Ovarian Reserve in Premenopausal Breast Cancer

Terminated

• Conditions: Breast Cancer; Premenopausal Breast Cancer

• Registration Number: NCT01726322
• Lead Sponsor: Cancer Trials Ireland

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-11-09
• Study First Submitted QC: 2012-11-09
• Study First Posted: 2012-11-14
• Primary Completion: 2020-07-13
• Study Completion: 2020-07-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 216

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer	AMH levels will be taken at specified intervals until 3 years post chemotherapy	To determine alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer

Secondary Outcome Measures

Name	Time	Method
Comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens	up to 3 years post chemotherapy	To evaluate the comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens
Correlation between CIA and depletion of ovarian follicular reserve.	up to 3 years post chemotherapy	To assess the correlation between CIA and depletion of ovarian follicular reserve.
Correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients	up to 3 years post chemotherapy	To determine the correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients
Efficacy of GNRH agonists in preservation of ovarian follicles in premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast cancer	up to 3 years post chemotherapy	To determine the efficacy of GNRH agonists in preservation of ovarian follicles in premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast cancer (administration of GNRH agonists is dependent on the treating oncologist's judgment of the patient's case and prac-tices and is not to be influenced by study participation).

Trial Locations

Locations (10)

Beaumont Hospital; 🇮🇪 Dublin, Ireland

St Vincent's University Hospital; 🇮🇪 Dublin, Ireland

St James Hospital; 🇮🇪 Dublin, Ireland

Waterford Regional Hospital; 🇮🇪 Waterford, Ireland

Beacon Hospital; 🇮🇪 Dublin, Dublin 18, Ireland

Our Lady of Lourdes Hospital; 🇮🇪 Drogheda, Louth, Ireland

Bon Secours Hospital; 🇮🇪 Cork, Ireland

Cork University Hospital; 🇮🇪 Cork, Ireland

Tallaght University Hospital; 🇮🇪 Dublin, Ireland

Sligo General Hospital; 🇮🇪 Sligo, Ireland