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A randomized, open, Parallel-Controlled phase III clinical trial evaluating the efficacy and safety of TQB2102 for injection versus Investigator-Selected chemotherapy in HER2 Low-Expressing Recurrent/Metastatic breast cancer

NCT ID NCT06561607

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

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

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.

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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 Neoplasms

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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