PalbocIclib in PreMenopausal Women With ER Positive/HER-2 Negative MetAstatic Breast Cancer

What Was Tested

This registered phase 2 trial tested Goserelin.

This is an open label, randomized, multicenter, international phase II study for premenopausal patients with hormone receptor positive, HER2 negative metastatic or locally advanced breast cancer.

Patients will be randomized to receive either palbociclib + exemestane + OFS (Arm 1) or exemestane +OFS (Arm 2).

Treatment will be continued until disease progression, unacceptable toxicities, or withdrawal of consent.

It had two arms (groups): Palbociclib Arm (experimental) and Control Arm (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 160 planned participants were the target.

It was open to women only 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: HER2 negative breast cancer as confirmed by IHC, SISH or FISH. Measurable disease according to RECIST or bone-only metastases. Previously irradiated lesions are deemed measurable only if progression is documented at the site after completion of radiation. ECOG Performance Status 0, 1, \& 2. Adequate organ function as defined by the following criteria:. Written informed consent obtained before any trial related activity and according to local guidelines.

The full record lists 10 inclusion and 18 exclusion criteria; among the exclusions: patients with primary endocrinal resistance, defined as recurrence within 24 months from the start of adjuvant tamoxifen treatment; symptomatic and/or life threatening visceral metastases i. diffuse lymphangitic carcinomatosis. ii. bulky liver or pulmonary metastases; patients with only non-measurable lesions other than bone metastasis as defined above (e.g., pleural effusion, ascites, etc.).

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Goserelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Goserelin group and the comparison group ran side by side rather than switching.

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

It started in 2019-05-07 with completion listed for 2021-12.

It ran at 1 site in South Africa.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Progression free survival (time frame: 28 months).

It also tracked 4 secondary outcomes, for example Overall response rate, Overall survival and Incidence of treatment related adverse events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Goserelin in 160 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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