NCT05726175

Disitamab Vedotin(RC48) Combined With Penpulimab(AK105) for Neoadjuvant Treatment of HER2-low Breast Cancer

A Single-arm, Single-center Exploratory Clinical Study of Disitamab Vedotin Combined With Penpulimab as Neoadjuvant Therapy in the Treatment of HER2-low Early or Locally Advanced Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of Disitamab Vedotin combined with Penpulimab as neoadjuvant therapy in patients with HER2-low early or locally advanced breast cancer

Detailed description

Subjects who met the criteria for admission were treated with Disitamab Vedotin（2.0mg/kg,iv,q3w） combined with Penpulimab (200mg,iv,q3w) as neoadjuvant therapy for 6 cycles before surgery, and DCR and ORR were assessed before surgery. All subjects who are suitable for surgery undergo surgery and evaluate their pCR rate (pathological complete remission rate). The postoperative treatment plan was developed according to the subjects' condition and willingness。

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin	Disitamab Vedotin(RC48)：2.0mg/kg, iv, day1, q3weeks, 6 cycles in total;
DRUG	Penpulimab	Penpulimab(AK105)：200mg, iv, day1, q3weeks, 6 cycles in total;

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-07-31
• Completion: 2024-08-31
• First posted: 2023-02-13
• Last updated: 2023-02-13

Locations

1 site across 1 country: China