A Randomized, Double-blind Pharmacokinetic Study of PF-05280014 Plus Taxotere and Carboplatin Versus Herceptin Plus Taxotere And Carboplatin For The Neoadjuvant Treatment Of Patients With Operable HER2-Positive Breast Cancer - REFLECTIONS B327-04

Pfizer Inc0 sites220 target enrollmentMay 29, 2014

DrugsHerceptin®

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Pfizer Inc
Enrollment: 220
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 29, 2014

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Pfizer Inc

Eligibility Criteria

Inclusion Criteria

•1\. Female patients aged 18 years or older.
•2\. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legal representative) has been informed of all pertinent aspects of the study.
•3\. Histologically confirmed HER2 overexpressing invasive breast cancer.
•4\. Plan for definitive surgical resection of breast tumor (ie, lumpectomy or mastectomy, and sentinel node (SN) biopsy or axillary lymph node dissection (ALND).
•5\. Plan for neoadjuvant chemotherapy.
•6\. Documentation of HER2 gene amplification or overexpression by one of the following:
•Gene amplification by fluorescent in\-situ hybridization (FISH) chromogenic in\-situ hybridization (CISH); or dual in\-situ hybridization (DISH) (as defined by the manufacturer's kit instruction); OR
•Overexpression by immunohistochemistry (IHC) categorized as IHC3\+; OR
•Overexpression by immunohistochemistry categorized as IHC2\+ with FISH, CISH, or DISH confirmation.
•Determination of HER2 positive status using one of the Sponsor approved analytical test methods listed in the Case Record Form

Exclusion Criteria

•1\. Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Pfizer employees directly involved in the conduct of the trial.
•2\. Bilateral breast cancer.
•3\. Inflammatory breast cancer.
•4\. Presence of known distant metastases (determined by principal investigator).
•5\. Received prior treatment, including chemotherapy, endocrine therapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer.
•6\. Other concomitant active malignancy or history of malignancy in the past 5 years except treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
•7\. Pre\-existing clinically significant (\= grade 2\) peripheral neuropathy.
•8\. Any history of documented or current congestive heart failure, current high\-risk uncontrolled arrhythmias, current angina pectoris requiring a medicinal product, current clinically significant valvular disease, current evidence of transmural infarction on electrocardiogram (ECG), or current poorly controlled hypertension.
•9\. Severe dyspnea at rest requiring supplementary oxygen therapy.
•10\. Known or demonstrated viral infection as listed below. Testing to demonstrate eligibility is required only in countries where regulations mandate testing. In all other countries, testing should be considered if a patient is at risk for having undiagnosed infection (for