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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Triptorelin

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Istituto Clinico Humanitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 38 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Triptorelin; Triptorelin 3.75 administered every 28 days, for 4 to 7 injections depending on the number of cycles of chemotherapy	Drug: Triptorelin; Triptorelin administered once every 28 days in addition to chemotherapy; Other Names: Decapeptyl; Gonapeptyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AMH and menstrual cycle	To correlate AMH behaviour with recovery of menstrual cycle (in the ER negative cohort);	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	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.	18 months

Collaborators and Investigators

• Sponsor: Armando Santoro, MD

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 27, 2013
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimate): April 14, 2014

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Luteolytic Agents; Triptorelin Pamoate
• Other Study ID Numbers: ONC-2012-002