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NCT02789657 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Therapy in Clinical Stage I-III HER2-positive Breast Cancer.
A Phase 2 study, sponsored by Brown University.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT02789657: Completed Phase 2 study, sponsored by Brown University.
NCT02789657 is a Phase 2 study that has completed, run by Brown University. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02789657, a Phase 2 study, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
Neoadjuvant therapy is given to breast cancer patients whose cancers are relatively large or have spread to lymph nodes or both. The primary goal of this treatment is to prevent the cancer from coming back (recurring) elsewhere in the body, but if it makes the cancer in the breast and lymph nodes shrink it might be easier to remove. This could allow a patient to have a lumpectomy instead of a mastectomy and reduce the number of lymph nodes that the surgeon has to remove. In some cases, the neoadjuvant therapy works so well that it kills all of the cancer in the breast and lymph nodes. This is referred to as a pathologic complete response (pCR). Patients who achieve a pCR have a much lower risk of the cancer recurring elsewhere in their bodies. Investigators aren't sure which chemotherapy drugs work best with the HER2-targeted drugs, and what combination of these drugs causes the fewest side effects.Thus, this study has two main goals: 1. To find out if treatment with wPCbTP, weekly paclitaxel and carboplatin given with trastuzumab and pertuzumab every 3 weeks, leads to as many pCRs as TCHP in patients with HER2-positive breast cancer, but has fewer side effects. 2. To find out if HER2-positive patients whose cancers are not responding well after 12 weeks of wPCbTP get a better response when they are switched to a doxorubicin-containing regimen called AC for 4 cycles (8-12 weeks).
Primary Outcome
pCR is pathologic complete response defined as ypT0/isN0 on pathology report
Interventions
- DRUG Trastuzumab
- DRUG Pertuzumab
- DRUG carboplatin
- DRUG paclitaxel
- PROCEDURE Breast surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2016-11-21 |
| Est. Completion | 2020-03-27 |
| Phase | Phase 2 |
What the finished NCT02789657 record still lists
NCT02789657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 5 interventions - of which Trastuzumab is the first listed.
NCT02789657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02789657 about?
NCT02789657 is a clinical study titled "Neoadjuvant Therapy in Clinical Stage I-III HER2-positive Breast Cancer.". Neoadjuvant therapy is given to breast cancer patients whose cancers are relatively large or have spread to lymph nodes or both. The primary goal of this treatment is to prevent the cancer from coming back (recurring) elsewhere in the body, but if it makes the cancer in the breast and lymph nodes sh...
What is the current status of trial NCT02789657?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2016-11-21. Estimated completion is 2020-03-27.
What interventions are being tested in trial NCT02789657?
The interventions under investigation include: Trastuzumab (DRUG), Pertuzumab (DRUG), carboplatin (DRUG), paclitaxel (DRUG), Breast surgery (PROCEDURE).
Who is sponsoring clinical trial NCT02789657?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02789657's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 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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