Ovarian Reserve in Premenopausal Breast Cancer

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Premenopausal Breast Cancer

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 Type: Observational
• Enrollment (Actual): 216

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • Bon Secours Hospital
  • Cork, Ireland
    • Cork University Hospital
  • Dublin, Ireland, 9
    • Beaumont Hospital
  • Dublin, Ireland
    • St Vincent's University Hospital
  • Dublin, Ireland
    • Tallaght University Hospital
  • Dublin, Ireland
    • St James Hospital
  • Sligo, Ireland
    • Sligo General Hospital
  • Waterford, Ireland
    • Waterford Regional Hospital
  • Dublin 18
    • Dublin, Dublin 18, Ireland
      • Beacon Hospital
  • Louth
    • Drogheda, Louth, Ireland, Co
      • Our Lady of Lourdes Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Premenopausal breast cancer patients who are to receive chemotherapy

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Cancer Trials Ireland

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Actual): July 13, 2020
• Study Completion (Actual): July 13, 2020

Study Registration Dates

• First Submitted: November 9, 2012
• First Submitted That Met QC Criteria: November 9, 2012
• First Posted (Estimate): November 14, 2012

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CTRIAL-IE (ICORG) 10-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No