Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments 5-fluorouracil, cyclophosphamide, docetaxel, doxorubicin, epirubicin, paclitaxel, pertuzumab [perjeta], trastuzumab [herceptin]
Phase phase 2
Targets HER2, HER
Sponsor Hoffmann-La Roche
Start date July 2014
End date November 2020
Trial size 400 participants
Trial identifier NCT02132949, WO29217

Summary

This multicenter, non-randomized, open-label, phase II study is designed to evaluate the safety and efficacy of Perjeta in combination with Herceptin and anthracycline-based chemotherapy as neoadjuvant treatment in patients with HER2-based locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a treatment regimen (A or B) for all their patients to follow. Treatment A (Cohort A): Patients will first be given doxorubicin (60 mg/m2 IV) and cyclophosphamide (600 mg/m2 IV). This will be followed by administration of paclitaxel (80 mg/m2 IV), Perjeta (420 mg IV) and Herceptin (6 mg IV) for four cycles. Treatment B (Cohort B): Patients will first receive 5-fluorouracil (500 mg/m2 IV), epirubicin (100 mg/m2 IV), and cyclophosphamide (600 mg/m2 IV). This is to be followed by docetaxel (100 mg/m2 IV), Perjeta (420 mg IV) and Herceptin (6 mg IV) treatment for four cycles. Patients in both cohorts will subsequently undergo surgical treatment and then resume Perjeta and Herceptin treatment. Total time on treatment is expected to last 1 year; patients will be followed-up for a further 4 years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
cyclophosphamide
600 mg/m2 IV given every 2 weeks for 8 weeks (Cycles 1-4)
doxorubicin
60 mg/m2 IV given every 2 weeks for 8 weeks (Cycles 1-4)
paclitaxel
80 mg/m2 IV given weekly for 12 weeks (Cycles 5-8)
pertuzumab [perjeta]
420 mg (840 mg first dose) IV given every 3 weeks for 17 cycles
trastuzumab [herceptin]
6 mg/kg (8 mg/kg first dose) IV given every 3 weeks for 17 cycles
(Experimental)
5-fluorouracil
500 mg/m2 IV given every 3 weeks for 12 weeks (Cycles 1-4)
cyclophosphamide
600 mg/m2 IV given every 3 weeks for 12 weeks (Cycles 1-4)
docetaxel
100 mg/m2 (75 mg/m2 first dose) IV given every 3 weeks for 12 weeks (Cyles 5-8)
epirubicin
100 mg/m2 IV given every 3 weeks for 12 weeks (Cycles 1-4)
pertuzumab [perjeta]
420 mg (840 mg first dose) IV given every 3 weeks for 17 cycles
trastuzumab [herceptin]
6 mg/kg (8 mg/kg first dose) IV given every 3 weeks for 17 cycles

Primary Outcomes

Measure
Incidence of cardiac events as assessed by the investigator using National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) v. 4.0
time frame: Approximately 5 years
Changes in left ventricular ejection fraction assessed by ECHO or MUGA scan.
time frame: Approximately 5 years

Secondary Outcomes

Measure
Incidence of adverse events
time frame: Approximately 5 years
Incidence of anti-therapeutic antibodies to Perjeta
time frame: Approximately 5 years
Total pathological complete response defined as the eradication of invasive disease according to pathologist assessment
time frame: Approximately 5 years
Clinical response as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) v. 1.1
time frame: Approximately 5 years
Event-free survival defined as time from enrollment to first occurrence of progressive disease, relapse, or death from any cause.
time frame: Approximately 5 years
Invasive disease-free survival defined as the time from the first date of no disease to the first documentation of progressive invasive disease, relapse, or death from any cause.
time frame: Approximately 5 years
Overall survival, defined as the time from enrollment to death from any cause.
time frame: Approximately 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age >/= 18 years - Male and female patients with locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer. Patients with inflammatory breast cancer must be able to have a core needle biopsy. - Primary tumor > 2 cm in diameter, or > 5 mm in diameter and node-positive - HER2-positive breast cancer confirmed by a central laboratory - Availability of tumor tissue specimen - Baseline left ventricular ejection fraction (LVEF) >/= 55% - Eastern Cooperative Oncology Group (ECOG) performance status 10 mg methylprednisolone or equivalent [excluding inhaled steroids]).

Additional Information

Official title A Multicenter, Multinational, Phase II Study to Evaluate Pertuzumab in Combination With Trastuzumab and Standard Neoadjuvant Anthracycline-based Chemotherapy in Patients With HER2-Positive, Locally Advanced, Inflammatory, or Early-Stage Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.
Location data was received from the National Cancer Institute and was last updated in August 2016.