New HER2 drug aims to shrink tumors before breast cancer surgery

NCT ID NCT07043725

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

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 3 trial compares a new drug called TQB2102 against a standard chemotherapy combination (TCbHP) for people with HER2-positive breast cancer. The goal is to see if TQB2102 works better at eliminating cancer before surgery. About 544 participants will be randomly assigned to one of the two treatments. The study is currently recruiting.

What this could mean

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

Active substance: TQB2102 (a HER2-targeting antibody-drug conjugate)
What this could lead to: If successful, TQB2102 could offer a more targeted, potentially less toxic neoadjuvant option for HER2-positive breast cancer, improving complete response rates before surgery.
What could go wrong: This is an early Phase 3 trial; results may not confirm superiority over existing therapy. Side effects from the new drug are still being evaluated, and long-term outcomes like survival are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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 544 people

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

Started

Sep 2025

Expected to finish

Sep 2029

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: * Voluntarily participate in this study, sign the informed consent form, and have good compliance; * Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; expected survival \>6 months; * Histologically or cytologically confirmed HER2-positive invasive breast cancer; * Hormone receptor (HR) status confirmed; * Clinical stage at diagnosis: T2-4 with any N, M0, or any T with N1-3, M0; * Agree to undergo breast cancer resection if meeting surgical criteria after neoadjuvant therapy; * Major organ function is adequate, meeting specific criteria; * Must agree to use contraception during the study and for 6 months after study completion; female patients must have a negative serum pregnancy test within 7 days before enrollment and must not be lactating; male subjects must agree to use contraception during the study and for 6 months after study completion Exclusion Criteria: * Stage IV metastatic breast cancer or other cases judged by the investigator as unsuitable for radical surgical resection after neoadjuvant therapy; * Bilateral breast cancer or inflammatory breast cancer; * History of invasive breast cancer or ductal carcinoma in situ; * Prior anti-tumor therapy for breast cancer, including chemotherapy, endocrine therapy, targeted therapy, radiotherapy, surgery, etc.; * Comorbidities and medical history: * Other malignancies within 5 years or currently; * Adverse reactions from prior treatment not recovered to CTCAE v5.0 grade ≤1; * Major surgery, significant traumatic injury within 4 weeks before first dose, or anticipated major surgery during the study, or unhealed wounds/fractures; * Conditions affecting intravenous injection or blood sampling; * Congenital bleeding or coagulation disorders, or bleeding/coagulation disorders within 28 days before study treatment, or use of aspirin \>325 mg/day (maximum antiplatelet dose), dipyridamole, ticlopidine, clopidogrel, or cilostazol within 7 days before study treatment; * Arterial/deep venous thrombotic events within 6 months before first dose, e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism; * Poorly controlled blood pressure (systolic ≥150 mmHg or diastolic ≥100 mmHg); * Significant cardiovascular disease, including； * Uncontrolled ≥CTCAE grade 2 infection within 14 days before study treatment; * History of interstitial lung disease/pneumonitis (non-infectious) requiring steroid treatment, current interstitial lung disease/pneumonitis, or suspected interstitial lung disease/pneumonitis on screening imaging that cannot be ruled out; * Tumor-related symptoms and treatment: * Prior excisional biopsy of primary tumor and/or axillary lymph nodes or sentinel lymph node biopsy before study treatment; * Surgery, chemotherapy, radiotherapy, or other anti-tumor therapy within 3 weeks before study treatment (washout period calculated from last treatment); * Prior taxane or carboplatin therapy for any malignancy; * Treatment with National Medical Products Administration-approved traditional Chinese medicine with clear anti-tumor indications within 2 weeks before study treatment. * Study treatment-related: * Severe hypersensitivity to monoclonal antibodies; * Uncontrolled active autoimmune disease within 2 weeks before study treatment; * Allergy to any study drug or its components/excipients; * Live vaccination within 28 days before study treatment, including measles, mumps, rubella, varicella, yellow fever, seasonal flu, Influenza A virus subtype (H1N1) flu, rabies, Bacille Calmette-Guerin vaccine (BCG), and typhoid vaccines. * Any condition judged by the investigator to jeopardize subject safety or study completion.

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Conditions

The condition(s) this trial relates to.

