A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Early Breast Cancer

Treatments: Biological: PF-05280014; Drug: Paraplatin®; Biological: Trastuzumab-EU; Drug: Taxotere®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02187744

REFLECTIONS B327-04

REFLECTIONS (B327-04) (Other Identifier)

2013-004679-11 (EudraCT Number)

B3271004

Details and patient eligibility

About

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) approved in the EU in combination with Taxotere® and Carboplatin (Paraplatin) in patients with operable HER2 positive, breast cancer in the neoadjuvant setting. The hypothesis to be tested in this study is the percentage of patients with steady state Cycle 5 Ctrough (Cycle 6 pre-dose) >20 µg/mL of trastuzumab-Pfizer is similar to EU-approved trastuzumab, using a margin of -12.5%.

Enrollment: 226 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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226 participants in 2 patient groups

PF-05280014

Experimental group

Treatment:

Drug: Taxotere®

Biological: PF-05280014

Drug: Taxotere®

Drug: Paraplatin®

Drug: Paraplatin®

Herceptin®

Active Comparator group

Treatment:

Biological: Trastuzumab-EU

Drug: Taxotere®

Drug: Taxotere®

Drug: Paraplatin®

Drug: Paraplatin®