Anti-Mullerian Hormone Study. ICORG 10-16, V2
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ClinicalTrials.gov Identifier: NCT01726322 |
Recruitment Status
:
Recruiting
First Posted
: November 14, 2012
Last Update Posted
: October 6, 2016
|
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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 |
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Premenopausal Breast Cancer Breast Cancer |
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 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 |

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

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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 |
Inclusion Criteria:
- Documented histological diagnosis of invasive breast cancer
- 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]
- Female patients aged between 18 and 42 years
-
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
- Karnofsky score greater or equal to 70
- Ability to provide written informed consent
Exclusion Criteria:
- Patients with hypothalamic/pituitary disorder
- History of ovarian tumour
- Current pregnancy (pregnancy test as per hospital standard prior to treatment)

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
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 |
Responsible Party: | Cancer Trials Ireland |
ClinicalTrials.gov Identifier: | NCT01726322 History of Changes |
Other Study ID Numbers: |
ICORG 10-16 |
First Posted: | November 14, 2012 Key Record Dates |
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 |