Ovarian Reserve in Premenopausal Breast Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Premenopausal Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients with hypothalamic/pituitary disorder History of ovarian tumour Current pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 |