Premenopausal Breast CancerNCT01726322
Ovarian Reserve in Premenopausal Breast Cancer
An observational study of Premenopausal Breast Cancer and Breast Cancer, run by Cancer Trials Ireland at 10 sites in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Premenopausal Breast Cancer, Breast Cancer
- How many people
- 216 participants
- Where
- 10 sitesIreland
- Study dates
- Sep 2012to 13 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Premenopausal breast cancer patients who are to receive chemotherapy
Who may be able to join
- 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
Who cannot join
- Patients with hypothalamic/pituitary disorder
- History of ovarian tumour
- Current pregnancy
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Ireland10 sites
Bon Secours Hospital
Cork
Cork University Hospital
Cork
Our Lady of Lourdes Hospital
Drogheda, Louth, Co
Beacon Hospital
Dublin, Dublin 18
Beaumont Hospital
Dublin, 9
St James Hospital
Dublin
St Vincent's University Hospital
Dublin
Tallaght University Hospital
Dublin
Sligo General Hospital
Sligo
Waterford Regional Hospital
Waterford
About this study
Official title: A Study to Determine Alteration of Hormone Levels in Premenopausal Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Breast Cancer
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.
Read the 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.
- Conditions
- Premenopausal Breast Cancer, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: AMH levels will be taken at specified intervals until 3 years post chemotherapy
Secondary outcomes (4)
Comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens
To evaluate the comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens
Measured: 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.
Measured: 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
Measured: 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).
Measured: up to 3 years post chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startSep 2012
- Primary completion13 Jul 2020
- Study completion13 Jul 2020
Why it stopped: As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenopausal Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726322
- Sponsor's protocol ID
- CTRIAL-IE (ICORG) 10-16
- Status last verified
- Jul 2025
- First submitted
- 9 Nov 2012
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine Alteration of Hormone Levels in Premenopausal Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT01726322
- Acronym / sponsor ID
- CTRIAL-IE (ICORG) 10-16
- Conditions
- Premenopausal Breast Cancer, Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Sep 2012 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 14 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Premenopausal breast cancer patients who are to receive chemotherapy
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with hypothalamic/pituitary disorder
- History of ovarian tumour
- Current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer
Time frame: 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
4 secondary outcomes
Comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens
Time frame: up to 3 years post chemotherapy
Correlation between CIA and depletion of ovarian follicular reserve.
Time frame: up to 3 years post chemotherapy
Correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients
Time frame: 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
Time frame: up to 3 years post chemotherapy
Results and safety
The study was stopped early (reason given: As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
Related trials for Premenopausal Breast Cancer
RecruitingPhase 2
A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer
Breast Neoplasms
RecruitingPhase 3
Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25
Breast Cancer
Active, not recruitingPhase 3
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
Early Breast Cancer
Enrolling by invitationPhase 3
Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
Breast Cancer
Active, not recruitingPhase 3
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premenopausal Breast Cancer and Breast Cancer, run by Cancer Trials Ireland at 10 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer (time frame: AMH levels will be taken at specified intervals until 3 years post chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.