Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer

What Was Tested

This registered phase 3 trial tested Goserelin.

It had three arms (groups): ribociclib + letrozole cohort A (experimental), ribociclib + letrozole cohort B1 (experimental) and ribociclib + letrozole cohort B2 (experimental).

The registry classes the interventions as drug.

More on the Plan

Furthermore, this trial aimed to collect data for the combination of ribociclib and letrozole in the context of current local routine therapy algorithms for the treatment of metastatic and advanced breast cancer.

For ethical reasons no endocrine comparator drugs were investigated in this study.

The duration of study treatment of 80 weeks was adequate to determine the primary, secondary and exploratory study parameters.

Thus, for ethical reasons no endocrine comparator drugs were investigated in the present RIBECCA study.

Who Took Part

Enrollment: 502 actual participants took part.

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: Patient is an adult, ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines. Women and men with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive and HER2-negative breast cancer by local laboratory. Local pathology is sufficient for assessment. Patient must have either:. Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria ).

The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: patient who received any cdk4/6 inhibitor or any mtor inhibitor; patient has a known hypersensitivity to any of the excipients of ribociclib or letrozole; patients with current inflammatory breast cancer.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Goserelin 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 2016-10-24 with completion listed for 2018-12-11.

It ran at 84 sites in Germany (84).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 10 secondary outcomes, for example Change From Baseline at Week 24 of Patient Reported Quality of Life (QoL) Via EORTC QLQ-C30, Patient Reported Quality of Life (QoL) Via EORTC BR-23 - Change From Baseline at Week 24 (Cycle 7) and Number of Participants With Treatment Emergent Adverse Events (TEAE).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Goserelin in 502 people.

With 502 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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