Ovarian Reserve in Premenopausal Breast Cancer

NCT01726322 | Terminated

• 1 other identifier: CTRIAL-IE (ICORG) 10-16
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 10

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.

Conditions

Premenopausal Breast Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

  up to 3 years post chemotherapy

• 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

  up to 3 years post chemotherapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Premenopausal breast cancer patients who are to receive chemotherapy

You may qualify if:

• Documented histological diagnosis of invasive breast cancer
• Patient due to be treated with chemotherapy (neoadjuvant or adjuvant)\*
• Female patients aged between 18 and 50 years
• 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.
• Ability to provide written informed consent
• Patients treated with GNRH agonist or adjuvant Herceptin or participating in other clinical trials are also eligible

You may not qualify if:

• Patients with hypothalamic/pituitary disorder
• History of ovarian tumour
• Current pregnancy

Sponsors & Collaborators

• Cancer Trials Ireland: lead

Study Sites (10)

Beacon Hospital

Dublin, Dublin 18, Ireland

Location

Our Lady of Lourdes Hospital

Drogheda, Louth, Co, Ireland

Location

Bon Secours Hospital

Cork, Ireland

Location

Cork University Hospital

Cork, Ireland

Location

Beaumont Hospital

Dublin, 9, Ireland

Location

St James Hospital

Dublin, Ireland

Location

St Vincent's University Hospital

Dublin, Ireland

Location

Tallaght University Hospital

Dublin, Ireland

Location

Sligo General Hospital

Sligo, Ireland

Location

Waterford Regional Hospital

Waterford, Ireland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, salivary samples and hair samples.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: November 14, 2012
• Study Start: September 1, 2012
• Primary Completion: July 13, 2020
• Study Completion: July 13, 2020
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

IE (10)