Trials / Recruiting
RecruitingNCT05831878
RC48-ADC in HER2-low Advanced Breast Cancer
Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- RenJi Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.
Detailed description
Subjects with HER2-low advanced breast cancer were treated with Disitamab vedotin as salvage treatment. ORR, PFS, OS and AE were assessed during the trial. HER2-low status is defined as IHC1+ or IHC2+ with negative FISH test.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Disitamab vedotin | 2.0mg/kg, iv, day1, every 2 weeks |
Timeline
- Start date
- 2023-05-04
- Primary completion
- 2026-03-01
- Completion
- 2026-08-01
- First posted
- 2023-04-26
- Last updated
- 2025-11-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05831878. Inclusion in this directory is not an endorsement.