Trials / Completed
CompletedNCT04132960
Study of DS-8201a, an Antibody Drug Conjugate for Advanced Breast Cancer Patients, With Biomarkers Analysis
Phase II, Open Label Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC) for Advanced Breast Cancer Patients, With Biomarkers Analysis to Characterize Response/Resistance to Therapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 186 (actual)
- Sponsor
- UNICANCER · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Multicenter, open-label phase II trial assessing the efficacy of DS-8201a monotherapy in patients with metastatic breast cancer.
Detailed description
The main objective is to evaluate the anti-tumor activity of DS-8201a in three cohorts of advanced breast cancer patients: * Cohort 1: HER2 over-expressing (HER2 IHC3+ or HER2 IHC2+/ISH+) * Cohort 2: HER2 low-expressing (IHC1+ or IHC2+/ISH-) * Cohort 3: HER2 non-expressing (IHC0+)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DS-8201a | Anti-HER2-antibody drug conjugate (ADC) |
Timeline
- Start date
- 2019-10-21
- Primary completion
- 2021-10-29
- Completion
- 2024-12-26
- First posted
- 2019-10-21
- Last updated
- 2025-06-12
Locations
15 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04132960. Inclusion in this directory is not an endorsement.