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

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: 14.1Level: LLTClassification code 10006203Term: Breast cancer stage unspecifiedSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-005337-37-IT

Lead Sponsor: Istituto Clinico Humanitas

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

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)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.
5)Negative pregnancy test at the study enrolment; fertile women must use effective contraception during chemotherapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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