PErsonalized TREatment of High-risk MAmmary Cancer - the PETREMAC Trial

What Was Tested

In this phase 2 trial, researchers set out to test Goserelin.

Breast cancer is an optimal "model disease" for studying personalized medicine.

Breast cancer was the first malignancy for which a predictive factor forecasting response to therapy was identified nearly 50 years ago; the expression of the estrogen receptor (ER).

It had eight arms (groups): A (experimental), B (experimental), C (experimental), D (experimental) and E (experimental).

The registry classes the interventions as drug, procedure and radiation.

Who Took Part

Enrollment: 200 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: WHO performance status 0-1. Known tumor ER, PGR, HER2 and TP53 status. Distant metastasis not suspected. Patients will undergo radiology exams during screening phase, after signing the informed consent. Age \>18 years. Patients must have clinically and/or radiographically documented measurable breast cancer according to RECIST.

The full record lists 17 inclusion and 8 exclusion criteria; among the exclusions: unstable angina pectoris or heart failure; pregnant or lactating patients can not be included; clinical evidence of serious coagulopathy. prior arterial/venous thrombosis or embolism does not exclude patients from inclusion, unless patient is considered unfit by study oncologist.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Being open-label, the Goserelin 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 2016-04-15 with completion listed for 2020-06-01.

It ran at 7 sites in Norway (7).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Predictive and prognostic value of mutations in 300 cancer-related genes assessed in breast cancer tissue by next generation sequencing before starting neoadjuvant therapy (time frame: Ten years).

It also tracked 7 secondary outcomes, for example To assess genetic/epigenetic changes within the tumor tissue during therapy, The objective response rate (ORR) of personalized medicine, compared to ORR for best standard-of-care using historical data for comparison, To evaluate the percentage of patients completing neoadjuvant treatment and completing surgery, Breast conserving surgery rate (potential to avoid mastectomy) and Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Goserelin in 200 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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