Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

July 27, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Breast Cancer
Interventions
DRUG

Disitamab Vedotin Injection (18 weeks)

2.0mg/kg, intravenous infusion,D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 3 cycles (18 weeks) of treatment are performed.

DRUG

Toripalimab (18weeks)

3.0 mg/kg, intravenous infusion, D1, every 2 weeks

DRUG

Carboplatin

AUC 3 Q2W or AUC1.5 QW intravenous infusion

DRUG

Disitamab Vedotin Injection (12 weeks)

2.0mg/kg, intravenous infusion,D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed.

DRUG

Sequential Epirubicin

According to body surface area, 90mg/m2, intravenous infusion, D1, every 3 weeks, A total of 12 weeks of treatment are performed.

DRUG

Sequential CTX

According to body surface area,600mg/m2, intravenous infusion, D1, every 3 weeks, A total of 12 weeks of treatment are performed.

DRUG

Toripalimab (12weeks)

3.0 mg/kg, intravenous infusion, D1, every 2 weeks, A total of 2 cycles (12 weeks) of treatment are performed. Sequential therapy 3.0 mg/kg, intravenous infusion, D1, every 2 weeks, A total of 2 cycles (12 weeks) of treatment are performed.

Trial Locations (5)

300060

NOT_YET_RECRUITING

Tianjin Medical University Cancer Institute & Hospital, Tianjin

310005

NOT_YET_RECRUITING

Zhejiang Cancer Hospital, Hangzhou

410008

NOT_YET_RECRUITING

Xiangya Hospital Central South University, Changsha

410031

NOT_YET_RECRUITING

Hunan Cancer Hospital, Changsha

Unknown

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

RemeGen Co., Ltd.

INDUSTRY