Pembrolizumab and Exemestane/ Leuprolide in Premenopausal HR+/ HER2- Locally Advanced or Metastatic Breast Cancer

What Was Tested

This registered phase 1, phase 2 trial tested Leuprolide.

This is an open-label, single-arm, multicenter, pilot study of pembrolizumab, exemestane, and leuprolide for subjects being resistant for front-line hormonal therapy for inoperable locally advanced or metastatic hormonal receptor positive (HR+)/ Human epidermal growth factor receptor 2 (HER2) negative breast cancer.

It had 1 arm (groups): Pembrolizumab/ Exemestane/ Leuprolide (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 16 actual participants took part.

It was open to women only aged from 20 years with no upper age limit.

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

Examples of who could join: Be a female adult aged more than 20-year-old at the time of informed consent. Have histologically confirmed HER2-negative breast cancer as defined by IHC ≤ 2+, and/or FISH negative. Have radiological or objective evidence of inoperable locally advanced or metastatic breast cancer. Be premenopausal or peri-menopausal. Premenopausal or peri-menopausal status is defined as below:. Last menstrual period within the last 12 months OR.

The full record lists 20 inclusion and 14 exclusion criteria; among the exclusions: is currently participating in an investigational agent study; is a hepatitis b or c carrier; has concurrent malignancy other than non-melanoma skin cancer.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

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

It started in 2017-09-15 with completion listed for 2022-08-16.

It ran at 1 site in Taiwan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The PFS rate at 8 months (time frame: 28 months).

It also tracked 5 secondary outcomes, for example Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, The PFS based on RECIST 1.1, The overall response rate (ORR) based on RECIST 1.1 and The duration of overall response (DOR) based on RECIST 1.1.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Leuprolide in 16 people.

Its size is small, so on its own it can only give an early look.

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

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