Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wcześniejsze leczenie lekiem T-DXd z progresją choroby w jego trakcie lub krótko po zakończeniu
- •Rak piersi HER2-dodatni z wcześniejszym leczeniem trastuzumabem i taksanami
- •Lub rak piersi z niskim HER2 leczony wcześniej taksanami, z receptorem hormonalnym dodatnim i leczeniem hormonalnym z inhibitorem CDK4/6
- •Wiek od 18 lat
- •Potwierdzony histologicznie nieoperacyjny lub przerzutowy rak piersi
- •Dobry stan sprawności (ECOG ≤1)
- •Co najmniej jedna zmiana możliwa do oceny radiologicznej
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- March 29, 2024
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Gustave Roussy Institut
Villejuif, France
Trial contact
Barbara Pistilli
Fernanda Mosele
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.