NCT02113553

Anti-Mullerian Hormone (AMH) as Marker of Ovarian Reserve

ANTI-MULLERIAN HORMONE (AMH) AS A MARKER OF OVARIAN RESERVE IN YOUNG BREAST CANCER PATIENTS RECEIVING CHEMOTHERAPY + GnRH ANALOGUE

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Armando Santoro, MD · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre, prospective study willing to evaluate AMH levels changes in response to chemotherapy plus GnRHa. In the present study we propose to determine AMH levels in breast cancer patients, aged \<40yrs receiving adjuvant chemotherapy and ovarian suppression by means of GnRHa with the aim to assess the role of AMH as surrogate marker of the preservation of ovarian reserve exerted by GnRHa.

Detailed description

Patients will receive 4 to 8 cycles of chemotherapy according to Institutional guidelines. Triptorelin 3.75 will be administered as an intramuscular injection before chemotherapy and every 28 days thereafter for all the duration of chemotherapy in patients with ER negative tumors and for 2 to 5 years in patients with ER positive tumors according to Institutional guidelines. Patients with ER+ve tumour will receive tamoxifen for 5 years at the end of chemotherapy as standard care. A blood sample will be drawn after signed informed consent to determine baseline AMH levels. A blood sample for determination of AMH levels will be collected at the end of chemotherapy and at 12 months after the end of chemotherapy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Triptorelin	Triptorelin administered once every 28 days in addition to chemotherapy

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-05-01
• Completion: 2016-12-01
• First posted: 2014-04-14
• Last updated: 2022-09-10

Locations

1 site across 1 country: Italy