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NCT01776008 · ClinicalTrials.gov registry record · Phase 2
Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT01776008: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01776008 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01776008, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
This phase II trial studies how well Akt inhibitor MK-2206 (MK-2206) and anastrozole with or without goserelin acetate works in treating patients with stage II-III breast cancer. MK-2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole and goserelin acetate may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving MK-2206, anastrozole, and goserelin acetate together may kill more tumor cells.
Primary Outcome
Any woman whose Ki67 value ≤10% on cycle 1 day 17 of combination treatment who does not receive alternative treatment prior to surgery and has no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes is considered to have a pathological complete response (pCR). A ninety percent confidence interval for the true pathologic complete response rate will be calculated using the Duffy-Santer approach.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Anastrozole
- DRUG Goserelin Acetate
- DRUG Akt Inhibitor MK2206
- PROCEDURE Neoadjuvant Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-05-05 |
| Phase | Phase 2 |
Why NCT01776008 stopped before completion
NCT01776008 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01776008 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01776008 about?
NCT01776008 is a clinical study titled "Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer". This phase II trial studies how well Akt inhibitor MK-2206 (MK-2206) and anastrozole with or without goserelin acetate works in treating patients with stage II-III breast cancer. MK-2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the...
What is the current status of trial NCT01776008?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2013-01. Estimated completion is 2015-05-05.
What interventions are being tested in trial NCT01776008?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Anastrozole (DRUG), Goserelin Acetate (DRUG), Akt Inhibitor MK2206 (DRUG), Neoadjuvant Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT01776008?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01776008's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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