, California, United States

Memorial Medical Center

Modesto, California, United States

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Palo Alto Medical Foundation-Gynecologic Oncology

Mountain View, California, United States

Sutter Cancer Research Consortium

Novato, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Hematology and Oncology Associates-Oakland

Oakland, California, United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Kaiser Permanente - Panorama City

Panorama City, California, United States

Kaiser Permanente-Riverside

Riverside, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Sutter Roseville Medical Center

Roseville, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Kaiser Permanente-Rio San Diego

San Diego, California, United States

Kaiser Permanente-San Diego Zion

San Diego, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Kaiser Permanente-San Marcos

San Marcos, California, United States

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, United States

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Kaiser Permanente-Woodland Hills

Woodland Hills, California, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

AdventHealth Porter

Denver, Colorado, United States

CommonSpirit Cancer Center Mercy

Durango, Colorado, United States

Mercy Medical Center

Durango, Colorado, United States

Mountain Blue Cancer Care Center

Golden, Colorado, United States

CommonSpirit Saint Anthony Hospital Cancer Center

Lakewood, Colorado, United States

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, United States

AdventHealth Littleton

Littleton, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, United States

AdventHealth Parker

Parker, Colorado, United States

Rocky Mountain Cancer Centers-Parker

Parker, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Rocky Mountain Cancer Centers - Pueblo

Pueblo, Colorado, United States

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Middlesex Hospital

Middletown, Connecticut, United States

Halifax Health Cancer Center for Hope - Daytona Beach

Daytona Beach, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

University Cancer and Blood Center LLC

Athens, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

Northside Hospital-Forsyth

Cumming, Georgia, United States

Emory Decatur Hospital

Decatur, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, United States

Island Urology

Honolulu, Hawaii, United States

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, United States

Queen's Medical Center

Honolulu, Hawaii, United States

Straub Clinic and Hospital

Honolulu, Hawaii, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Hawaii Cancer Care Inc-Liliha

Honolulu, Hawaii, United States

Kuakini Medical Center

Honolulu, Hawaii, United States

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

And 459 more locations on ClinicalTrials.gov