HER2-positive Breast Cancer
Conditions
Brief summary
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
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
DRUGTrastuzumab 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.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of total physiological complete response (tpCR) evaluated by Independent Review Committee (IRC) | Up to 26 months after study start | Rate of subjects with no residual invasive cancer in the primary breast lesion and negative regional lymph nodes upon microscopic examination after primary tumor resection, as assessed by IRC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of total physiological complete response (tpCR) evaluated by the investigator | Up to 24 months after study start | Rate of subjects with no residual invasive cancer in the primary breast lesion and negative regional lymph nodes upon microscopic examination after primary tumor resection, as assessed by the investigator. |
| Breast pathological complete response (bpCR) evaluated by IRC and the investigator | Up to 26 months after study start | Percentage of subjects with no residual invasive cancer in the primary breast lesion upon microscopic examination after primary tumor resection, as assessed by IRC and the investigator. |
| Objective response rate (ORR) | Up to 22 months after study start | The percentage of subjects achieving complete response (CR) or partial response (PR) as assessed by the investigator based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.1) . |
| There year Event-free survival (EFS) | Up to 50 months after study start | Time from randomization to the first occurrence of any of the following events: ipsilateral or contralateral invasive breast cancer recurrence, regional or distant invasive breast cancer recurrence, or death from any cause. |
| There year Invasive Disease-free survival (IDFS) | Up to 50 months after study start | Time from randomization to the first occurrence of any of the following events: ipsilateral or contralateral invasive breast cancer recurrence, regional or distant invasive breast cancer recurrence, or death from any cause. |
| Overall Survival (OS) | Up to 50 months after study start | Time from randomization to death due to any cause. |
| Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and indicators of abnormal laboratory tests | 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. | To evaluate the safety of TQB2102 for Injection compared to TCbHP in the neoadjuvant treatment of HER2 positive early breast cancer, including: the incidence and severity of adverse events (AEs), abnormal laboratory test values, and serious adverse events (SAEs). |
| Incidence of Anti-drug antibody (ADA) and neutralizing antibodies (NAb) | Up to 22 months after study start | Incidence of ADA and Nab |
Countries
China
Contacts
CONTACTZhimin Shao, Doctor
CONTACTCaigang Liu, Doctor
Outcome results
None listed