NCT05831878 RC48-ADC in HER2-low Advanced Breast Cancer
| NCT ID | NCT05831878 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Advanced Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-05-04 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2023-05-04 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Female patients aged ≥18 years * Expected survival ≥12 weeks * ECOG 0-1 * Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable * At least one measurable lesion according to the RECIST 1.1 * No history of antibody-drug conjugate use * Up to one previous chemotherapy for advanced disease * Available hormone receptor status. Hormone receptor-positive subjects are allowed to receive no more than two previous endocrine therapy for advanced disease * HER2-low tumors, defined as IHC1+ or IHC2+ with negative FISH test; or HER2-ultralow tumors, defined as incomplete and faint membrane staining in \>0 but ≤10% of tumor cells * Adequate organ function Exclusion Criteria: * History of thromboembolic events * Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc. * Active infections requiring systemic treatment * Pregnant or lactating * Presence of brain metastases and/or carcinomatous meningitis
Contact & Investigator
Wenjin Yin, M.D.
PRINCIPAL INVESTIGATOR
Renji Hospital,School of Medicine, Shanghai Jiaotong University
Frequently Asked Questions
Who can join the NCT05831878 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Advanced Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05831878 currently recruiting?
Yes, NCT05831878 is actively recruiting participants. Contact the research team at yinwenjin@renji.com for enrollment information.
Where is the NCT05831878 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05831878 clinical trial?
NCT05831878 is sponsored by RenJi Hospital. The principal investigator is Wenjin Yin, M.D. at Renji Hospital,School of Medicine, Shanghai Jiaotong University. The trial plans to enroll 36 participants.
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