HER2 positive breast carcinoma

As listed by the trial registrant

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

HER2-positive breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

78 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Anhui Provincial Cancer Hospital
NOT_YET_RECRUITING

Hefei, Anhui, 230000, China
Anyang Tumor Hospital
NOT_YET_RECRUITING

Anyang, Henan, 455001, China
Beijing Cancer Hospital
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100142, China
Cancer Hospital of Shandong First Medical University, Shandong Cancer Institute, Shandong Cancer Hospital
RECRUITING

Jinan, Shandong, 250117, China
Cangzhou Central Hospital
NOT_YET_RECRUITING

Cangzhou, Hebei, 061012, China
Chifeng Municipal Hospital
NOT_YET_RECRUITING

Chifeng, Inner Mongolia, 24000, China
First Hospital of QinHuangDao
NOT_YET_RECRUITING

Qinhuangdao, Hebei, 066099, China
First Hospital of Shanxi Medical University
NOT_YET_RECRUITING

Taiyuan, Shanxi, 030001, China
Fudan University Shanghai Cancer Center
RECRUITING

Shanghai, Shanghai Municipality, 200030, China
Gansu Provincial Academic Institute for Medical Research, Gansu Provincial Cancer Hospital
NOT_YET_RECRUITING

Lanzhou, Gansu, 730050, China
Gansu Wuwei Tumour Hospital
NOT_YET_RECRUITING

Wuwei, Gansu, 730000, China
Guangxi Cancer Institutu (Guangxi Cancer Hospital, Guangxi Medical University Cancer Hospital, Guangxi Cancer Center)
NOT_YET_RECRUITING

Nanning, Guangxi, 530021, China
Guigang City People's Hospital
NOT_YET_RECRUITING

Guigang, Guangxi, 537300, China
Guizhou Provincial People's Hospital
NOT_YET_RECRUITING

Guiyang, Guizhou, 550002, China
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING

Harbin, Heilongjinag, 150081, China
Huashan Hospital Fudan University
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200052, China
Jiamusi Cancer Hospital
RECRUITING

Jiamusi, Heilongjiang, 154002, China
Jiangsu Province Hospital
NOT_YET_RECRUITING

Nanjing, Jiangsu, 210029, China
Jiangxi Cancer Hospital
NOT_YET_RECRUITING

Nanchang, Jiangxi, 330029, China
Liaoning Cancer Hospital & Institute
NOT_YET_RECRUITING

Shenyang, Liaoning, 111000, China
Linyi Cancer Hospital
NOT_YET_RECRUITING

Linyi, Shandong, 276034, China
Meizhou People's Hospital
NOT_YET_RECRUITING

Meizhou, Guangdong, 514000, China
NanChang People's Hospital
NOT_YET_RECRUITING

Nanchang, Jiangxi, 330009, China
Nanjing Drum Tower Hospital
NOT_YET_RECRUITING

Nanjing, Jiangsu, 210031, China
Ningbo Medical Center Lihuili Hospital
NOT_YET_RECRUITING

Ningbo, Zhejiang, 315000, China
Peking Union Medical College Hospital
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100005, China
Quanzhou First Hospital
NOT_YET_RECRUITING

Quanzhou, Fujian, 362000, China
Shantou Central Hospital
NOT_YET_RECRUITING

Shantou, Guangdong, 515031, China
Shanxi Cancer Hospital
NOT_YET_RECRUITING

Taiyuan, Shanxi, 030000, China
Shaoxing People's Hospital
NOT_YET_RECRUITING

Shaoxing, Zhejiang, 212300, China
Shengjing Hospital Of China Medical University
NOT_YET_RECRUITING

Shenyang, Liaoning, 110000, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
NOT_YET_RECRUITING

Chengdu, Sichuan, 610031, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510000, China
Taizhou Hospital of Zhejiang Province
NOT_YET_RECRUITING

Taizhou, Zhejiang, 317000, China
The Affiliated Cancer Hospital of Guizhou Medical University
NOT_YET_RECRUITING

Guiyang, Guizhou, 550001, China
The Affiliated Hospital of Southwest Medical University
NOT_YET_RECRUITING

Luzhou, Sichuan, 646000, China
The Cancer Hospital Affiliated to Chongqing University, Chongqing Cancer Hospital, Chongqing Cancer Research Institute, and Chongqing Cancer Center
NOT_YET_RECRUITING

