RO4929097 And Exemestane in Treating Pre- and Postmenopausal Patients With Advanced or Metastatic Breast Cancer

What Was Tested

This registered phase 1 trial tested Goserelin.

It had two arms (groups): Arm I (experimental) and Arm II (active comparator).

Patients receive oral exemestane once daily on days 1-21 and oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients receive exemestane as in arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

The registry classes the interventions as drug.

More on the Plan

Determine the safety and tolerability of this regimen in these patients.

Determine the progression-free survival of patients treated with exemestane with vs without RO4929097.

Determine the overall tumor response rate in patients treated with these regimens.

Determine the overall survival of patients treated with these regimens.

Who Took Part

15 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: Relapsed disease with (or within 6 months of discontinuation of) an adjuvant nonsteroidal aromatase inhibitor or tamoxifen. Progressive disease during treatment with first- or second-line hormonal therapy that could include a nonsteroidal aromatase inhibitor, tamoxifen, or fulvestrant. No locally recurrent resectable disease. Histologically confirmed estrogen receptor-positive (ER+) by IHC. No HER2/neu-positive disease.

The full record lists 55 inclusion and 0 exclusion criteria.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2010-10 with completion listed for 2012-12.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Incidence of treatment emergent adverse events (TEAEs) based on CTCAE version 3 grade (time frame: Up to 70 days). Time to relapse (time frame: Up to 2 years).

It also tracked 1 secondary outcome, for example Overall survival.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Goserelin in 15 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 Goserelin compound page, all human trials.