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NCT01855828 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer
A Phase 2 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01855828: Completed Phase 2 study, sponsored by Yale University.
NCT01855828 is a Phase 2 study that has completed, run by Yale University. 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
NCT01855828, a Phase 2 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
The main goal of this clinical trial is to test if adding pertuzumab (Perjeta), improves the anticancer activity of the combination chemotherapy regimen of trastuzumab (Herceptin) concomitant with paclitaxel, 5-fluorouracil, epirubicin, and cyclophosphamide (T-FEC). The study will also test the safety of this therapy.
Primary Outcome
To estimate the pathologic complete response rate (pCR) when pertuzumab is added to weekly trastuzumab/paclitaxel followed by trastuzumab/5-fluorouracil, epirubicin and cyclophosphamide neoadjuvant chemotherapy in HER2-positive breast cancer. This study will assess pCR rates separately in ER+ and ER- cancers. Pathologic complete response is defined as no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen. Residual Disease (RD) is d
Interventions
- DRUG Trastuzumab
- DRUG Paclitaxel
- DRUG 5-fluorouracil
- DRUG Pertuzumab
- DRUG Epirubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2013-09 |
| Est. Completion | 2018-08 |
| Phase | Phase 2 |
What the finished NCT01855828 record still lists
NCT01855828 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 5 interventions - of which Trastuzumab is the first listed.
NCT01855828 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01855828 about?
NCT01855828 is a clinical study titled "Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer". The main goal of this clinical trial is to test if adding pertuzumab (Perjeta), improves the anticancer activity of the combination chemotherapy regimen of trastuzumab (Herceptin) concomitant with paclitaxel, 5-fluorouracil, epirubicin, and cyclophosphamide (T-FEC). The study will also test the safe...
What is the current status of trial NCT01855828?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2013-09. Estimated completion is 2018-08.
What interventions are being tested in trial NCT01855828?
The interventions under investigation include: Trastuzumab (DRUG), Paclitaxel (DRUG), 5-fluorouracil (DRUG), Pertuzumab (DRUG), Epirubicin (DRUG).
Who is sponsoring clinical trial NCT01855828?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01855828'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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