Ovarian Reserve in Premenopausal Breast Cancer

Cancer Trials Ireland

Status: Terminated

Conditions: Breast Cancer; Premenopausal Breast Cancer

Study type: Observational

Funder types: NETWORK

Identifiers

NCT01726322

CTRIAL-IE (ICORG) 10-16

Details and patient eligibility

About

This is a translational, mutlicentre study. The aim of this study is to determine whether pre-treatment levels of hormones predict ovarian follicular reserve post adjuvant or neoadjuvant chemotherapy for breast cancer and chemotherapy induced amenorrhea.

Full description

It is proposed that levels of AMH and inhibin A and B measured will give an indication of the residual ovarian reserve in women with breast cancer treated with chemotherapy. In addition, AMH might give an indication of the possible efficacy of GNRH agonists in fertility preservation and the effect on ovarian follicular reserve using different adjuvant chemotherapy regimens. Those likely to be offered GNRH agonists are younger women with no children and a wish to have some in the future. Older women who have completed their families are less likely to be offered a GNRH agonist.

Enrollment: 216 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Documented histological diagnosis of invasive breast cancer

2. Patient due to be treated with chemotherapy (neoadjuvant or adjuvant)*

3. Female patients aged between 18 and 50 years

4. Premenopausal status as defined by a hormone profile within the pre-menopausal range as defined by local lab

   OR The patient's last menstrual period had to be within the last 180 days

   OR An IUD is used for contraception.

5. Ability to provide written informed consent

   • Patients treated with GNRH agonist or adjuvant Herceptin or participating in other clinical trials are also eligible

Exclusion criteria

1. Patients with hypothalamic/pituitary disorder
2. History of ovarian tumour
3. Current pregnancy