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

Status:	Completed
Conditions:	Breast Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	1/10/2019
Start Date:	September 23, 2014
End Date:	March 9, 2016

A RANDOMIZED, DOUBLE-BLIND PHARMACOKINETIC STUDY OF PF-05280014 PLUS TAXOTERE (REGISTERED) AND CARBOPLATIN VERSUS HERCEPTIN (REGISTERED) PLUS TAXOTERE (REGISTERED) AND CARBOPLATIN FOR THE NEOADJUVANT TREATMENT OF PATIENTS WITH OPERABLE HER2-POSITIVE BREAST CANCER

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%.

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.

We found this trial at

sites

Millennium Oncology (Imaging Facility)

Kingwood, Texas 77339

from

Kingwood, TX