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

NCT ID: NCT02113553

Last Updated: 2022-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Triptorelin

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

Group Type: EXPERIMENTAL

Triptorelin

Intervention Type: DRUG

Triptorelin administered once every 28 days in addition to chemotherapy

Interventions

Triptorelin

Triptorelin administered once every 28 days in addition to chemotherapy

Intervention Type: DRUG

Other Intervention Names

Decapeptyl; Gonapeptyl

Eligibility Criteria

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.

• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Armando Santoro, MD

OTHER

Sponsor Role: lead

Responsible Party

Armando Santoro, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Armando Santoro, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Countries

Italy

Other Identifiers

ONC-2012-002

Identifier Type: -

Identifier Source: org_study_id