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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 is a Phase 2 study that has completed, run by Brown University. The registered enrollment target is 32 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02789657
The ClinicalTrials.gov registry entry for NCT02789657 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Trastuzumab is the first listed.
NCT02789657 reports 0 study locations.
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.
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