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HER2 Positive Metastatic Breast Cancer / Patritumab deruxtecan / Breast Cancer Metastatic · Phase 1/2 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
ICARUS-BREAST02 is a planned open-label, multicenter Phase 1b/2 study of patritumab deruxtecan (HER3-DXd) monotherapy and in combination with olaparib in patients with advanced breast cancer who have progressed on T-DXd. This registry record describes the study protocol only; no efficacy or safety results have been posted.
Phase 1/2, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Breast Cancer Metastatic, HER2-positive Metastatic Breast Cancer, HER2 Low Breast Carcinoma, Advanced Breast Cancer; age from 18 Years. Intervention: Part 1a (safety run-in module 0); Part 1b (dose finding module 1 + dose expansion module 0); Part 2 (dose expansion module 1 + module 0). n = 152. 1 site: France.
ICARUS-BREAST02 is a planned open-label, multicenter Phase 1b/2 study of patritumab deruxtecan (HER3-DXd) monotherapy and in combination with olaparib in patients with advanced breast cancer who have progressed on T-DXd. This registry record describes the study protocol only; no efficacy or safety results have been posted.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This registry record cannot guide current practice, as results are not yet available. Clinicians should monitor for publication of Part 1 safety data (due ~21 months from enrollment start) and Part 2 efficacy results (due ~51 months) to assess whether HER3-DXd offers a new option for T-DXd–refractory disease.
This is a clinical trial registry record describing a planned Phase 1b/2 study with no results posted; it documents the study design and planned outcomes only.
As stated by the source record.
Quoted from the source exactly as published.
This registry record cannot guide current practice, as results are not yet available. Clinicians should monitor for publication of Part 1 safety data (due ~21 months from enrollment start) and Part 2 efficacy results (due ~51 months) to assess whether HER3-DXd offers a new option for T-DXd–refractory disease.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06298084). This is a study registration, not published results. Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 152 participants (ESTIMATED). Conditions: Breast Cancer Metastatic, HER2-positive Metastatic Breast Cancer, HER2 Low Breast Carcinoma, Advanced Breast Cancer. Interventions: DRUG: Patritumab deruxtecan; DRUG: Olaparib. Primary outcome measures: DLTs (dose-limiting toxicity) for part 1a and 1b , 21 months after the beginning of enrolment; Frequency of safety event for part 1a and 1b , 21 months after the beginning of enrolment; Severity of safety event for part 1a and 1b , 21 months after the beginning of enrolment; Proportion of treatment modification due to AEs for part 1a and 1b , 21 months after the beginning of enrolment; frequency of laboratory abnormalities for part 1a and 1b , 21 months after the beginning of enrolment; Severity of laboratory abnormalities for part 1a and 1b , 21 months after the beginning of enrolment; radiographic changes potentially consistent with ILD/pneumonitis or any other pulmonary signs/symptoms for part 1a and 1b , 21 months after the beginning of enrolment; ORR for part 2 , 51 months; DOR for part 2 , 51 months; PFS for part 2 , 51 months; CBR for part 2 , 51 months. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.