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The protective effect of tamoxifen in women with ER-positive breast cancer who opt for cryopreservation of oocytes or embryos: a prospectively controlled study.

The protective effect of tamoxifen in women with ER-positive breast cancer who opt for cryopreservation of oocytes or embryos: a prospectively controlled study. - Tamoxi-study

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36860
Enrollment
40
Registered
2013-03-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer mammary carcinoma

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Number of women who reach a serum endoxifen above the threshold level of 5.9 ng/ml during COS.—

Secondary

MeasureTime frame
Secundary parameters are: - Levels of serum tamoxifen metabolites in the course of ovarian stimulation. - Estradiol levels in the course of ovarian stimulation. - Number of oocytes or embryo*s retrieved and cryopreserved after ovarian stimulation. - Ongoing pregnancy rate. - Breast cancer recurrence free survival after 60 and 120 months.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)