Breast Cancer, Premenopausal Breast Cancer
Conditions
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.
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.
Interventions
None listed
Sponsors
Cancer Trials Ireland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | To determine alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens | up to 3 years post chemotherapy | To evaluate the comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens |
| Correlation between CIA and depletion of ovarian follicular reserve. | up to 3 years post chemotherapy | To assess the correlation between CIA and depletion of ovarian follicular reserve. |
| Correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients | 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 |
| 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 | 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). |
Countries
Ireland
Outcome results
None listed