Breast CancerPhase 2NCT02113553
Anti-Mullerian Hormone (AMH) as Marker of Ovarian Reserve
A Phase 2 study testing Triptorelin in people with Breast Cancer, run by Armando Santoro, MD at 1 site in Italy.
Trial summary
This is a multicentre, prospective study willing to evaluate AMH levels changes in response to chemotherapy plus GnRHa. In the present study we propose to determine AMH levels in breast cancer patients, aged <40yrs receiving adjuvant chemotherapy and ovarian suppression by means of GnRHa with the aim to assess the… Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Triptorelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Dec 2016
- Phase
- Phase 2
- 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 Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female subjects, aged <40yr at the time of breast cancer diagnosis
- Diagnosis of operable breast cancer any T and N, any ER
- Patients candidate to adjuvant chemotherapy for 4-8 cycles.
- Patients compliant to adhere to all protocol procedures.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 28 days prior to the start of the study treatment.
- Negative pregnancy test at the study enrolment; fertile women must use effective contraception during chemotherapy
- Patients must be able to understand and sign written informed consent.
- -
Who cannot join
- Presence of distant metastasis
- Clinically significant cardiovascular disease
- Psychological or social conditions which might affect study compliance
- Unstable neurologic function
- Patients with known allergy to any of the components of the study medication
- Pregnancy or lactation
- Any condition that, in the opinion of the physician is likely to affect inclusion of the subject into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ANTI-MULLERIAN HORMONE (AMH) AS A MARKER OF OVARIAN RESERVE IN YOUNG BREAST CANCER PATIENTS RECEIVING CHEMOTHERAPY + GnRH ANALOGUE
This is a multicentre, prospective study willing to evaluate AMH levels changes in response to chemotherapy plus GnRHa.
In the present study we propose to determine AMH levels in breast cancer patients, aged <40yrs receiving adjuvant chemotherapy and ovarian suppression by means of GnRHa with the aim to assess the role of AMH as surrogate marker of the preservation of ovarian reserve exerted by GnRHa.
Read the detailed description
Patients will receive 4 to 8 cycles of chemotherapy according to Institutional guidelines. Triptorelin 3.75 will be administered as an intramuscular injection before chemotherapy and every 28 days thereafter for all the duration of chemotherapy in patients with ER negative tumors and for 2 to 5 years in patients with ER positive tumors according to Institutional guidelines. Patients with ER+ve tumour will receive tamoxifen for 5 years at the end of chemotherapy as standard care. A blood sample will be drawn after signed informed consent to determine baseline AMH levels. A blood sample for determination of AMH levels will be collected at the end of chemotherapy and at 12 months after the end of chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Triptorelin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriptorelinDrug
Also called Decapeptyl, Gonapeptyl
Triptorelin administered once every 28 days in addition to chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Triptorelin | Experimental | Triptorelin 3.75 administered every 28 days, for 4 to 7 injections depending on the number of cycles of chemotherapy Receives: Drug: Triptorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMH in response to chemotherapy plus GnRHa
To evaluate AMH levels changes in response to chemotherapy plus GnRHa in order to assess the role of AMH as surrogate marker of the preservation of ovarian reserve exerted by GnRHa
Measured: 18 months
Secondary outcomes (3)
AMH and menstrual cycle
To correlate AMH behaviour with recovery of menstrual cycle (in the ER negative cohort);
Measured: 18 months
AMH after chemotherapy
To compare AMH levels obtained at the end of chemotherapy and at 12 months after the end of chemotherapy in the two cohorts of ER positive and ER negative patients
Measured: 18 months
AMH levels >0.2 ng/mL at the 12-month time point
Evaluate the proportion of patients with AMH levels >0.2 ng/mL at the 12-month time point.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2016
- Study completionDec 2016
Why it stopped: target population not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armando Santoro, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Armando Santoro, MD, Istituto Clinico Humanitas
- Investigators
- Armando Santoro, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113553
- Sponsor's protocol ID
- ONC-2012-002
- Status last verified
- Sep 2022
- First submitted
- 27 May 2013
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANTI-MULLERIAN HORMONE (AMH) AS A MARKER OF OVARIAN RESERVE IN YOUNG BREAST CANCER PATIENTS RECEIVING CHEMOTHERAPY + GnRH ANALOGUE
- ClinicalTrials.gov ID
- NCT02113553
- Acronym / sponsor ID
- ONC-2012-002
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: target population not reached
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Armando Santoro, MDUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Apr 2014 (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 multicentre, prospective study willing to evaluate AMH levels changes in response to chemotherapy plus GnRHa.
In the present study we propose to determine AMH levels in breast cancer patients, aged <40yrs receiving adjuvant chemotherapy and ovarian suppression by means of GnRHa with the aim to assess the role of AMH as surrogate marker of the preservation of ovarian reserve exerted by GnRHa.
Detailed description
Patients will receive 4 to 8 cycles of chemotherapy according to Institutional guidelines. Triptorelin 3.75 will be administered as an intramuscular injection before chemotherapy and every 28 days thereafter for all the duration of chemotherapy in patients with ER negative tumors and for 2 to 5 years in patients with ER positive tumors according to Institutional guidelines. Patients with ER+ve tumour will receive tamoxifen for 5 years at the end of chemotherapy as standard care. A blood sample will be drawn after signed informed consent to determine baseline AMH levels. A blood sample for determination of AMH levels will be collected at the end of chemotherapy and at 12 months after the end of chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triptorelin | Experimental | Drug: TriptorelinTriptorelin 3.75 administered every 28 days, for 4 to 7 injections depending on the number of cycles of chemotherapy |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Female subjects, aged <40yr at the time of breast cancer diagnosis
- Diagnosis of operable breast cancer any T and N, any ER
- Patients candidate to adjuvant chemotherapy for 4-8 cycles.
- Patients compliant to adhere to all protocol procedures.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 28 days prior to the start of the study treatment.
Key exclusion criteria (7 listed)
- Presence of distant metastasis
- Clinically significant cardiovascular disease
- Psychological or social conditions which might affect study compliance
- Unstable neurologic function
- Patients with known allergy to any of the components of the study medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriptorelinAlso: Decapeptyl, GonapeptylTriptorelin administered once every 28 days in addition to chemotherapy | Drug | Triptorelin |
Primary outcome
AMH in response to chemotherapy plus GnRHa
Time frame: 18 months
To evaluate AMH levels changes in response to chemotherapy plus GnRHa in order to assess the role of AMH as surrogate marker of the preservation of ovarian reserve exerted by GnRHa
3 secondary outcomes
AMH and menstrual cycle
Time frame: 18 months
AMH after chemotherapy
Time frame: 18 months
AMH levels >0.2 ng/mL at the 12-month time point
Time frame: 18 months
Results and safety
The study was stopped early (reason given: target population not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
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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.
Armando Santoro, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Triptorelin in people with Breast Cancer, run by Armando Santoro, MD at 1 site in Italy.
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 7 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 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: target population not reached). 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?
AMH in response to chemotherapy plus GnRHa (time frame: 18 months). 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 10 Sep 2022.