A Phase 2 interventional study of Triptorelin in Breast Cancer, sponsored by Armando Santoro, MD. Terminated at 1 site in Italy. Open to female participants aged Up to 40 Years. Per ClinicalTrials.gov, last updated 2022-09-10.
Sponsored by Armando Santoro, MD · Phase 2, Interventional, and Prevention
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 45 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Armando Santoro, MD is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Triptorelin 3.75 administered every 28 days, for 4 to 7 injections depending on the number of cycles of chemotherapy
Drug: Triptorelin
Triptorelin administered once every 28 days in addition to chemotherapy
Also known as: Decapeptyl, Gonapeptyl
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
Time frame: 18 months
AMH and menstrual cycle
To correlate AMH behaviour with recovery of menstrual cycle (in the ER negative cohort);
Time frame: 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
Time frame: 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.
Time frame: 18 months
This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Armando Santoro, MD