Anti-Mullerian Hormone (AMH) as Marker of Ovarian Reserve

What Was Tested

This registered phase 2 trial tested Triptorelin.

This is a multicentre, prospective study willing to evaluate AMH levels changes in response to chemotherapy plus GnRHa.

In the present study the researchers 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.

It had 1 arm (groups): Triptorelin (experimental).

Triptorelin 3.75 administered every 28 days, for 4 to 7 injections depending on the number of cycles of chemotherapy.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 45 actual participants took part.

It was open to women only aged up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: presence of distant metastasis; psychological or social conditions which might affect study compliance; unstable neurologic function.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Triptorelin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-05 with completion listed for 2016-05.

It ran at 1 site in Italy.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: AMH in response to chemotherapy plus GnRHa (time frame: 18 months).

It also tracked 3 secondary outcomes, for example AMH and menstrual cycle, AMH after chemotherapy and AMH levels >0.2 ng/mL at the 12-month time point.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Triptorelin in 45 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Triptorelin compound page, all human trials.