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

Official title

A Randomized, Open-label, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus TCbHP in Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression

Overview

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.

Interventions

• Drug TQB2102 for injection
  TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
• Drug Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection
  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.

Primary outcome measures

• Rate of total physiological complete response (tpCR) evaluated by Independent Review Committee (IRC) [Time frame: Up to 26 months after study start]

Secondary outcome measures (8)

• Rate of total physiological complete response (tpCR) evaluated by the investigator [Time frame: Up to 24 months after study start]
• Breast pathological complete response (bpCR) evaluated by IRC and the investigator [Time frame: Up to 26 months after study start]
• Objective response rate (ORR) [Time frame: Up to 22 months after study start]
• There year Event-free survival (EFS) [Time frame: Up to 50 months after study start]
• There year Invasive Disease-free survival (IDFS) [Time frame: Up to 50 months after study start]
• Overall Survival (OS) [Time frame: Up to 50 months after study start]
• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and indicators of abnormal laboratory tests [Time frame: From the date of signing the informed consent to 40 days after the last dosing or radical mastectomy for breast cancer or a new anti-tumor treatment, whichever comes first.]
• Incidence of Anti-drug antibody (ADA) and neutralizing antibodies (NAb) [Time frame: Up to 22 months after study start]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 78 centers

• The First Affiliated Hospital of Bengbu Medical University — Bengbu
• Anhui Provincial Cancer Hospital — Hefei
• The First Affiliated Hospital of Wannan Medical University — Wuhu
• Peking Union Medical College Hospital — Beijing
• Beijing Cancer Hospital — Beijing
• The First Affiliated Hospital of Chongqing Medical University — Chongqing
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing
• The Cancer Hospital Affiliated to Chongqing University, Chongqing Cancer Hospital, Chongqi — Chongqing
• … and 70 more centers

Identifiers

NCT: NCT07043725 · TQB2102-III-05

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