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NCT01796197 · ClinicalTrials.gov registry record · Phase 2
Paclitaxel + Trastuzumab + Pertuzumab as Pre-Op for Inflammatory BrCa
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT01796197: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT01796197 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01796197, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. In this study, paclitaxel and trastuzumab are being combined with pertuzumab which is "investigational" for the preoperative treatment of inflammatory breast cancer. Trastuzumab is given for a total of 12 months for the treatment of HER2 positive breast cancer. This study also adds pertuzumab to trastuzumab so that both drugs are given for a total of 12 months; this combination is also "investigational". "Investigational" means that pertuzumab is being studied. It also means that although the FDA has approved pertuzumab for preoperative use to treat breast cancer, it has not been thoroughly studied in combination with paclitaxel and trastuzumab for preoperative treatment of inflammatory breast cancer. It has been FDA approved for specific use in advanced breast cancer that is HER2 positive. Pertuzumab is an antibody, which is a protein that attacks a foreign substance is the body. Pertuzumab blocks the function of the HER2 protein like trastuzumab does. However, pertuzumab binds to a different part of the HER2 receptor and stops cancer cells from growing. This drug has been used in the treatment of advanced breast cancer that is HER2 positive, and has been combined with trastuzumab and chemotherapy in those studies. Information from those other research studies suggests that pertuzumab may help to kill the cancer cells in the breast and enable you to undergo a mastectomy. The addition of pertuzumab may also help reduce the chance of cancer recurrence. In this research study, we are combining pertuzumab with paclitaxel and trastuzumab as preoperative therapy and will determine the response of the cancer remaining in the breast at the time of mastectomy. In addition, we are combining trastuzumab with pertuzumab for a total of 12 months and we are looking to see whether the combination re
Primary Outcome
Pathologic complete response (pCR) is defined as absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative treatment. Participants whose disease is not surgically resectable following preoperative treatment are considered as not having pCR.
Interventions
- DRUG Trastuzumab
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Paclitaxel
- DRUG Pertuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2013-08 |
| Est. Completion | 2026-01 |
| Phase | Phase 2 |
What the finished NCT01796197 record still lists
NCT01796197 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 5 interventions - of which Trastuzumab is the first listed.
NCT01796197 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01796197 about?
NCT01796197 is a clinical study titled "Paclitaxel + Trastuzumab + Pertuzumab as Pre-Op for Inflammatory BrCa". This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. In this study, paclitaxel and trastuzumab are being combined with pertuzumab which is "investigational" for the preoper...
What is the current status of trial NCT01796197?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2013-08. Estimated completion is 2026-01.
What interventions are being tested in trial NCT01796197?
The interventions under investigation include: Trastuzumab (DRUG), Cyclophosphamide (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), Pertuzumab (DRUG).
Who is sponsoring clinical trial NCT01796197?
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 NCT01796197's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 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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