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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)

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, 92708 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Early Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02187744
Pfizer
Completed
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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A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)
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%.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Early Breast Cancer
  • Biological: PF-05280014
    Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum of 6 cycles.
  • Drug: Taxotere®
    Injection concentrate single-dose vials containing 20 mg (0.5 mL) or 80 mg (2 mL), each mL contains 40 mg docetaxel (anhydrous) and 1040 mg polysorbate 80, The starting dose of Taxotere® (docetaxel) will be 75 mg/m2 administered intravenously over 60 minutes every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.
    Other Name: docetaxel
  • Drug: Paraplatin®
    Lyophilized powder, single-dose vials containing 50 mg, 150 mg, and 450 mg of Carboplatin for administration by intravenous infusion (each vial contains equal parts by weight of Carboplatin and mannitol), starting dose 6 AUC, over 15 minutes or longer every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.
    Other Name: carboplatin
  • Biological: Trastuzumab-EU
    Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum 6 cycles.
  • Experimental: PF-05280014
    Interventions:
    • Biological: PF-05280014
    • Drug: Taxotere®
    • Drug: Paraplatin®
  • Active Comparator: Herceptin®
    Interventions:
    • Biological: Trastuzumab-EU
    • Drug: Taxotere®
    • Drug: Paraplatin®
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
226
March 9, 2016
March 9, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belarus,   Czech Republic,   Hungary,   Italy,   Poland,   Russian Federation,   Serbia,   Slovakia,   Ukraine,   United States
 
 
NCT02187744
B3271004
REFLECTIONS B327-04
2013-004679-11 ( EudraCT Number )
REFLECTIONS (B327-04) ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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1-800-718-1021

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