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A Clinical Study of Neoadjuva...

A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

544 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2029-09-30

Brief Summary

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This is a randomized, open, positive drug control, multi center phase III study. Through the evaluation of tpCR, bpCR, ORR, EFS, IDFS, OS , AEs and other indicators, it proves the effectiveness and safety of TQB2102 for injection versus TCbHP in the neoadjuvant treatment of HER2 positive breast cancer patients.

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Detailed Description

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Conditions

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HER2-positive Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TQB2102 for injection

6mg/kg TQB2102 for injection, Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 8 cycles.

Group Type EXPERIMENTAL

TQB2102 for injection

Intervention Type DRUG

TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)

Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection

Trastuzumab injection (The first dose is 8mg/kg, followed by 6mg/kg), Pertuzumab Injection (The first dose is 840, followed by 420mg), Docetaxel Injection (75mg/m2 ) combined with Carboplatin Injection (AUC-6, 800 mg max), Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 6 cycles.

Group Type ACTIVE_COMPARATOR

Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection

Intervention Type DRUG

TCbHP is a commonly used chemotherapy scheme for HER2 positive breast cancer. H represents Trastuzumab injection, P represents Pertuzumab Injection, T represents Docetaxel injection and C represents Carboplatin injection.

Interventions

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TQB2102 for injection

TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)

Intervention Type DRUG

Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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