No registrations found.
ID
Source
Brief title
Health condition
primary hormone receptor positive breast cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
nvt
Study objective
Can absolute AMH levels, measured before start of (neo)adjuvant chemotherapy, correctly predict recovery of ovarian function within the first two years following (neo)adjuvant chemotherapy in pre/perimenopausal patients with early breast cancer?
Study design
nvt
Intervention
no intervention
A. Jager
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
Tel 010 704 17 33
a.jager@erasmusmc.nl
A. Jager
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
Tel 010 704 17 33
a.jager@erasmusmc.nl
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:
• 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5343 |
| NTR-old | NTR5575 |
| Other | Erasmus Medical Center : MEC13-156 |