Clinical trial NCT01726322: Ovarian Reserve in Premenopausal Breast Cancer
Official title: A Study to Determine Alteration of Hormone Levels in Premenopausal Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Premenopausal Breast Cancer
Breast Cancer
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2012-11-14
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premenopausal breast cancer patients who are to receive chemotherapy

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.

Eligibility 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

Primary outcomes:
measure: Alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer
timeFrame: AMH levels will be taken at specified intervals until 3 years post chemotherapy
Secondary outcomes:
measure: Comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens
timeFrame: up to 3 years post chemotherapy
measure: Correlation between CIA and depletion of ovarian follicular reserve.
timeFrame: up to 3 years post chemotherapy
measure: Correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients
timeFrame: up to 3 years post chemotherapy
measure: Efficacy of GNRH agonists in preservation of ovarian follicles in premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast cancer
timeFrame: up to 3 years post chemotherapy
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beacon Hospital
state: Dublin 18
city: Drogheda
country: Ireland
facility: Our Lady of Lourdes Hospital
state: Louth
city: Cork
country: Ireland
facility: Bon Secours Hospital
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: St James Hospital
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Dublin
country: Ireland
facility: Tallaght University Hospital
city: Sligo
country: Ireland
facility: Sligo General Hospital
city: Waterford
country: Ireland
facility: Waterford Regional Hospital
Study officials:
References: