Status:
ACTIVE_NOT_RECRUITING
Paclitaxel + Trastuzumab + Pertuzumab as Pre-Op for Inflammatory BrCa
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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, pacl...
Detailed Description
If you agree to take part in this study we will ask you to undergo some screening tests and procedures to confirm that you are eligible. Many of these tests and procedures are likely to be part of reg...
Eligibility Criteria
Inclusion
- Histologically confirmed invasive breast cancer
- HER2 positive breast cancer
- Clinical diagnosis of inflammatory breast cancer
- Without evidence of visceral or bone involvement with metastatic cancer on physical exam or any diagnostic study. Extensive nodal involvement is allowed
- Willingness to undergo a research biopsy of the affected breast
Exclusion
- Prior therapy for the treatment of breast cancer
- Receiving any other investigational or commercial agents or therapies
- Known brain metastases
- Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, trastuzumab, pertuzumab
- Uncontrolled intercurrent illness
- Pregnant or breastfeeding
- History of a different malignancy except for the following circumstances: disease-free for at least 5 years and at low risk of recurrence, or cervical cancer in situ or basal or squamous cell carcinoma of the skin
- HIV positive on combination anti-retroviral therapy
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2025
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01796197
Start Date
August 1 2013
End Date
November 1 2025
Last Update
August 7 2025
Active Locations (3)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
3
University of Michigan
Ann Arbor, Michigan, United States, 48109