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NCT01276041 · ClinicalTrials.gov registry record · Phase 2
Paclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 6
- Study locations
NCT01276041: Completed Phase 2 study of Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01276041 is a Phase 2 study of Breast Cancer that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 70 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 6 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01276041, a Phase 2 study of Breast Cancer, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to see if a combination of drugs can help to treat this type of cancer. One drug is a chemotherapy agent called paclitaxel (Taxol®). Paclitaxel will be given every week through the vein. Although the weekly schedule of paclitaxel is not included in the label, the schedule and dose of weekly paclitaxel have been studied and have been proven to be more effective than an old standard schedule. The other two work against HER2. One is called trastuzumab (Herceptin®) and it is commonly given to women with early HER2 positive breast cancer or with advanced HER2 positive breast cancer that has spread to other parts of the body. Trastuzumab will be given through the vein every 3 weeks (or every week at the doctor's discretion). The third drug, pertuzumab, is an investigational drug. It has not been approved by the Food and Drug Administration. It has been given in studies to over 800 people. It has been effective in treating HER2 positive breast cancer. Pertuzumab will be given every 3 weeks through the vein. This study is looking at the effectiveness of these three drugs together.
Primary Outcome
Patients who are considered progression-free at 6 months are deemed successes. Failures are those patients who progressed before the 6 month mark. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Conditions Studied
Interventions
- DRUG pertuzumab in combination with trastuzumab and paclitaxel
Study Locations (6)
New York
- Memorial Sloan Kettering Cancer Center @ Suffolk - Commack
- Memorial Sloan Kettering West Harrison - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering at Mercy Medical Center - Rockville Centre
New Jersey
- Memorial Sloan Kettering at Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Monmouth - Middletown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2011-01-05 |
| Est. Completion | 2019-08-07 |
| Phase | Phase 2 |
What the finished NCT01276041 record still lists
NCT01276041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which pertuzumab in combination with trastuzumab and paclitaxel is the first listed.
NCT01276041 lists 6 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT01276041 about?
NCT01276041 is a clinical study titled "Paclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer". The purpose of this study is to see if a combination of drugs can help to treat this type of cancer. One drug is a chemotherapy agent called paclitaxel (Taxol®). Paclitaxel will be given every week through the vein. Although the weekly schedule of paclitaxel is not included in the label, the schedul...
What is the current status of trial NCT01276041?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2011-01-05. Estimated completion is 2019-08-07.
What conditions does trial NCT01276041 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01276041?
The interventions under investigation include: pertuzumab in combination with trastuzumab and paclitaxel (DRUG).
Who is sponsoring clinical trial NCT01276041?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01276041 being conducted?
This trial has 6 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01276041's enrollment target sits among peer trials
70 696th of 1224 higher than 521 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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