primary hormone receptor positive breast cancer
Conditions
Interventions
no intervention
Sponsors
none
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: • Primary hormone-sensitive (ER >10% positive and/or PgR >10% positive) breast cancer, independent of Her2- receptor status, curatively locally treated • Age 46 years • Indication for (neo-)adjuvant chemotherapy according to the Dutch Guidelines for breast cancer treatment (2012) • Pre- (regular menstrual cyclicity) and perimenopausal women (amenorrhea duration of less than 12 months) before the start of (neo-) adjuvant chemotherapy
Exclusion criteria
Exclusion criteria: Exclusion criteria: • Bilateral oophorectomy • History of hysterectomy (no information on menstrual cycle possible) • Evidence of distant metastases • Use of GnRH agonists within 12 months before the start of (neo-) adjuvant chemotherapy • Use of hormone-containing intra-uterine device (Mirena®), irrespective of age at breast cancer diagnosis (use of copper-containing devices is allowed) • Chemotherapy prior to inclusion in the study • Use of aromatase inhibitors or tamoxifen <6 months before start of (neo-) adjuvant chemotherapy • History of pelvic radiatiotherapy • History of treatment with cytotoxic chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recovery of ovarian function is defined as resumption of menstrual cyclicity (at least more than 1 episode of vaginal bleeding, not caused by vaginal atrophy) and/or levels of estradiol and FSH in the postmenopausal range (according to the local laboratory values; in general >110 pmol/l and <20 pmol/l, respectively), being reconfirmed at least once. | — |
Contacts
Public ContactA. Jager
Erasmus MC, Room 471
Outcome results
None listed