Status:
COMPLETED
A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)
Lead Sponsor:
Pfizer
Conditions:
Early Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014 (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus Herceptin® (Trastuzumab-EU...
Eligibility Criteria
Inclusion
- Histologically confirmed HER2 overexpressing invasive breast cancer.
- Plan for definitive surgical resection of breast tumor (i.e., lumpectomy or mastectomy, and sentinel node (SN) biopsy or axillary lymph node dissection (ALND).
- Plan for neoadjuvant chemotherapy.
- Measurable disease in the breast after diagnostic biopsy, defined as longest diameter ≥ 2.0 cm.
Exclusion
- Bilateral breast cancer.
- Inflammatory breast cancer.
- Presence of known distant metastases.
- Received prior treatment, including chemotherapy, endocrine therapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer.
Key Trial Info
Start Date :
September 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2016
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT02187744
Start Date
September 23 2014
End Date
March 9 2016
Last Update
January 8 2019
Active Locations (52)
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1
Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, United States, 92708
2
Millennium Oncology (Imaging Facility)
Kingwood, Texas, United States, 77339
3
Millennium Oncology (Imaging Facility)
Shenandoah, Texas, United States, 77380
4
Millennium Oncology
Shenandoah, Texas, United States, 77384