Trial intelligence / Profile preview

Perjeta with Herceptin and Chemotherapy in HER2-positive Breast Cancer

NCT02132949Phase 2

Key facts

Status: Completed
Start: Jul 2014
Primary completion: Mar 2016
Countries: 12
Sponsor: Roche
Modality: Monoclonal Antibodies

Drugs: pertuzumab
Conditions: breast cancer

Overview

Phase 2, open-label trial of pertuzumab in breast cancer (2 cohorts), sponsored by Roche. Primary endpoints: Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Neoadjuvant Treatment Period up to 25 weeks and Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline During the Neoadjuvant Treatment Period up to 25 weeks. Started Jul 2014; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

Cohort A: ddAC -> Paclitaxel+P+H
Dose-dense AC followed by Paclitaxel with Pertuzumab and Trastuzumab
Cohort B: FEC -> Docetaxel+P+H
FEC followed by Docetaxel with Pertuzumab and Trastuzumab

Who it enrols

Patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer, LVEF >= 55%, and no prior systemic therapy.

Endpoints

Primary

Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Neoadjuvant Treatment Periodup to 25 weeks
Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline During the Neoadjuvant Treatment Periodup to 25 weeks

Secondary

Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Adjuvant Treatment Periodup to 39 weeks
Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline During the Adjuvant Treatment Periodup to 39 weeks
Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Treatment-Free Follow-Up Periodup to 5 years
Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline During the Treatment-Free Follow-Up Periodup to 5 years
Overview of the Number of Participants With at Least One Adverse Eventup to 5 years
Percentage of Participants Positive for Anti-Therapeutic Antibodies (ATAs) to Pertuzumabup to 15 months
Percentage of Participants With Total Pathologic Complete Response (tpCR)up to 25 weeks
Percentage of Participants With Clinical Response According to RECIST v1.1up to 24 weeks

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