A Study of PF-05280014 [Trastuzumab-Pfizer] or Herceptin® [Trastuzumab-EU] Plus Paclitaxel in HER2 Positive First Line Metastatic Breast Cancer Treatment

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/07/004786
• Date of registration: 30-07-2014
• Prospective Registration: Yes
• Primary sponsor: Pfizer Limited
• Public title: A Study of PF-05280014 [Trastuzumab-Pfizer] or Herceptin® [Trastuzumab-EU] Plus Paclitaxel in HER2 Positive First Line Metastatic Breast Cancer Treatment
• Scientific title: A phase 3 randomized, double-blind study of PF-05280014 plus paclitaxel versus trastuzumab plus paclitaxel for the first-line treatment of patients with HER2-positive metastatic breast cancer - RACE
• Date of first enrolment: 01-08-2014
• Target sample size: 690
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9661
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, Chile, Czech Republic, Greece, Hungary, India, Japan, Mexico, Peru, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Serbia , South Africa, Spain, Thailand, Turkey, Ukraine, United States of America

Contacts

• Name: Dr Seema Pai
• Affiliation: Pfizer Limited

• Name: Dr Seema Pai
• Affiliation: Pfizer Limited

Key inclusion & exclusion criteria

Inclusion criteria: •Female patients aged 18 years or older.

•Histologically confirmed diagnosis of breast cancer.

•Presence of metastatic disease.

•Prior documentation of HER2 gene amplification or overexpression. Determination of HER2 positive status using one of the Sponsor accepted analytical test.

•Available tumor tissue for central review of HER2 status.

•At least 1 measurable lesion as defined by RECIST 1.1.

•Eastern Cooperative Oncology Group status of 0 to 2.

•Left ventricular ejection fraction within institutional range of normal, measured by either two dimensional echocardiogram or multigated acquisition scan.


Exclusion criteria: •Relapse within 1 year of last dose of previous adjuvant (including neoadjuvant) treatment.

•Prior systemic therapy for metastatic disease (except endocrine therapy).

•Prior cumulative dose of doxorubicin of more than 400 mg per m2, epirubicin dose more than 800 mg per m2, or the equivalent dose for other anthracyclines or derivatives (eg, 72 mgper m2 of mitoxantrone). If the patient has received more than one anthracycline, then the cumulative dose must not exceed the equivalent of 400 mg per m2 of doxorubicin.

•Inflammatory breast cancer.

•Active uncontrolled or symptomatic central nervous system metastases.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Metastatic Breast Cancer

Intervention(s)

Intervention1: PF-05280014: On treatment days when both PF-05280014 and paclitaxel are administered, the order of administration should be PF-05280014 infusion, followed by paclitaxel infusion.
During the period in which PF-05280014 is administered in combination with paclitaxel, and until at least Week 33 of the study, PF-05280014 will be administered in a weekly regimen on Days 1, 8, 15 and 22 of each 28-day cycle. The first administration on Day 1, Cycle 1 will be a loading dose of 4 mg/kg infused over 90 minutes. Subsequent weekly infusions will be 2 mg/kg administered over 30 to 90 minutes depending on tolerability. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 regimen may be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
Treatment of individual patients with PF-05280014 well beyond Week 53 of the study is expected to be common.

Intervention2: Paclitaxel: Paclitaxel will be administered in a â??weeklyâ?? regimen, on Days 1, 8 and 15 of each 28-day cycle (ie, no paclitaxel is administered on Day 22 of each cycle).
The starting dose of paclitaxel will be 80 mg/m2 by IV infusion over 60 minutes.
Depending on observed toxicity attributed to paclitaxel, provision is made for dose reduction to 70 mg/m2 and then 60 mg/m2 as needed. In the absence of disease progression in the judgment of the investigator or prohibitive toxicity, patients will receive treatment with paclitaxel for at least 6 cycles or until maximal benefit of response is obtained.

Control Intervention1: Herceptin®: On treatment days when both trastuzumab and paclitaxel are administered, the order of administration should be tra

Primary Outcome(s)

Percentage of Participants With Objective Response Rate (ORR)

The percent of patients within each treatment group that achieved Complete Response (CR) or Partial Response (PR) by Week 25 of the study (window ± 14 days) and confirmed on a follow-up assessment, in accordance with the RECIST 1.1.

Timepoint: Week 25

Secondary Outcome(s)

Duration of Response (DOR)

The time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of Progressive Disease (PD) or to death due to any cause in the absence of documented PD.

Timepoint: up to 12 months

Incidence of ADA

The percentage of patients with positive ADA and neutralizing antibodies will be summarized for each treatment arm.

Timepoint: up to 24 months

1-year Progression-Free Survival (PFS) Rate

The time from date of randomization to first progression of disease (PD) or death due to any cause in the absence of documented PD.

Timepoint: up to 12 months

Minimum Observed Plasma Trough Concentration (Cmin)

Trough PF-05280014 and trastuzumab-EU concentrations at selected cycles.

Timepoint: up to 24 months

1-year Survival Rate

Time from date of randomization to death due to any cause while the patient is on the study.

Timepoint: up to 12 months

Maximum Observed Plasma Concentration (Cmax)

Peak PF-05280014 and trastuzumab-EU concentrations at selected cycles.

Timepoint: up to 4 months

Secondary ID(s)

NCT01989676

B3271002, Protocol Amendment 1, dated 29 Jul 2013

Source(s) of Monetary Support

Pfizer Inc, 235 East 42nd Street, New York, NY 10017, United States of America

Ethics review

Status: Approved
Approval date: 12/12/2013
Contact:

Manipal University Ethics Committee

Status: Approved
Approval date: 23/12/2013
Contact:

Institutional Ethics Committee, King George Hospital

Status: Approved
Approval date: 07/01/2014
Contact:

Acharya Harihar Regional Cancer Centre Institutional Ethics Committee (AHRCC-IEC),

Status: Approved
Approval date: 30/01/2014
Contact:

Sahyadri Hospitals Ltd Ethics Committee

Status: Approved
Approval date: 03/02/2014
Contact:

Meenakshi Mission Hospital & Research Centre Institutional Ethics Committee

Status: Approved
Approval date: 21/02/2014
Contact:

Institutional Ethics Committee (IEC),(DMHRC),

Status: Approved
Approval date: 20/06/2014
Contact:

Ethics Committee of Manipal Hospitals (ECMH)

Status: Approved
Approval date: 23/09/2014
Contact:

Institutional Ethics Committee, Tata Memorial Hospital

Status: Approved
Approval date: 29/11/2014
Contact:

Shatabdi Hospital Ethics Committee (SHEC),

Status: Approved
Approval date: 20/02/2015
Contact:

Institutional Ethics Committee, P. D. Hinduja Hospital & RC