The protective effect of tamoxifen in women with ER-positive breast cancer who opt for cryopreservation of oocytes or embryos: a prospectively controlled study.
Withdrawn
- Conditions
- breast cancermammary carcinoma1000629110018515
- Registration Number
- NL-OMON36860
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Age 18 * 43 years
Confirmed ER-positive breast cancer
Candidate for (neo) adjuvant chemotherapy
Opting for embryo or oocyte cryopreservation
Willing and able to give informed consent
Exclusion Criteria
Contraindication to tamoxifen use
Use of medication that opposes the effect of study medication
Pregnancy or lactation
Recent chemotherapy
Liver- or kidney failure
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Number of women who reach a serum endoxifen above the threshold level of 5.9<br /><br>ng/ml during COS.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary parameters are:<br /><br>- Levels of serum tamoxifen metabolites in the course of ovarian stimulation.<br /><br>- Estradiol levels in the course of ovarian stimulation.<br /><br>- Number of oocytes or embryo*s retrieved and cryopreserved after ovarian<br /><br>stimulation.<br /><br>- Ongoing pregnancy rate.<br /><br>- Breast cancer recurrence free survival after 60 and 120 months.</p><br>