Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer
NCT06105008 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2024-08-23
Summary
This study will evaluate the efficacy, safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC in endocrine-resistant hormone receptor (HR) positive, human epidermal growth factor receptor (HER)2-low advanced breast cancer.
Conditions
- Breast Neoplasms
Interventions
- DRUG
-
Disitamab Vedotin
2.0 mg/kg intravenous (lV) infusion every 2 weeks
- DRUG
-
Toripalimab
3.0 mg/kg intravenous (lV) infusion every 2 weeks
Sponsors & Collaborators
-
RemeGen Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jianmin Fang, Ph.D · RemeGen Co., Ltd.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-20
- Primary Completion
- 2025-12-20
- Completion
- 2026-04-10
Countries
- China
Study Locations
More Related Trials
-
Disitamab Vedotin in Combination with Metronomic Chemotherapy in Advanced HER2-expressing Breast Cancer.
NCT06857747 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
RO4929097 and Vismodegib in Treating Patients With Breast Cancer That is Metastatic or Cannot Be Removed By Surgery
NCT01071564 ·Status: TERMINATED ·Phase: PHASE1
-
Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer : a Randomized, Open-label, Parallel-controlled, Multi-center Phase III Study (NEOTORCH-BREAST04)
NCT06977893 ·Status: RECRUITING ·Phase: PHASE3
-
XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer
NCT00386685 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Study of Niraparib in Metastatic TNBC Patients With Homologous Recombination Deficiency
NCT05461690 ·Status: UNKNOWN ·Phase: PHASE2
-
Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted
NCT04185311 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of Herceptin (Trastuzumab) in Combination With Xeloda (Capecitabine) in Patients With Metastatic or Recurrent HER2-positive Breast Cancer After First-Line or (Neo)Adjuvant Therapy.
NCT01290718 ·Status: TERMINATED ·Phase: PHASE2
-
A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
NCT05104866 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOTORCH-BREAST01)
NCT06611813 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Etoposide in Treating Patients With Recurrent or Metastatic Breast Cancer
NCT01492556 ·Status: UNKNOWN ·Phase: PHASE2
-
Tucatinib in Combination With Oral Etoposide andTrastuzumab in Patients With Metastatic HER2+ Breast Cancer
NCT05955170 ·Status: RECRUITING ·Phase: PHASE2
-
Neoadjuvant Chemotherapy Combined With Toripalimab for TNBC (NEOTORCH-BREAST02)
NCT06682195 ·Status: RECRUITING ·Phase: PHASE2
-
Phase 2 Study of Trastuzumab and Etoposide for Her2 Positive Breast Cancer
NCT00810017 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Assess the Safety, Tolerability and Antitumor Activity of X4P-001 in Combination With TNBC
NCT05103917 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers
NCT05232006 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy
NCT06968585 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer
NCT06519370 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease
NCT04915755 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2
NCT04400695 ·Status: RECRUITING ·Phase: PHASE3
-
Efficacy and Safety of Disitamab Vedotin Plus Pyrotinib or Naratinib in HER2-positive Breast Cancer Patients With Brain Metastasis
NCT06015113 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Investigator-Selected Chemotherapy in HER2 Low-Expressing Recurrent/Metastatic Breast Cancer
NCT06561607 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer
NCT00387907 ·Status: COMPLETED ·Phase: PHASE2
-
Phase Ib/II Trials of RAD001 in Triple Negative Metastatic Breast Cancer
NCT01939418 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Intravenous RPR109881 in Male or Female Patients With Advanced Breast Cancer Who no Longer Respond to Anthracycline, Taxane and Capecitabine Treatment
NCT00087958 ·Status: COMPLETED ·Phase: PHASE2
-
Lapatinib With Trastuzumab in Treating Patients With HER2-Negative/HER2 Mutant Metastatic Breast Cancer
NCT01557764 ·Status: WITHDRAWN ·Phase: PHASE2