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Trial of MK-2206 + Endocrine Treatment in Patients With Hormone Receptor Positive Breast Cancer
Plain-language guide to NCT01240941: phase 2 interventional trial of Goserelin. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01240941
- Phase
- phase 2
- Status
- withdrawn
- Start
- 2011-02
- Completion (planned or actual)
- 2012-06
- Participants
- n/a (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Metastatic Breast Cancer
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Goserelin.
It had 1 arm (groups): MK-2206 (experimental).
The registry classes the interventions as drug.
Who 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 female and greater than or equal to 18 years of age on the day of signing informed. Patient must have performance status of 0 or 1 on the ECOG Performance Scale. Patient must have adequate organ function as indicated by the following laboratory values:. Post-menopausal female subjects should be defined prior to protocol enrollment by any of the following:. Subjects at least 55 years of age.
The full record lists 13 inclusion and 22 exclusion criteria; among the exclusions: patients must be at least 4 weeks post major surgical procedure, and all surgical wounds must be fully healed; patient is currently participating or has participated in a study with an investigational compound or device within 30 days of study day 1; patient has a primary central nervous system tumor.
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 2011-02 with completion listed for 2012-06.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 2 secondary outcomes, for example Characterize the effect of MK-2206 in combination with exemestane +/- goserelin based on PI3K, AKT, and PTEN mutations.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Goserelin in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Goserelin compound page, all human trials.
Our Notes on the Compound
Goserelin: A GnRH analog implant (Zoladex) used to lower sex-hormone levels in prostate and breast cancer and gynecologic conditions.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.