Tamoxifen Response by CYP2D6 Genotype-Based Treatment in Patients with Metastatic or Recurrent Breast Cancer
Not Applicable
Completed
- Conditions
- Hormone receptor-positive metastatic or recurrent breast cancer
- Registration Number
- JPRN-UMIN000009155
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
Between December 2012 and July 2016, 186 patients were enrolled in Japan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 186
Inclusion Criteria
Not provided
Exclusion Criteria
1) HER2 status positive 2) Prior endocrine therapy for recurrent or metastatic disease 3) Prior chemotherapy for recurrent or metastatic disease 4) Patients having active double cancer 5) Patients having CNS metastasis 6) Patients receiving continuous systemic administration of steroids 7) Patients receiving prohibited concomitant medications 8) Patients having difficulty to enroll to the study for psychiatric reasons 9) Patients who are pregnant (or might be pregnant), nursing, or those who will not use contraceptive methods 10) Other cases determined as being unsuitable by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free rate at 6 months after the patient randomization
- Secondary Outcome Measures
Name Time Method 1) Response rate (CR+PR) 2) Clinical benefit (CR+PR + SD for longer than 6 months) 3) Relationship between trough levels of tamoxifen, endoxifen, 4-hydroxytamoxifen and N-desmethyltamoxifen at steady state and efficacy and/or adverse reactions 4) Exploration of factors affecting the response