Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer

What Was Tested

The trial (phase 2) is built around Goserelin.

MK-2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

It had 1 arm (groups): Treatment (MK2206, anastrozole, goserelin acetate) (experimental).

Patients receive Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; anastrozole PO daily on days 1-28; and goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

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

More on the Plan

To estimate the rate of clinical response and radiologic response using the World Health Organization (WHO) criteria.

For pre and post-menopausal women separately, to examine serum estradiol levels prior to pre-registration, prior to registration, after 2 cycles of anastrozole plus MK-2206 (cycle 3 day 1) and pre surgery.

To examine the percent change in the apoptotic index after 2 weeks of combination therapy with MK-2206 and anastrozole (cycle 1 day 17) relative to apoptotic index after 4 weeks of treatment with anastrozole alone (pre MK-2206).

To examine the change in Ki67 levels after 2 weeks of combination therapy with MK-2206 and anastrozole (cycle 1 day 17) relative to that after 4 weeks of treatment with anastrozole alone (pre MK-2206).

Who Took Part

16 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: Note: if the patient has invasive or ductal carcinoma in situ (DCIS) in the contralateral breast the patient is not eligible for this study. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Life expectancy \> 4 months. Leukocytes \>= 3,000/mcL. Absolute neutrophil count \>= 1,500/mcL.

The full record lists 25 inclusion and 32 exclusion criteria; among the exclusions: radiation therapy; hormonal therapy; investigational agent prior to study entry.

How the Study Was Run

The set-up was 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 2013-01 with completion listed for 2015-05.

It ran at 8 sites in United States (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Pathological Complete Response Rate (time frame: At time of surgery (up to 3 weeks after 4, 28-day cycles)).

It also tracked 3 secondary outcomes, for example Clinical Response Rate and Radiological Response Rate.

What This Means in Plain Language

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

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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