Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT07065435 for HER2 + Breast Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
RC48 Plus Bevacizumab or Pyrotinib in HER2-Positive Metastatic Breast Cancer After T-DXd Failure: A Phase II Study Phase 2 74 Randomized Overall Survival
Clinical Trial NCT07065435 is designed to study Treatment for HER2 + Breast Cancer. It is a Phase 2 interventional study that is recruiting, having started on 1 January 2024, with plans to enroll 74 participants. Led by The First Affiliated Hospital with Nanjing Medical University, it is expected to complete by 1 January 2026. The latest data from ClinicalTrials.gov was last updated on 15 July 2025.
Brief Summary
This multicenter, Phase II study (RADIANT-BC01) evaluates the efficacy and safety of Disitamab Vedotin (RC48) in combination with either bevacizumab or pyrotinib in adult patients with HER2-positive metastatic breast cancer whose disease has progressed on prior trastuzumab deruxtecan (T-Dxd) therapy.
Eligible participants will be randomized 1:1 to receive RC48 plus bevacizumab (7.5 mg/kg IV every 2 weeks) or RC48 pl...
Show MoreDetailed Description
Despite the remarkable benefits of trastuzumab deruxtecan (T-Dxd) as second-line therapy, resistance inevitably develops in HER2-positive metastatic breast cancer, and no standard treatment exists after T-Dxd failure. Disitamab Vedotin (RC48) is a novel antibody-drug conjugate (ADC) targeting HER2, with a cathepsin-cleavable linker and MMAE payload that has demonstrated encouraging antitumor activity and tolerability...Show More
Official Title
Efficacy and Safety of Disitamab Vedotin (RC48) in Combination With Bevacizumab or Pyrotinib in Patients With HER2-Positive Metastatic Breast Cancer After Trastuzumab Deruxtecan (T-DXd) Treatment Failure: A Phase II Study
Conditions
HER2 + Breast CancerOther Study IDs
- NJMU-BC07
NCT ID Number
Start Date (Actual)
2024-01-01
Last Update Posted
2025-07-15
Completion Date (Estimated)
2026-01-01
Enrollment (Estimated)
74
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Disitamab Vedotin (RC48)
Bevacizumab
Pyrotinib
Trastuzumab deruxtecan failure
Bevacizumab
Pyrotinib
Trastuzumab deruxtecan failure
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalRC48 + Bevacizumab Participants receive Disitamab Vedotin (RC48) at 2.0 mg/kg IV every 2 weeks plus Bevacizumab 7.5 mg/kg IV every 2 weeks. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or initiation of new anticancer therapy. | Disitamab Vedotin (RC48) A HER2-targeted antibody-drug conjugate comprising a humanized anti-HER2 monoclonal antibody linked via a cathepsin-cleavable MC-VC-PAB linker to the microtubule inhibitor MMAE (drug-to-antibody ratio ≈4). Administered intravenously at 2.0 mg/kg every 2 weeks. Bevacizumab A recombinant humanized monoclonal antibody that binds vascular endothelial growth factor (VEGF) to inhibit tumor angiogenesis. Administered intravenously at 7.5 mg/kg every 2 weeks in combination with RC48. |
ExperimentalRC48 + Pyrotinib Participants receive Disitamab Vedotin (RC48) at 2.0 mg/kg IV every 2 weeks plus Pyrotinib 320 mg orally once daily (post-meal). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or initiation of new anticancer therapy. | Disitamab Vedotin (RC48) A HER2-targeted antibody-drug conjugate comprising a humanized anti-HER2 monoclonal antibody linked via a cathepsin-cleavable MC-VC-PAB linker to the microtubule inhibitor MMAE (drug-to-antibody ratio ≈4). Administered intravenously at 2.0 mg/kg every 2 weeks. Pyrotinib An irreversible pan-HER tyrosine kinase inhibitor targeting HER1, HER2, and HER4, inhibiting downstream PI3K/Akt and MAPK signaling. Administered orally at 320 mg once daily (post-meal) in combination with RC48. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Objective Response Rate (ORR) | The Objective Response Rate (ORR) is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria, as assessed by independent radiological review. Tumor assessments will be performed every 6 weeks. This endpoint evaluates the antitumor activity of RC48 in combination with either bevacizumab or pyrotinib in patients with HER2-positive advanced breast cancer who have failed prior treatment with trastuzumab deruxtecan (T-Dxd). | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Progression-Free Survival (PFS) | Progression-Free Survival is defined as the time from the date of randomization to the date of first documented disease progression (per RECIST v1.1 by independent review) or death from any cause, whichever occurs first. PFS will be used to evaluate the efficacy of the combination regimens in delaying disease progression in patients with HER2-positive advanced breast cancer previously treated with trastuzumab deruxtecan. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
Overall Survival (OS) | Overall Survival is defined as the time from randomization to death from any cause. Patients who are still alive at the time of analysis will be censored at the date of last follow-up. OS will provide a measure of the survival benefit of RC48 combined with either bevacizumab or pyrotinib. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
Duration of Response (DoR) | Duration of Response is defined as the time from the first documentation of objective tumor response (CR or PR per RECIST v1.1) to the time of disease progression or death. Only patients with confirmed objective response will be included in this analysis. | From first documented response until disease progression or death, assessed up to 24 months |
Disease Control Rate (DCR) | Disease Control Rate is defined as the proportion of patients who achieve a complete response (CR), partial response (PR), or stable disease (SD) lasting at least 6 weeks, based on RECIST v1.1 as assessed by independent review. | Assessed at 6 weeks and every 8 weeks thereafter up to 24 months |
Incidence of Treatment-Related Adverse Events | The incidence and severity of treatment-related adverse events (TRAEs) will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. This measure aims to evaluate the safety and tolerability of the treatment regimens. | From first dose until 30 days after last dose, assessed up to 36 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- Age ≥18 years.
- Histologically or cytologically confirmed HER2-positive (IHC 3+ or IHC 2+ with ISH amplification) advanced or metastatic breast cancer.
- Prior treatment with trastuzumab deruxtecan (T-DXd) and documented disease progression during or after therapy.
- At least one measurable lesion at baseline as defined by RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and marrow function, including:
Absolute neutrophil count ≥1.5 × 10⁹/L Platelet count ≥100 × 10⁹/L Hemoglobin ≥9 g/dL ALT and AST ≤2.5 × ULN Total bilirubin ≤1.5 × ULN Creatinine clearance ≥50 mL/min Estimated life expectancy of ≥12 weeks. Ability to understand and willingness to sign a written informed consent form.
- Prior treatment with disitamab vedotin (RC48).
- Active infections requiring systemic therapy (bacterial, viral, or fungal).
- History of interstitial lung disease or non-infectious pneumonitis requiring corticosteroid therapy.
- Uncontrolled cardiovascular disease, including but not limited to: uncontrolled hypertension, recent myocardial infarction (within 6 months), unstable angina, or congestive heart failure.
- Pregnant or breastfeeding women.
- Concurrent malignancy other than adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix, unless disease-free for ≥5 years.
- Participation in another interventional clinical trial with investigational agents not yet completed.
- Any condition that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements or jeopardize their safety.
The First Affiliated Hospital with Nanjing Medical University- 🏥RenJi Hospital
Study Central Contact
Contact: Wei Li, Ph.D, 025-68307102, [email protected]
1 Study Locations in 1 Countries
Jiangsu
The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China
Wei Li, Ph.D, Contact, 025-68307102, [email protected]
Recruiting