Chongqing, Chongqing Municipality, 400030, China
The First Affiliated Hospital of Bengbu Medical University
NOT_YET_RECRUITING

Bengbu, Anhui, 233000, China
The First Affiliated Hospital of China Medical University
NOT_YET_RECRUITING

Shenyang, Liaoning, 110002, China
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING

Chongqing, Chongqing Municipality, 400010, China
The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING

Nanning, Guangxi, 530022, China
The First Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITING

Luoyang, Henan, 471000, China
The First Affiliated Hospital of Jinzhou Medical University
NOT_YET_RECRUITING

Jinzhou, Liaoning, 121012, China
The First Affiliated Hospital of Ningbo University
NOT_YET_RECRUITING

Ningbo, Zhejiang, 315000, China
The First Affiliated Hospital of University of South China
NOT_YET_RECRUITING

Hengyang, Hunan, 421200, China
The First Affiliated Hospital of Wannan Medical University
NOT_YET_RECRUITING

Wuhu, Anhui, 241000, China
The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING

Wenzhou, Zhejiang, 325000, China
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING

Xi'an, Shaanxi, 710061, China
The First Affiliated Hospital of Xinxiang Medical University
NOT_YET_RECRUITING

Xinxiang, Henan, 453100, China
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING

Zhengzhou, Henan, 453000, China
The First Affiliated Hospital of the Air Force Medical University of the People's Liberation Army
NOT_YET_RECRUITING

Xi'an, Shaanxi, 710005, China
The First Bethune Hospital of Jilin University
NOT_YET_RECRUITING

Changchun, Jilin, 130000, China
The First Hospital Affiliated to Army Medical University
NOT_YET_RECRUITING

Chongqing, Chongqing Municipality, 400038, China
The First Hospital of Lanzhou University
NOT_YET_RECRUITING

Lanzhou, Gansu, 730000, China
The Fourth Hospital of Hebei Medical University
NOT_YET_RECRUITING

Shijiazhuang, Hebei, 050035, China
The People's Hospital of Anyang City
NOT_YET_RECRUITING

Anyang, Henan, 455099, China
The Second Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING

Chongqing, Chongqing Municipality, 400010, China
The Second Affiliated Hospital of Fujian Medical University
NOT_YET_RECRUITING

Quanzhou, Fujian, 362000, China
The Second Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510000, China
The Second Affiliated Hospital of Shandong First Medical University
NOT_YET_RECRUITING

Taian, Shandong, 271000, China
The Second Affiliated Hospital of the Air Force Medical University of the People's Liberation Army
NOT_YET_RECRUITING

Xi'an, Shaanxi, 710038, China
The Second People's Hospital of YiBin
NOT_YET_RECRUITING

Yibin, Sichuan, 644000, China
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING

Changsha, Hunan, 410011, China
Tianjin Cancer Hospital Airport Hospital
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, 300060, China
Tianjin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, 300060, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING

Wuhan, Hubei, 430000, China
WeiFang People's Hospital
NOT_YET_RECRUITING

Weifang, Shandong, 261000, China
Weihai Municipal Hospital
NOT_YET_RECRUITING

Weihai, Shandong, 264299, China
Xiangya Hospital Central South University
NOT_YET_RECRUITING

Changsha, Hunan, 410028, China
Xiangya Hospital ZhuZhou Central South University
NOT_YET_RECRUITING

Zhuzhou, Hunan, 412007, China
Xinjiang Medical University Cancer Hospital
NOT_YET_RECRUITING

Ürümqi, Xinjiang, 830000, China
Xinjiang Medical University Cancer Hospital
NOT_YET_RECRUITING

Ürümqi, Xinjiang, 830000, China
Yantai Yuhuangding Hospital
NOT_YET_RECRUITING

Yantai, Shandong, 264000, China
Yuncheng Central Hospital
NOT_YET_RECRUITING

Yuncheng, Shanxi, 044099, China
ZhangZhou Municipal Hospital of Fujian Province
NOT_YET_RECRUITING

Zhangzhou, Fujian, 363099, China
Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITING

Wuhan, Hubei, 430000, China
Zhongshan Hospital Xiamen university
NOT_YET_RECRUITING

Xiamen, Fujian, 361006, China
Zibo Central Hospital
NOT_YET_RECRUITING

Zibo, Shandong, China

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