A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer

Recruiting now · Phase 3

Conditions studied: Breast Cancer

In brief

This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or docetaxel combined with trastuzumab and pertuzumab, respectively.

Key facts

Study ID

NCT07003074

Run by

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

People needed

642

Starts

2025-06-23

Expected to finish

2030-07-01

Last updated by the study team

2025-06-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• HER2 positive, recurrent or metastatic invasive breast cancer confirmed by histopathology or cell pathology
• Defined hormone receptor (HR) status
• Has not received systemic anti-tumor therapy during the recurrence/metastasis stage (acceptable ≤ first-line endocrine therapy)
• If receiving (new) adjuvant therapy, it is required that the time interval between the end of systemic therapy (excluding endocrine therapy) and the discovery of recurrence/metastasis be greater than 12 months
• Have at least one measurable lesion according to RECIST 1.1 criteria;
• Good major organ function

You may not qualify if…

• It is known that there is spinal cord compression or active central nervous system metastasis;
• Subjects with only skin and/or brain lesions as target lesions
• Combined diseases and medical history
• Have had or currently have other malignant tumors within the past 5 years of randomization
• Unrelieved toxic reactions above Common Terminology Criteria (CTC) AE grade 1 caused by any previous treatment
• Received major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to randomization
• There are diseases that affect intravenous injection and venous blood collection
• There are congenital bleeding and coagulation disorders present
• An arterial/deep vein thrombosis event occurred within 6 months prior to the first administration
• Poor blood pressure control
• Suffering from significant cardiovascular disease
• There is an uncontrolled infection of ≥ CTC AE grade 2 within 14 days before the start of treatment
• History of interstitial lung disease/pneumonia (non infectious) requiring steroid medication intervention in the past
• Individuals with moderate to severe pulmonary dysfunction/disease within 3 months prior to the first administration
• Active viral hepatitis with poor control
• Active syphilis infected individuals in need of treatment
• Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation
• Immunosuppressants or systemic or absorbable local hormone therapy are required to achieve immunosuppression
• History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases
• Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification>1.0 g
• Patients with renal failure requiring hemodialysis or peritoneal dialysis
• Poor control of diabetes
• Individuals with epilepsy who require treatment
• Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders
• Tumor related symptoms and treatment

Where it is running

• Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)
• Anhui Provincial Hospital — Hefei, Anhui, China
• Beijing Tiantan Hospital,Capital Medical University — Beijing, Beijing Municipality, China
• Gansu Provincial Cancer Hospital — Lanzhou, Gansu, China
• Gansu Provincial Cancer Hospital — Lanzhou, Gansu, China
• Shantou Central Hospital — Shantou, Guangdong, China
• Affiliated Cancer Hospital of Harbin Medical University — Harbin, Heilongjiang, China
• Huaihe Hospital of Henan University — Kaifeng, Henan, China
• Puyang Oilfield General Hospital — Puyang, Henan, China
• The Third People's Hospital of Zhengzhou — Zhengzhou, Henan, China
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China
• Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China
• The first hospital of Jilin University — Changchun, Jilin, China
• Affiliated Zhongshan Hospital Of Dalian University — Dalian, Liaoning, China
• Affiliated Zhongshan Hospital Of Dalian University — Dalian, Liaoning, China
• Liaoning Provincial Cancer Hospital — Shenyang, Liaoning, China
• The First Affiliated Hospital of Xi'An Jiaoting Yniversity — Xi'an, Shaanxi, China
• Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China
• Fudan University shanghai cancer center — Shanghai, Shanghai Municipality, China
• Shanxi Cancer Hospital — Taiyuan, Shanxi, China
• Yuncheng Central Hospital, Shanxi Province — Yuncheng, Shanxi, China
• Tianjin Cancer Hospital Airport Hospital — Tianjin, Tianjin Municipality, China
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China
• Anhui Provincial Cancer Hospital — Hefei, Anhui, China
• The Affiliated Tumor Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China

Full record on ClinicalTrials.gov

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