Condition: Breast Cancer Metastatic · HER2-positive Metastatic Breast Cancer · HER2 Low Breast Carcinoma · Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
ICARUS-BREAST02 is an open-label, multicenter, phase 1b/2, platform study that aims to evaluate the safety, tolerability, and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC. The first 2 modules will evaluate: i. safety and efficacy of HER3-DXd with olaparib in patients with HER2-low and HER2-positive ABC progressed on T-DXd (Module 1) and HER3-DXd monotherapy in patients with HER2-low ABC progressed on T-DXd (Module 0). The main objective of Part 1 is to assess the safety and tolerability of HER3-DXd monotherapy and combination and to determine the recommended phase 2 dose (RP2D) of the combination containing HER3-DXd. The main objective of Part 2 is to assess the efficacy of study therapies in each module based on investigator assessment as evaluated by the objective response rate (ORR) at 6 months.
This description comes directly from the study's public registry record.
Barbara Pistilli · +33 (0)1 42 11 61 62 · barbara.pistilli@gustaveroussy.fr
Fernanda Mosele · +33 (0)1 42 11 61 43 · Mariafernanda.MOSELE@gustaveroussy.fr
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| Gustave Roussy Institut | Villejuif, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06298084