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

Phase 2TerminatedNCT02113553

Armando Santoro, MD45 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

TriptorelinDRUG

Triptorelin administered once every 28 days in addition to chemotherapy

Eligibility

Sex: FEMALEMax age: 40 Years

Medical Language ↔ Plain English

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. \- 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.

Locations (1)

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Outcomes

Primary Outcomes

AMH in response to chemotherapy plus GnRHa

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

Time frame: 18 months

Secondary Outcomes

AMH and menstrual cycle

To correlate AMH behaviour with recovery of menstrual cycle (in the ER negative cohort);

Time frame: 18 months

AMH after chemotherapy

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

Time frame: 18 months

AMH levels >0.2 ng/mL at the 12-month time point

Evaluate the proportion of patients with AMH levels \>0.2 ng/mL at the 12-month time point.

Time frame: 18 months

Data from ClinicalTrials.gov

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