Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer, Stage IV Breast Cancer

In brief

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight cancer by blocking the use of estrogen by tumor cells. PURPOSE: This phase II trial is studying how well tamoxifen citrate works in patients with metastatic or recurrent breast cancer.

Key facts

Study ID

NCT01124695

Run by

ECOG-ACRIN Cancer Research Group

People needed

124

Starts

2011-01-07

Expected to finish

2022-12-01

Last updated by the study team

2023-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed adenocarcinoma of the breast
• Stage III (locally advanced), metastatic, or recurrent disease
• Deemed not resectable
• Estrogen-receptor and/or progesterone-receptor positive disease
• Receptor status is based on most recent results
• Measurable or non-measurable disease
• ECOG performance status 0-2
• History of central nervous system (CNS) metastasis allowed provided it has been treated (surgery, radiotherapy, or radiosurgery) within the past 4 weeks and does not require medications to control symptoms
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases present)
• Negative pregnancy test
• Fertile patients must use effective nonhormonal contraception
• Disease-free of prior invasive malignancies for ≥ 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
• Prior chemotherapy, trastuzumab, or bevacizumab in the adjuvant setting allowed provided it has been completed ≥ 4 weeks before study therapy; other prior non-hormonal investigational agents in the adjuvant setting must have been completed at least 4 weeks prior to study registration and should be discussed with the study PI
• Prior tamoxifen as adjuvant treatment is allowed as long as the patient did not have disease relapse or progression while on adjuvant tamoxifen or within 4 weeks of last dose
• Treatment in the advanced setting must have been completed at least 2 weeks prior to study initiation
• Prior aromatase inhibitors (e.g., anastrozole, letrozole, exemestane, aminoglutethamide) are allowed in the adjuvant or metastatic setting
• At least 2 weeks since prior and no concurrent medications that are strong to moderate inhibitors of CYP2D6 and may alter tamoxifen citrate metabolism including, but not limited to, any of the following:
• Paroxetine (Paxil)
• Fluoxetine (Prozac)
• Bupropion (Wellbutrin)
• Quinidine (Cardioquin)
• Concurrent radiotherapy to painful sites of bone disease or areas of impending fractures allowed provided the following criteria are met:
• Radiotherapy was initiated before study entry
• Sites of measurable or non-measurable disease are outside the radiotherapy port

You may not qualify if…

• Pregnant or nursing
• Concurrent chemotherapy
• Leptomeningeal disease
• Non-protocol concurrent hormonal therapy
• Medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, assessment of response, or anticipated toxicities
• Prior tamoxifen for advanced disease
• More than 2 lines of non-hormonal treatment in the locally advanced or metastatic setting, including trastuzumab (Herceptin), bevacizumab, or other biologics
• Starting bisphosphonate therapy while receiving treatment on this study
• Patients who have begun receiving bisphosphonate therapy prior to registration may continue at the same intervals used prior to study registration

Where it is running

• University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States
• Hembree Mercy Cancer Center at St. Edward Mercy Medical Center — Fort Smith, Arkansas, United States
• Tibotec Therapeutics - Division of Ortho Biotech Products, LP — Marysville, California, United States
• Mercy Cancer Center at Mercy Medical Center — Merced, California, United States
• Camino Medical Group - Treatment Center — Mountain View, California, United States
• St. Joseph Hospital Regional Cancer Center - Orange — Orange, California, United States
• Palo Alto Medical Foundation — Palo Alto, California, United States
• Valley Medical Oncology Consultants - Pleasanton — Pleasanton, California, United States
• University of California Davis Cancer Center — Sacramento, California, United States
• Tahoe Forest Cancer Center — Truckee, California, United States
• Aurora Presbyterian Hospital — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
• St. Anthony Central Hospital — Denver, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
• St. Joseph Hospital — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• CCOP - Colorado Cancer Research Program — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center — Grand Junction, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Littleton Adventist Hospital — Littleton, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• UAB Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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