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NeoTOP: Neoadjuvant therapy for HER2-positive breast cancer based on TOP2A status

NCT02339532Phase 2

Key facts

Status: Completed
Start: Jan 2015
Primary completion: Oct 2019
Countries: 1
Sponsor: Unicancer
Modality: Monoclonal Antibodies

Drugs: pertuzumab
Conditions: breast cancer

Overview

Phase 2, open-label trial of pertuzumab in breast cancer (2 arms), sponsored by Unicancer. Primary endpoint: Pathological complete response according to Chevallier classification at 20 weeks. Started Jan 2015; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

TOP2A Amplified Arm
FEC100 followed by Docetaxel + Trastuzumab + Pertuzumab
TOP2A Not Amplified Arm
Docetaxel + Carboplatin + Trastuzumab + Pertuzumab (TCHP)

Who it enrols

Women with HER2-positive breast cancer (T1c-T4a), HR-negative (except for T1c where HR can be positive), and known TOP2A status.

Endpoints

Primary

Pathological complete response according to Chevallier classification20 weeks

Secondary

Predictive factors of response to both treatment regimens20 weeks
Pathological complete response according to Sataloff classification20 weeks
Clinical and radiological response according to the WHO criteria20 weeks
Toxicity according to NCI CTC-AE v4.0 criteria20 weeks
Progression-free survival60 months
Overall survival60 months

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