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

NCT02113553 | Terminated Phase 2 DMC

• 1 other identifier: ONC-2012-002
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• AMH and menstrual cycle

  18 months

• AMH after chemotherapy

  18 months

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

  18 months

Study Arms (1)

Triptorelin

EXPERIMENTAL

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

Drug: Triptorelin

Interventions

Triptorelin DRUG

Triptorelin administered once every 28 days in addition to chemotherapy

Also known as: Decapeptyl, Gonapeptyl

Triptorelin

Eligibility Criteria

• Age: Up to 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female subjects, aged \<40yr at the time of breast cancer diagnosis
• Diagnosis of operable breast cancer any T and N, any ER
• Patients candidate to adjuvant chemotherapy for 4-8 cycles.
• Patients compliant to adhere to all protocol procedures.
• 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.
• Negative pregnancy test at the study enrolment; fertile women must use effective contraception during chemotherapy
• Patients must be able to understand and sign written informed consent.

You may not qualify if:

• Presence of distant metastasis
• Clinically significant cardiovascular disease
• Psychological or social conditions which might affect study compliance
• Unstable neurologic function
• Patients with known allergy to any of the components of the study medication
• Pregnancy or lactation

Sponsors & Collaborators

• Armando Santoro, MD: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Armando Santoro, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: April 14, 2014
• Study Start: May 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 10, 2022

Record last verified: 2022-09

Locations

IT (1)