Targeted drug TQB2102 takes aim at HER2-Low breast cancer

NCT ID NCT06561607

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are testing an experimental antibody-drug conjugate called TQB2102 in people with recurrent or metastatic breast cancer that has low levels of the HER2 protein. The trial enrolls about 542 adults who have not yet received chemotherapy for their advanced disease. Participants are randomly assigned to receive either TQB2102 or one of three standard chemotherapy drugs chosen by their doctor. The main goal is to see whether TQB2102 delays cancer progression longer than chemotherapy, and to compare side effects between the two approaches.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: TQB2102, an experimental antibody-drug conjugate that targets HER2
What this could lead to: If it works, TQB2102 could offer people with HER2-low metastatic breast cancer a targeted option that delays cancer growth better than standard single-drug chemotherapy.
What could go wrong: The trial is still testing an experimental drug, so TQB2102 may not outperform chemotherapy or may cause side effects that limit its use. Results in this specific group may not apply to other breast cancer types.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 542 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * The presence or current concurrent presence of other malignant tumors within 5 years prior to randomization. ; * Unresolved toxic reactions above Common Terminology Criteria (CTC) for Adverse Events (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; * Those with a history of psychotropic substance abuse that cannot be abstained from or those with psychiatric disorders; * Tumor-related symptoms and treatments: 1. Subjects who have been treated with other antineoplastic agents such as chemotherapy, radical radiotherapy, or immunotherapy within 4 weeks prior to randomization, or who are still within 5 half-lives of the drug (whichever occurs shortest); 2. Treatment with endocrine therapy, molecularly targeted therapy, or a proprietary Chinese medicine with an anti-tumor indication as specified in the National Medical Products Administration (NMPA) approved drug insert within 2 weeks prior to randomization; 3. Presence of carcinomatous lymphadenitis, or uncontrollable pleural effusion, ascites, and pericardial effusion of moderate volume or greater that requires repeated drainage to relieve clinical symptoms, or who have received drainage of plasmapheresis for therapeutic purposes within 2 weeks prior to randomization; 4. Known carcinomatous meningitis or clinically active central nervous system metastases; 5. Severe bone damage resulting from tumor bone metastases; * Those who have received a control chemotherapeutic agent of the investigator's choice during the recurrent metastatic phase or for whom a control chemotherapeutic agent of the investigator's choice is inappropriate for reasons such as intolerance or contraindication to that agent; * Has received prior anti-HER2 therapy; * Who have developed hypersensitivity to humanized monoclonal antibody products; * Those who have developed an allergy to any of the study drugs or any component or excipient in the drugs; * Who have participated in and used another antitumor clinical trial drug within 4 weeks prior to randomization; * Subjects who, in the judgment of the investigator, have a concomitant disease that seriously jeopardizes the safety of the subject or interferes with the completion of the study, or who are deemed to have other reasons for being unsuitable for enrollment.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China
Affiliated Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310004, China
Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524001, China
Affiliated Hospital of Hebei University

Baoding, Hebei, China
Affiliated Hospital of North Scichuan Medical College

Nanchong, Sichuan, 637000, China
AnHui Province Hospital West District

Hefei, Anhui, 230000, China
AnYang Tumor Hospital

Anyang, Henan, 455100, China
Baoji Central Hospital

Baoji, Shanxi, 721008, China
Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China
Binzhou Medical College Affiliated Hospital

Binzhou, Shandong, 256699, China
Binzhou People's Hospital

Binzhou, Shandong, 310053, China
Cancer Hospital Affiliated to Guangxi Medical University

Nanning, Guangxi, 530021, China
Chengde Central Hospital

Chengde, Hebei, 067024, China
Chifeng Municipal Hospital

Chifeng, Inner Mongolia, 24099, China
Fujian Medical University 2nd Affiliated Hospital

Quanzhou, Fujian, 362000, China
Gansu Provincial Cancer Hospital

Lanzhou, Gansu, 730050, China
Gansu Provincial Hospital

Lanzhou, Gansu, 730000, China
Gansu Wuwei Tumour Hospital

Wuwei, Gansu, 730000, China
Guigang City People'S Hospital

Guigang, Guangxi, 537100, China
Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550002, China
Hainan General Hospital

Haikou, Hainan, 570311, China
Henan Cancar Hospital

Zhengzhou, Henan, 450000, China
Hubei Cancer Hospital

Wuhan, Hubei, 430079, China
Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200082, China
Sun Yet-Sen University Cancer Certer

Guangzhou, Guangdong, 510000, China
The Affiliated Cancer Hospital of Guizhou Medical University Co., LTD

Guiyang, Guizhou, 550000, China
The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233004, China
The First Affiliated Hospital of Hainan Medical College

Haikou, Hainan, 570102, China
The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Hennan, 471003, China
The First affiliated hospital of GuangXi medical university

Nanning, Guangxi, 530021, China
The Second Hospital of DALIAN Medical University

Dalian, Liaoning, 116000, China
The first Affiliated hospital of anhui medical university

Hefei, Anhui, 230000, China
Tongji Hospital Tongji Medical College of HUST

Wuhan, Hubei, 430034, China
Zhangzhou Hospital in Fujian Province

Zhangzhou, Fujian, 363000, China

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