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NCT02301988 · ClinicalTrials.gov registry record · Phase 2
A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer
A Phase 2 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 151
- Enrollment target
NCT02301988: Completed Phase 2 study, sponsored by Genentech.
NCT02301988 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 151 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02301988, a Phase 2 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 151 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled, multicenter, pre-operative Phase II study designed to estimate the efficacy of ipatasertib combined with paclitaxel chemotherapy versus placebo combined with paclitaxel chemotherapy in women with Stage Ia - IIIa triple-negative breast adenocarcinoma. The anticipated time on study treatment is 12 weeks.
Primary Outcome
pCR was defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer (AJCC) Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes.
Interventions
- DRUG Placebo
- DRUG Ipatasertib
- DRUG Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2015-02-17 |
| Est. Completion | 2017-08-02 |
| Phase | Phase 2 |
What the finished NCT02301988 record still lists
NCT02301988 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02301988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02301988 about?
NCT02301988 is a clinical study titled "A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer". This is a randomized, double-blind, placebo-controlled, multicenter, pre-operative Phase II study designed to estimate the efficacy of ipatasertib combined with paclitaxel chemotherapy versus placebo combined with paclitaxel chemotherapy in women with Stage Ia - IIIa triple-negative breast adenocarc...
What is the current status of trial NCT02301988?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2015-02-17. Estimated completion is 2017-08-02.
What interventions are being tested in trial NCT02301988?
The interventions under investigation include: Placebo (DRUG), Ipatasertib (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT02301988?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02301988's enrollment target sits among peer trials
151 454th of 2000 higher than 1,546 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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