ANTI-MULLERIAN HORMONE (AMH) AS A MARKER OF OVARIAN RESERVE IN YOUNG BREAST CANCER PATIENTS RECEIVING CHEMOTHERAPY

ANTI-MULLERIAN HORMONE (AMH) AS A MARKER OF OVARIAN RESERVE IN YOUNG BREAST CANCER PATIENTS RECEIVING CHEMOTHERAPY + GnRH ANALOGUE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005337-37-IT

Enrollment

Registered

2013-03-14

Start date

2013-05-07

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female subjects, 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. MedDRA version: 14.1 Level: LLT Classification code 10006203 Term: Breast cancer stage unspecified System Organ Class: 100000004864

Interventions

Trade Name: Decapeptyl Product Name: Decapeptyl Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: TRIPTORELIN CAS Number: 57773-63-4 Concentration unit: mg millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Female subjects, aged =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 e) Patients with known allergy to any of the components of the study medication 5) Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 Objective: a)to correlate AMH behaviour with recovery of menstrual cycle (in the ER negative cohort); b)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 c)the proportion of patients with AMH levels >0.2 ng/mL at the 12-month time point. ;Primary end point(s): The principal endpoint is the proportion of breast cancer women < 40 yrs with a percent change or ? = 50% of AMH levels at 12 months after chemotherapy as compared with basal levels. ;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: 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 Objective: a)to correlate AMH behaviour with recovery of menstrual cycle (in the ER negative cohort); b)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 c)the proportion of patients with AMH levels >0.2 ng/mL at the 12-month time point. ;Primary end point(s): The principal endpoint is the proportion of breast cancer women < 40 yrs with a percent change or ? = 50% of AMH levels at 12 months after chemotherapy as compared with basal levels. ;Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): a) to correlate AMH behaviour with recovery of menstrual cycle (in the ER negative cohort); b) 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 c) the proportion of patients with AMH levels >0.2 ng/mL at the 12-month time point; d) In centres with reproductive gynaecologic facilities, the antral follicle count (AFC) ,which is considered as a reliable marker of ovarian reserve will be determined at baseline and at the 12-month time point in the ER negative cohort ;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Secondary end point(s): a) to correlate AMH behaviour with recovery of menstrual cycle (in the ER negative cohort); b) 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 c) the proportion of patients with AMH levels >0.2 ng/mL at the 12-month time point; d) In centres with reproductive gynaecologic facilities, the antral follicle count (AFC) ,which is considered as a reliable marker of ovarian reserve will be determined at baseline and at the 12-month time point in the ER negative cohort ;Timepoint(s) of evaluation of this end point: 12 months

—

Countries

Italy

Contacts

Public ContactDirezione Ricerca Clinica

EMMEDI Srl divisione Solaris

regulatory@solaris-italy.com00390276115147

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026