SKB264 Combined With KL-A167 Neoadjuvant Therapy for Early-stage, High-risk ER+/HER2- Breast Cancer
NCT07109284 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2025-08-07
Summary
This study aimed to evaluate the efficacy and safety of SKB264 combined with KL-A167 as neoadjuvant therapy in early-stage high-risk ER+HER2- breast cancer patients.
Conditions
- ER+HER2- Breast Cancer
Interventions
- BIOLOGICAL
-
Sacituzumab tirumotecan 5 mg/kg, intravenously (iv), Q2W
- BIOLOGICAL
-
Tagitanlimab
Tagitanlimab 900mg, intravenously (iv), Q2W
Sponsors & Collaborators
-
West China Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-30
- Primary Completion
- 2028-01-31
- Completion
- 2030-12-31
More Related Trials
-
SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer
NCT05445908 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Sacituzumab Tirumotecan Plus Tagitanlimab in Previously Treated Locally Advanced or Metastatic Triple Negative Breast Cancer
NCT07153965 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
NCT06279364 ·Status: RECRUITING ·Phase: PHASE3
-
Combined Chemo-immunotherapy Plus SBRT in Neoadjuvant Treatment for Luminal Subtype Breast Cancer
NCT07254858 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
NCT06393374 ·Status: RECRUITING ·Phase: PHASE3
-
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
NCT05382286 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC
NCT06927180 ·Status: RECRUITING ·Phase: PHASE2
-
Real-world Study of Sacituzumab Govitecan Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer
NCT07018427 ·Status: ACTIVE_NOT_RECRUITING
-
SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer
NCT05347134 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer
NCT03907800 ·Status: UNKNOWN ·Phase: PHASE2
-
NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer
NCT07178730 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)
NCT06841354 ·Status: RECRUITING ·Phase: PHASE3
-
Nab-P+Cb+PD1 Inhibitors as Neoadjuvant Therapy for Early TNBC
NCT06817525 ·Status: RECRUITING ·Phase: PHASE2
-
A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer
NCT06747338 ·Status: RECRUITING ·Phase: PHASE3
-
Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer
NCT04138719 ·Status: RECRUITING ·Phase: PHASE2
-
Adjuvant Therapy for Intermediate Risk HER2 Positive, Lymph Node Negative Early Breast Cancer With Chemotherapy Combined Target Therapy
NCT06711068 ·Status: RECRUITING
-
Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer
NCT05429684 ·Status: UNKNOWN ·Phase: PHASE3
-
Neoadjuvant Adebrelimab and Chemotherapy in High-rish ER+/HER2- BC
NCT06500208 ·Status: RECRUITING ·Phase: PHASE2
-
Marched Pair Study Conventional Doxorubicin(DOX) Versus Pegylated Liposomal Doxorubicin(PLD) Neoadjuvant Chemotherapy
NCT02953184 ·Status: UNKNOWN ·Phase: PHASE2
-
Nab-paclitaxel Based Regimens VS Paclitaxel Based Regimens in Neoadjuvant Treatment for TNBC
NCT04067102 ·Status: WITHDRAWN ·Phase: NA
-
SHR-1210 Combined With Albumin-bound Paclitaxel and Epirubicin Neoadjuvant for Triple Negative Breast Cancer
NCT04213898 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
NCT06312176 ·Status: RECRUITING ·Phase: PHASE3
-
NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)
NCT06081244 ·Status: RECRUITING ·Phase: PHASE3
-
QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk ER+/HER2- Breast Cancer
NCT06404463 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Phase II Study Evaluating the Efficacy and Safety of Pembrolizumab in Combination With Chemotherapy as Neoadjuvant Therapy for Triple-negative Breast Cancer
NCT05681728 ·Status: UNKNOWN ·Phase: PHASE2