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

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Triptorelin

• Registration Number: NCT02113553
• Lead Sponsor: Armando Santoro, MD

Brief 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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-27
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-14
• Primary Completion: 2016-05
• Study Completion: 2016-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

1. Female subjects, aged <40yr at the time of breast cancer diagnosis

2. Diagnosis of operable breast cancer any T and N, any ER

3. Patients candidate to adjuvant chemotherapy for 4-8 cycles.

4. Patients compliant to adhere to all protocol procedures.

5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 28 days prior to the start of the study treatment.

6. Negative pregnancy test at the study enrolment; fertile women must use effective contraception during chemotherapy

7. Patients must be able to understand and sign written informed consent.

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Exclusion Criteria

1. Presence of distant metastasis
2. Clinically significant cardiovascular disease
3. Psychological or social conditions which might affect study compliance
4. Unstable neurologic function
5. Patients with known allergy to any of the components of the study medication
6. Pregnancy or lactation
7. Any condition that, in the opinion of the physician is likely to affect inclusion of the subject into the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triptorelin	Triptorelin	Triptorelin 3.75 administered every 28 days, for 4 to 7 injections depending on the number of cycles of chemotherapy

Primary Outcome Measures

Name	Time	Method
AMH in response to chemotherapy plus GnRHa	18 months	To evaluate AMH levels changes in response to chemotherapy plus GnRHa in order to assess the role of AMH as surrogate marker of the preservation of ovarian reserve exerted by GnRHa

Secondary Outcome Measures

Name	Time	Method
AMH and menstrual cycle	18 months	To correlate AMH behaviour with recovery of menstrual cycle (in the ER negative cohort);
AMH after chemotherapy	18 months	To compare AMH levels obtained at the end of chemotherapy and at 12 months after the end of chemotherapy in the two cohorts of ER positive and ER negative patients
AMH levels >0.2 ng/mL at the 12-month time point	18 months	Evaluate the proportion of patients with AMH levels \>0.2 ng/mL at the 12-month time point.

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milan, Italy