Anti-Mullerian Hormone Study. ICORG 10-16, V2

Study Description

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Brief Summary:

Primary Objective :

To determine whether pre-treatment levels of anti-mullerian hormone predicts ovarian follicular reserve post adjuvant or neoadjuvant chemotherapy for breast cancer and chemotherapy induced amenorrhea (CIA).

Secondary Objective

• To evaluate the comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens.
• To assess the correlation between CIA and depletion of ovarian follicular reserve.
• To partly externally validate preceding studies of anti-mullerian hormone levels in patients receiving neo-adjuvant/ 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 practices and is not to be influenced by study participation.

Condition or disease
Premenopausal Breast Cancer; Breast Cancer

Detailed Description:

Type of Study: Translational Study

Sample Type: A 10mL blood sample will be collected in red vacutainer tubes (no anticoagulant, no gel) from each patient at the designated time points +/- 7days. Blood should preferably be collected in the follicular phase of the menstrual cycle.

Time of Sample procurement:

• 1st Sample: Pre-Chemotherapy (≤ 14 days pre-treatment)
• 2nd Sample: e.g. before cycle 3, if undergoing a 4 cycle regimen or before cycle 4 in a 6 cycle regimen. (If the chemotherapy regimen changes following the commencement of chemotherapy &/or after surgery, then blood samples will be taken at the time points determined by the original plan i.e. if a patient was to have 6 cycles of chemotherapy and this was then changed to 4 cycles samples will be taken before cycle 4)
• 3rd sample: 3 weeks following the last dose of chemotherapy
• 4th sample: 3 months following the last dose of chemotherapy
• 5th sample: 6 months following the last dose of chemotherapy
• 6th sample: 1 year following the last dose of chemotherapy
• 7th sample: 2 years following the last dose of chemotherapy
• 8th sample: 3 years following the last dose of chemotherapy

Patient's menstrual status including the commencement date of last menstrual period or the use of Intra Uterine Devices (IUD) and FSH, LH and E2 levels will be documented on the Baseline Assessment CRF.

FSH, LH and E2 levels will also be measured at each time point and documented on the Follow-up Assessment CRF.

Study Design

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Study Type :	Observational
Estimated Enrollment :	250 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	A Study to Determine Alteration of Anti-mullerian Hormone (AMH) Concentrations in Premenopausal Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Breast Cancer
Study Start Date :	September 2012
Estimated Primary Completion Date :	September 2018

Groups and Cohorts

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Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change of AMH levels from before starting chemotherapy to predefined intervals concluding at 3 years post completion of chemotherapy [ Time Frame: AMH levels will be taken at specified intervals until 3 years post chemotherapy ]

Secondary Outcome Measures :

1. Frequency of chemotherapy induced amenorrhea in patients treated with and without GNRH agonists. [ Time Frame: up to 3 years post chemotherapy ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 42 Years (Adult)
Sexes Eligible for Study:	Female
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)[Patients treated with GNRH agonist or adjuvant Herceptin or participating in other clinical trials are also eligible]
3. Female patients aged between 18 and 42 years

4. Premenopausal status as defined by a hormone profile (FSH, LH, E2 within the pre-menopausal range as defined by local lab).

   OR

   -The last menstrual period had to be within 180 days

   OR

   -An IUD is used for contraception

5. Karnofsky score greater or equal to 70
6. Ability to provide written informed consent

Exclusion Criteria:

1. Patients with hypothalamic/pituitary disorder
2. History of ovarian tumour
3. Current pregnancy (pregnancy test as per hospital standard prior to treatment)

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Ireland
Beacon Hospital	Recruiting
Bracken Rd, Sandyford Industrial Estate, Dublin 18, Ireland
Contact: Jennifer Westrup 01 293 6600
Contact: Dr Jennifer Westrup
Our Lady of Lourdes Hospital	Recruiting
Drogheda, Louth, Ireland, Co
Contact: Bryan Hennessy, Dr 01-8092010
Principal Investigator: Bryan Hennessy, Dr
Bon Secours Hospital	Recruiting
Cork, Ireland
Contact: Contact Person 021-4542807
Principal Investigator: Brian Bird, Dr
Cork University Hospital	Recruiting
Cork, Ireland
Contact: Contact Person 021-4546400
Principal Investigator: Seamus O'Reilly, Dr
Beaumont Hospital	Recruiting
Dublin, Ireland, 9
Contact: Contact Person 01-8092373
Principal Investigator: Oscar Breathnach, Dr
St James Hospital	Recruiting
Dublin, Ireland
Contact: Contact Person 01-4103000
Principal Investigator: John Kennedy, Dr
St Vincent's University Hospital	Recruiting
Dublin, Ireland
Contact: Contact Person 01-2214000
Principal Investigator: Janice Walshe, Dr
The Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital	Recruiting
Dublin, Ireland
Contact: Contact Person 01- 414 2000
Principal Investigator: Janice Walshe, Dr
Galway University Hospital	Recruiting
Galway, Ireland
Contact: Contact Person 091-544805
Principal Investigator: Maccon Keane, Dr
Sligo General Hospital	Recruiting
Sligo, Ireland
Contact: Contact Person 071- 9171111
Principal Investigator: Michael Martin, Dr
Waterford Regional Hospital	Recruiting
Waterford, Ireland
Contact: Contact Person 051-848000
Principal Investigator: Miriam O'Connor, Dr

Sponsors and Collaborators

Cancer Trials Ireland

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Cancer Trials Ireland
ClinicalTrials.gov Identifier:	NCT01726322 History of Changes
Other Study ID Numbers:	ICORG 10-16
First Posted:	November 14, 2012
Last Update Posted:	October 6, 2016
Last Verified:	October 2016

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases	Skin Diseases; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs