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Clinical Trials (PDQ®)

Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

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 StearnsPrincipal 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
Indiana
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Bryan P Schneider Ph: 317-274-2552
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 Identifer NCT01124695
ClinicalTrials.gov processed this data on October 17, 2013

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.

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