Neoadjuvant Phase II Trial in Patients With T1c Operable, HER2-positive Breast Cancer According to TOP2A Status

Summary

The main objective of this multicenter study will therefore be to evaluate pathologic complete response rates of an anthracycline-based regimen \[FEC 100 - TAXOTERE® - HERCEPTIN® - PERTUZUMAB\] and a non anthracycline-based regimen \[TAXOTERE® - CARBOPLATINE - HERCEPTIN® - PERTUZUMAB\] according to the presence or not of TOP2A gene amplification in a population of breast cancer patients with HER2 overexpression. A very important objective of the study will be the evaluation of biomarkers that predict response to treatment.

Timeline

Start

2015-01

Primary completion

2019-10-07

Completion

2024-07-08

Publications

• Ginzac A, Molnar I, Durando X, Motte Rouge T, Petit T, D'hondt V, Campone M, Bonichon-Lamichhane N, Venat Bouvet L, Levy C, Augereau P, Pistilli B, Arsene O, Jouannaud C, Nguyen S, Cayre A, Tixier L, Mahier Ait Oukhatar C, Nabholtz JM, Penault-Llorca F, Mouret-Reynier MA. Neoadjuvant anthracycline-based (5-FEC) or anthracycline-free (docetaxel/carboplatin) chemotherapy plus trastuzumab and pertuzmab in HER2 + BC patients according to their TOP2A: a multicentre, open-label, non-randomized phase II trial. Breast Cancer Res Treat. 2024 Jun;205(2):267-279. doi: 10.1007/s10549-024-07285-y. Epub 2024 Mar 7.

Drugs

Indications