Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01124695
Recruitment Status : Unknown
Verified December 2012 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : May 17, 2010
Last Update Posted : December 7, 2012
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

May 14, 2010
May 17, 2010
December 7, 2012
September 2010
July 2016   (Final data collection date for primary outcome measure)
Correlation between CYP2D6 score (0 vs 1-2) and progression-free survival (PFS)
Same as current
Complete list of historical versions of study NCT01124695 on Archive Site
  • Correlation of CYP2D6 score (0 vs 1 vs 2) with PFS
  • Correlation of CYP2D6 score (0 vs 1-2) with PFS at 6 months
  • Correlation of endoxifen concentration with response
  • Correlation of CYP2D6 with response
Same as current
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Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer
A Phase II Prospective Trial Correlating Progression Free Survival With CYP2D6 Activity in Patients With Metastatic Breast Cancer Treated With Single Agent Tamoxifen

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.



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


  • 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.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: tamoxifen citrate
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
July 2016   (Final data collection date for primary outcome measure)


  • 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


  • 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


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   Peru,   United States
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Robert L. Comis, ECOG Group Chair's Office
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP