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Ovarian Reserve in Premenopausal Breast Cancer

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ClinicalTrials.gov Identifier: NCT01726322
Recruitment Status : Active, not recruiting
First Posted : November 14, 2012
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Premenopausal Breast Cancer 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
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study to Determine Alteration of Hormone Levels in Premenopausal Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Breast Cancer
Actual Study Start Date : September 2012
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer [ Time Frame: 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 :
  1. Comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens [ Time Frame: up to 3 years post chemotherapy ]
    To evaluate the comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens

  2. Correlation between CIA and depletion of ovarian follicular reserve. [ Time Frame: up to 3 years post chemotherapy ]
    To assess the correlation between CIA and depletion of ovarian follicular reserve.

  3. Correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients [ Time Frame: 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

  4. Efficacy of GNRH agonists in preservation of ovarian follicles in premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast cancer [ Time Frame: 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).


Biospecimen Retention:   Samples With DNA
Blood, salivary samples and hair samples.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premenopausal breast cancer patients who are to receive chemotherapy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726322


Locations
Ireland
Beacon Hospital
Dublin, Dublin 18, Ireland
Our Lady of Lourdes Hospital
Drogheda, Louth, Ireland, Co
Bon Secours Hospital
Cork, Ireland
Cork University Hospital
Cork, Ireland
Beaumont Hospital
Dublin, Ireland, 9
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, Ireland
Sponsors and Collaborators
Cancer Trials Ireland

Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT01726322     History of Changes
Other Study ID Numbers: CTRIAL-IE (ICORG) 10-16
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases