Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, OtherCDR0000672523
ECOG-E3108, E3108, NCT01124695

Trial Description

Summary

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.

Further Study Information

OBJECTIVES:

Primary

  • To correlate CYP2D6 score (0 vs 1-2) and progression-free survival (PFS) of patients with metastatic breast cancer treated with tamoxifen citrate.

Secondary

  • To correlate CYP2D6 score (0 vs 1 vs 2) and PFS of patients treated with this regimen.
  • To correlate CYP2D6 score (0 vs 1 + 2) and the proportion of these patients who are PFS at 6 months.
  • To correlate endoxifen concentration with response in patients treated with this regimen.
  • To correlate CYP2D6 with response in patients treated with this regimen.
  • To correlate the presence of candidate estrogen receptor (ESR) 1 and 2 variant alleles, UGT7, SULT1A1, and other candidate genes to PFS.

OUTLINE: This is a multicenter study.

Patients receive oral tamoxifen citrate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.

Blood, plasma, and tissue samples are collected periodically for laboratory studies.

After completion of study therapy, patients are followed up every 3-6 months for 5 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • 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
  • Receptor testing on metastatic disease is not required
  • Measurable or non-measurable disease
  • History of 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
  • No known leptomeningeal disease allowed

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Menopausal status not specified
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases present)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, assessment of response, or anticipated toxicities
  • More than 5 years since prior invasive malignancies except curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior investigational agents in the metastatic setting
  • Other prior investigational agents in any setting must have been completed at least 6 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
  • Prior tamoxifen for advanced disease is not allowed
  • No prior chemotherapy or trastuzumab (Herceptin) for metastatic disease
  • Prior chemotherapy, trastuzumab, or bevacizumab in the adjuvant setting allowed provided it has been completed ≥ 4 weeks before study therapy
  • Patients must not have had more than 2 lines of non-hormonal treatment in the locally advanced or metastatic setting, including trastuzumab (Herceptin), bevacizumab, or other biologics
  • 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)
  • Patients may not initiate 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
  • 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
  • Recovered from prior radiotherapy
  • No other concurrent hormonal therapy
  • No concurrent chemotherapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

  • National Cancer Institute
Vered Stearns, Principal Investigator

Trial Sites

U.S.A.

Illinois
La Grange

La Grange Memorial Hospital

Renee H. Jacobs
Ph: 630-856-7526

Springfield

Regional Cancer Center at Memorial Medical Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Massachusetts
Boston

Tufts Medical Center Cancer Center

John K. Erban
Ph: 617-636-5000
Email: ContactUsCancerCenter@TuftsMedicalCenter.org

Minnesota
Fergus Falls

Lake Region Healthcare Corporation-Cancer Care

Preston D. Steen
Ph: 701-234-6161

North Dakota
Bismarck

Bismarck Cancer Center

John T Reynolds
Ph: 701-323-5760
Email: tfischer@mohs.org

Ohio
Akron

McDowell Cancer Center at Akron General Medical Center

Esther H. Rehmus
Ph: 330-344-6348

Pennsylvania
Media

Riddle Memorial Hospital Cancer Center

Allison Zibelli
Ph: 215-955-6084

Virginia
Charlottesville

Martha Jefferson Hospital Cancer Care Center

Robert S. Pritchard
Ph: 434-654-8400

Wisconsin
Milwaukee

Froedtert Hospital and Medical College of Wisconsin

Timothy S Fenske
Ph: 414-805-4380

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01124695
ClinicalTrials.gov processed this data on November 12, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.