Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer

Tracking Information
First Submitted Date ICMJE	May 14, 2010
First Posted Date ICMJE	May 17, 2010
Last Update Posted Date	December 7, 2012
Study Start Date ICMJE	September 2010
Estimated Primary Completion Date	July 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 14, 2010)	Correlation between CYP2D6 score (0 vs 1-2) and progression-free survival (PFS)
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01124695 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 14, 2010)	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
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer
Official Title ICMJE	A Phase II Prospective Trial Correlating Progression Free Survival With CYP2D6 Activity in Patients With Metastatic Breast Cancer Treated With Single Agent Tamoxifen
Brief 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.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Breast Cancer
Intervention ICMJE	Drug: tamoxifen citrate; Other: laboratory biomarker analysis
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: May 14, 2010)	240
Original Estimated Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Estimated Primary Completion Date	July 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada, Peru, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01124695
Other Study ID Numbers ICMJE	CDR0000672523; ECOG-E3108
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Robert L. Comis, ECOG Group Chair's Office
Study Sponsor ICMJE	Eastern Cooperative Oncology Group
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Principal Investigator: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account	National Cancer Institute (NCI)
Verification Date	December 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP