To evaluate the efficacy and safety of neoadjuvant treatment with TQB2102 for injection in patients with Her2 positive breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 6.0 mg/kg.
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 7.5 mg/kg.
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Guizhou Cancer Hospital
Guiyang, Guizhou, China
Harbin medical university cancer hospital
Harbin, Heilongjiang, China
Total physiological complete response (tpCR)
The percentage of the patients where the primary breast lesion shows no residual infiltrating cancer and the regional lymph nodes are negative.
Time frame: Up to 12 months.
Breast pathological complete (bpCR) response
The percentage of the patients where the primary breast lesion shows no residual infiltrating cancer.
Time frame: Up to 12 months.
Objective response rate (ORR)
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.
Time frame: Up to 12 months.
Event-free survival (EFS)
The time from the date of surgery completion to the first occurrence of the following events,including disease progression precluding surgery, ipsilateral or contralateral recurrence of invasive breast cancer, regional or distant recurrence of invasive breast cancer, a second primary malignancy in a non-breast site, and death for any reason.
Time frame: Up to 60 months.
Invasive Disease-free survival (IDFS)
The time from the date of surgery completion to the first occurrence of the following events,including ipsilateral or contralateral recurrence of invasive breast cancer, regional or distant recurrence of invasive breast cancer, a second primary malignancy in a non-breast site, and death for any reason.
Time frame: Up to 60 months.
The occurrence rate of all adverse events (AEs)
The occurrence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)
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Hunan Cancer Hospital
Changsha, Hunan, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Time frame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
The severity of all adverse events (AEs)
The severity of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0).
Time frame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Anti-drug antibody (ADA)
Incidence of anti-drug antibody (ADA)
Time frame: 1 hour Before infusion on Cycle 1 Day1, Cycle 2 Day1, Cycle 4 Day1, Cycle 6 Day1, Cycle 8 Day1, and 90 days after the end of the last infusion. Each cycle is 21 days.
Overall survival (OS)
The time from the date of surgery completion to death due to any cause.
Time frame: Up to 60 months after study start