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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02187744 |
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Date of registration:
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30/06/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)
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Scientific title:
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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 |
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Date of first enrolment:
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September 23, 2014 |
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Target sample size:
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226 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02187744 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Belarus
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Czech Republic
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Czechia
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Hungary
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Italy
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Poland
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Russian Federation
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Serbia
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Slovakia
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Ukraine
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Early Breast Cancer
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Intervention(s)
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Biological: PF-05280014
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Biological: Trastuzumab-EU
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Drug: Taxotere®
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Drug: Paraplatin®
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Primary Outcome(s)
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Percentage of Participants With Steady State Drug Concentration Ctrough (Cycle 6 Pre-dose) >20 µg/mL at Cycle 5.
[Time Frame: Cycle 5]
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Secondary Outcome(s)
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Pathologic Complete Response (pCR) Defined as the Absence of Invasive Neoplastic Cells in the Breast and Lymph Nodes.
[Time Frame: Cycle 6/End of treatment]
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Incidence of Neutralizing Antibodies (NAb) at Cycles 1 Through 6.
[Time Frame: Cycles 1 through 6]
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Mean Predose Trastuzumab-Pfizer and Trastuzumab-EU Concentrations at Cycles 1 Through 6.
[Time Frame: Cycles 1 through 6]
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Incidence of Anti-trastuzumab Antibodies (ADAs) at Cycles 1 Through 6.
[Time Frame: Cycles 1 through 6]
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Objective Response Rate (ORR) Defined as the Percentage of Participants Having Complete or Partial Response at End of Treatment, Based on Radiographic Assessments of the Tumor.
[Time Frame: Cycle 6/End of treatment]
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Secondary ID(s)
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2013-004679-11
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REFLECTIONS (B327-04)
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B3271004
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REFLECTIONS B327-04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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