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NCT01790932 · ClinicalTrials.gov registry record · Phase 2
BKM120 For Triple Negative Breast Cancer
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01790932: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT01790932 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01790932, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
Triple negative breast cancer (TNBC) has an aggressive phenotype and poor prognosis. This tumor type characterized by lack of expression of estrogen receptor (ER), progesterone receptor (PR) and no amplification of the human epidermal growth factor 2 (HER2) accounts for 15% of breast cancers. Limited treatment options exist in the clinic as hormonal therapies and HER2-trageted agents have proven ineffective. BKM120 is a drug that works by blocking a protein called phosphatidylinositol-3-kinase (PI3K) which may contribute to cancer growth. This drug has been used in experiments in the laboratory and information from these research studies suggests that BKM120 may help to prevent cancer cells from growing. In this research study, the investigators are looking to see if BKM120 works to stop breast cancer cells from growing.
Primary Outcome
Clinical benefit rate (CBR) was defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) for 4 months or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest
Interventions
- DRUG BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
What the finished NCT01790932 record still lists
NCT01790932 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which BKM120 is the first listed.
NCT01790932 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01790932 about?
NCT01790932 is a clinical study titled "BKM120 For Triple Negative Breast Cancer". Triple negative breast cancer (TNBC) has an aggressive phenotype and poor prognosis. This tumor type characterized by lack of expression of estrogen receptor (ER), progesterone receptor (PR) and no amplification of the human epidermal growth factor 2 (HER2) accounts for 15% of breast cancers. Limite...
What is the current status of trial NCT01790932?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2012-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01790932?
The interventions under investigation include: BKM120 (DRUG).
Who is sponsoring clinical trial NCT01790932?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01790932's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 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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