Ovarian Reserve in Premenopausal Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Study to Determine Alteration of Hormone Levels in Premenopausal Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01726322
• Other study ID #: CTRIAL-IE (ICORG) 10-16
• Status: Terminated
• Start date: September 2012
• Est. completion date: July 13, 2020

Study information

• Verified date: April 2023
• Source: Cancer Trials Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 216
• Est. completion date: July 13, 2020
• Est. primary completion date: July 13, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Premenopausal Breast Cancer

Locations

Country	Name	City	State
Ireland	Bon Secours Hospital	Cork
Ireland	Cork University Hospital	Cork
Ireland	Our Lady of Lourdes Hospital	Drogheda	Louth
Ireland	Beacon Hospital	Dublin	Dublin 18
Ireland	Beaumont Hospital	Dublin
Ireland	St James Hospital	Dublin
Ireland	St Vincent's University Hospital	Dublin
Ireland	Tallaght University Hospital	Dublin
Ireland	Sligo General Hospital	Sligo
Ireland	Waterford Regional Hospital	Waterford

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Trials Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer	To determine 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
Secondary	Comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens	To evaluate the comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens	up to 3 years post chemotherapy
Secondary	Correlation between CIA and depletion of ovarian follicular reserve.	To assess the correlation between CIA and depletion of ovarian follicular reserve.	up to 3 years post chemotherapy
Secondary	Correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients	To determine the correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients	up to 3 years post chemotherapy
Secondary	Efficacy of GNRH agonists in preservation of ovarian follicles in premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast cancer	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).	up to 3 years post chemotherapy