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 | Not Yet Recruiting Phase 3

• 1 other identifier: TQB2102-III-01
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 34

Brief Summary

The study is a Phase III, randomized, multicenter, open-label study in HER2-low, HR+ metastatic breast cancer subjects who are patients with locally advanced or metastatic breast cancer with low HER2 expression in the recurrent metastatic stage who have not received chemotherapy. The primary objective of the study is to determine the efficacy and safety of TQB2102 compared to investigator-selected single-agent chemotherapy in the target population. 542 subjects with HER2 immunohistochemistry (IHC )2+/ in situ hybridization (ISH)- and IHC 1+ (HER2-low) expression will be enrolled in 1:1 randomized groups to receive TQB2102 or investigator's choice of single-agent chemotherapy (capecitabine, paclitaxel, or albumin-paclitaxel) until progression of disease (PD), as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1. 1, unless there are unacceptable toxicity, withdrawal of consent, or meeting other discontinuation criteria.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer as assessed by Independent Review Committee (IRC)

  Designed to demonstrate that in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer, TQB2102 for injection significantly prolongs progression-free survival in subjects compared to investigator-selected chemotherapy.

  Up to 25 months

Secondary Outcomes (14)

• Progression-free survival (PFS) in subjects with HER2 low-expressing recurrent/metastatic breast cancer as assessed by IRC

  Up to 25 months

• Progression-free survival (PFS) as assessed by investigators in the HR-positive, HER2 low-expressing population

  Up to 25 months

• Investigator-assessed overall survival (OS) in HR-positive, low HER2-expressing population.

  Up to 25 months

• Overall survival (OS) as assessed by investigators in the HR-positive, HER2 low-expressing population

  Up to 25 months

• Duration of remission (DOR) as assessed by investigators in the HR-positive, HER2 low-expressing population

  Up to 25 months

Study Arms (2)

TQB2102 for Injection

EXPERIMENTAL

Administered by intravenous drip, 7.5 mg/kg per dose, 21 days as a treatment cycle.

Drug: TQB2102 for Injection

Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)

ACTIVE COMPARATOR

Based on each patient's condition and previous treatment history, the investigator will select one of the following chemotherapy drugs for treatment. * Capecitabine * Paclitaxel * Albumin Paclitaxel

Drug: Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)

Interventions

TQB2102 for Injection DRUG

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

TQB2102 for Injection

Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel) DRUG

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.

Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntarily enrolled in this study with good compliance;
• Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1;
• Pathologically confirmed locally advanced or metastatic breast cancer with low HER2 expression and unresectable:
• Defined hormone receptor (HR) status.
• Imaging-confirmed disease progression (during or after completion of the most recent treatment);
• Have at least one measurable lesion according to RECIST 1.1 criteria;
• Good major organ function.

You may not qualify if:

• The presence or current concurrent presence of other malignant tumors within 5 years prior to randomization. ;
• Unresolved toxic reactions above Common Terminology Criteria for Adverse Events (CTC AE) grade 1 due to any prior therapy;
• Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of the pre-randomization period;
• Prolonged unhealed wounds or fractures;
• Previous history of interstitial lung disease/pneumonia requiring steroidal drug intervention;
• The presence of moderate to severe pulmonary dysfunction/disease within 3 months prior to randomization;
• The presence of an arterial/deep vein thrombotic event within 6 months prior to randomization;
• The presence of a medical condition that interferes with intravenous administration, intravenous blood collection, or inability to swallow, chronic diarrhea, intestinal obstruction, or the presence of other factors that interfere with the administration and absorption of medications;
• The presence of grade ≥2 myocardial ischemia or myocardial infarction, cardiac arrhythmias (including QT corrected (QTc) ≥450ms (men) and QTc ≥470ms (women)) and grade ≥2 congestive heart failure (New York Heart Association (NYHA) classification); angina pectoris requiring antianginal medication; and clinically significant heart valve disease;
• Active or uncontrolled ≥ CTC AE grade 2 infection present within 14 days prior to randomization;
• Cirrhosis of the liver, active hepatitis that is not well controlled;
• Renal failure requiring hemodialysis or peritoneal dialysis;
• History of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
• Those with routine urinalysis suggestive of urinary protein ≥++ and confirmed 24-hour urine protein quantification \>1.0 g;
• Those who have used immunosuppressive or systemic hormone therapy for immunosuppression within 2 weeks prior to randomization;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (34)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233004, China

Location

AnHui Province Hospital West District

Hefei, Anhui, 230000, China

Location

The first Affiliated hospital of anhui medical university

Hefei, Anhui, 230000, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Fujian Medical University 2nd Affiliated Hospital

Quanzhou, Fujian, 362000, China

Location

Zhangzhou Hospital in Fujian Province

Zhangzhou, Fujian, 363000, China

Location

Gansu Provincial Hospital

Lanzhou, Gansu, 730000, China

Location

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, 730050, China

Location

Gansu Wuwei Tumour Hospital

Wuwei, Gansu, 730000, China

Location

Sun Yet-Sen University Cancer Certer

Guangzhou, Guangdong, 510000, China

Location

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524001, China

Location

Guigang City People'S Hospital

Guigang, Guangxi, 537100, China

Location

Cancer Hospital Affiliated to Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

The First affiliated hospital of GuangXi medical university

Nanning, Guangxi, 530021, China

Location

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

Guiyang, Guizhou, 550000, China

Location

Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550002, China

Location

The First Affiliated Hospital of Hainan Medical College

Haikou, Hainan, 570102, China

Location

Hainan General Hospital

Haikou, Hainan, 570311, China

Location

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Location

Chengde Central Hospital

Chengde, Hebei, 067024, China

Location

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

Location

AnYang Tumor Hospital

Anyang, Henan, 455100, China

Location

Henan Cancar Hospital

Zhengzhou, Henan, 450000, China

Location

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Hennan, 471003, China

Location

Tongji Hospital Tongji Medical College of HUST

Wuhan, Hubei, 430034, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Chifeng Municipal Hospital

Chifeng, Inner Mongolia, 24099, China

Location

The Second Hospital of DALIAN Medical University

Dalian, Liaoning, 116000, China

Location

Binzhou Medical College Affiliated Hospital

Binzhou, Shandong, 256699, China

Location

Binzhou People's Hospital

Binzhou, Shandong, 310053, China

Location

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200082, China

Location

Baoji Central Hospital

Baoji, Shanxi, 721008, China

Location

Affiliated Hospital of North Scichuan Medical College

Nanchong, Sichuan, 637000, China

Location

Affiliated Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310004, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Injections; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Qingyuan Zhang, Doctor

CONTACT

13313612989; ns86298333@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 20, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 20, 2024

Record last verified: 2024-07

Locations

CN (34)