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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

542

Participants

Timeline

Start Date

August 31, 2024

Primary Completion Date

January 31, 2027

Study Completion Date

December 31, 2028

Conditions
Breast Cancer
Interventions
DRUG

TQB2102 for Injection

TQB2102 is a next-generation HER2 Antibody-Drug Conjugate (ADC) drug proposed for patients with HER2 low-expressing breast cancer.

DRUG

Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)

"Based on each patient's condition and previous treatment history, the investigator will select one of the chemotherapy drugs for treatment.~* Capecitabine: 1000-1250 mg/m2 twice daily, administered consecutively on day 1-14, 21 days as a treatment cycle.~* Paclitaxel: 175 mg/m2, IV infusion, administered Day1 per cycle, 21 days as a treatment cycle. OR 80 mg/m2 by IV infusion administered weekly.~* Albumin Paclitaxel: 260 mg/m2, IV infusion, administered every cycle of Day1 for 21 days as a treatment cycle. 100 mg/m2 or 125 mg/m2, IV infusion, administered every cycle of Day 1 and Day 8 for 21 days as a treatment cycle; or Day 1, Day 8, and Day 15 administered every cycle for 28 days as a treatment cycle."

Trial Locations (34)

24099

Chifeng Municipal Hospital, Chifeng

100142

Beijing Cancer Hospital, Beijing

116000

The Second Hospital of DALIAN Medical University, Dalian

150081

Affiliated Cancer Hospital of Harbin Medical University, Harbin

200082

Obstetrics & Gynecology Hospital of Fudan University, Shanghai

230000

AnHui Province Hospital West District, Hefei

The first Affiliated hospital of anhui medical university, Hefei

233004

The First Affiliated Hospital of Bengbu Medical University, Bengbu

256699

Binzhou Medical College Affiliated Hospital, Binzhou

310004

Affiliated Hangzhou First People's Hospital, Hangzhou

310053

Binzhou People's Hospital, Binzhou

362000

Fujian Medical University 2nd Affiliated Hospital, Quanzhou

363000

Zhangzhou Hospital in Fujian Province, Zhangzhou

430034

Tongji Hospital Tongji Medical College of HUST, Wuhan

430079

Hubei Cancer Hospital, Wuhan

450000

Henan Cancar Hospital, Zhengzhou

455100

AnYang Tumor Hospital, Anyang

471003

The First Affiliated Hospital of Henan University of Science & Technology, Luoyang

510000

Sun Yet-Sen University Cancer Certer, Guangzhou

524001

Affiliated Hospital of Guangdong Medical University, Zhanjiang

530021

Cancer Hospital Affiliated to Guangxi Medical University, Nanning

The First affiliated hospital of GuangXi medical university, Nanning

537100

Guigang City People'S Hospital, Guigang

550000

The Affiliated Cancer Hospital of Guizhou Medical University Co., LTD, Guiyang

550002

Guizhou Provincial People's Hospital, Guiyang

570102

The First Affiliated Hospital of Hainan Medical College, Haikou

570311

Hainan General Hospital, Haikou

637000

Affiliated Hospital of North Scichuan Medical College, Nanchong

721008

Baoji Central Hospital, Baoji

730000

Gansu Provincial Hospital, Lanzhou

Gansu Wuwei Tumour Hospital, Wuwei

730050

Gansu Provincial Cancer Hospital, Lanzhou

Unknown

Affiliated Hospital of Hebei University, Baoding

067024

Chengde Central Hospital, Chengde

All Listed Sponsors
lead

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY