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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)

NCT02187744

Description:

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%.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02187744

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: B3271004
  • SECONDARY ID: REFLECTIONS B327-04
  • SECONDARY ID: 2013-004679-11
  • SECONDARY ID: REFLECTIONS (B327-04)
  • NCT ID: NCT02187744

Conditions

  • Early Breast Cancer

Interventions

DrugSynonymsArms
PF-05280014PF-05280014
Taxotere®docetaxelPF-05280014
Paraplatin®carboplatinPF-05280014
Trastuzumab-EUHerceptin®
Taxotere®docetaxelHerceptin®
Paraplatin®carboplatinHerceptin®

Purpose

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%.

Trial Arms

NameTypeDescriptionInterventions
PF-05280014Experimental
  • PF-05280014
  • Taxotere®
  • Paraplatin®
Herceptin®Active Comparator
  • Trastuzumab-EU
  • Taxotere®
  • Paraplatin®

Eligibility Criteria

        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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of Participants With Steady State Drug Concentration Ctrough (Cycle 6 Pre-dose) >20 µg/mL at Cycle 5.
Time Frame:Cycle 5
Safety Issue:
Description:The percentage of participants with Cycle 5 Ctrough (Cycle 6 pre-dose) >20 μg/mL in each treatment group, the denominator being the number of participants in the per protocol population for each treatment group.

Secondary Outcome Measures

Measure:Mean Predose Trastuzumab-Pfizer and Trastuzumab-EU Concentrations at Cycles 1 Through 6.
Time Frame:Cycles 1 through 6
Safety Issue:
Description:Samples of blood were taken pre-dose on Cycles 1, 2, 4, 5, and 6, and at 1 hour post dose on Cycles 1 and 5 for pharmacokinetic evaluation.
Measure: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
Safety Issue:
Description:Following surgery after treatment completion, tumors were assessed as Complete Pathological Response, Partial Pathological Response, or No Pathological Response.
Measure: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
Safety Issue:
Description:ORR was defined as Complete Response (CR), Partial Response (PR), Stable (SD), Progressive Disease (PD) or Indeterminate (IND). ORR was the percentage of participants who had CR or PR at Cycle 6/End of treatment.
Measure:Incidence of Anti-trastuzumab Antibodies (ADAs) at Cycles 1 Through 6.
Time Frame:Cycles 1 through 6
Safety Issue:
Description:The number of participants with positive (titer >=1.00) pre-dose ADA samples, participants counted towards the total if for at least one sample, the ADA was positive.
Measure:Incidence of Neutralizing Antibodies (NAb) at Cycles 1 Through 6.
Time Frame:Cycles 1 through 6
Safety Issue:
Description:The number of participants with positive (NAb response >=1.48) pre-dose NAb samples, participants counted towards the total if for at least one sample, the NAb was positive.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Pfizer

Trial Keywords

  • Biosimilars
  • Non-inferiority
  • Neoadjuvant Setting
  • Early Breast Cancer
  • PK
  • Phase 3
  • Trastuzumab
  • Herceptin
  • HER2 Positive

Last Updated

January 8, 2019