An interventional study of TP Chemotherapy + Trastuzumab + Pertuzumab and TP Chemotherapy + Trastuzumab in HER2-positive Breast Cancer, sponsored by Nanlin Li. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by Nanlin Li · Not applicable, Interventional, and Treatment
This is a prospective, randomized study to compare the efficacy of TP (Taxane plus Carboplatin) chemotherapy combined with dual-HER2 blockade (trastuzumab and pertuzumab) versus TP chemotherapy plus single-HER2 blockade (trastuzumab) in patients with HER2-positive breast cancer. The study aims to evaluate treatment response and the clinical value of serum tumor markers (CEA, CA125, and CA153) in assessing therapeutic efficacy.
Human epidermal growth factor receptor 2 (HER2)-positive breast cancer accounts for 15-20% of all breast cancers and is associated with a more aggressive disease course. Dual blockade of the HER2 pathway with trastuzumab and pertuzumab, in combination with chemotherapy, has become a standard of care. This study was designed to investigate the added benefit of pertuzumab to a regimen of TP chemotherapy and trastuzumab. Ninety-eight patients with HER2-positive breast cancer were randomized to receive either TP chemotherapy with trastuzumab and pertuzumab (Study Group) or TP chemotherapy with trastuzumab alone (Control Group). The primary objectives were to compare the overall response rate (ORR) and disease control rate (DCR) between the two arms. Secondary objectives included the evaluation of changes in serum tumor marker levels (CEA, CA125, CA153) before and after treatment, the predictive value of these markers for treatment efficacy, and the safety profile of the regimens.
This is the only study on the registry with Nanlin Li as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients received TP chemotherapy combined with trastuzumab and pertuzumab. Treatment was administered for 6 cycles, with each cycle lasting 21 days.
Drug: TP Chemotherapy + Trastuzumab + Pertuzumab
Patients received TP chemotherapy combined with trastuzumab only. Treatment was administered for 6 cycles, with each cycle lasting 21 days.
Drug: TP Chemotherapy + Trastuzumab
Chemotherapy regimen: Paclitaxel (150 mg/m²) intravenously on Day 1 and Carboplatin (400 mg/m²) intravenously on Day 2. Targeted therapy: Trastuzumab (8 mg/kg) intravenously and Pertuzumab (initial dose 840 mg, subsequent doses 420 mg) intravenously. This regimen was repeated every 21 days for 6 cycles.
Chemotherapy regimen: Paclitaxel (150 mg/m²) intravenously on Day 1 and Carboplatin (400 mg/m²) intravenously on Day 2. Targeted therapy: Trastuzumab (8 mg/kg) intravenously. This regimen was repeated every 21 days for 6 cycles.
Overall Response Rate (ORR)
The proportion of patients with a complete response (CR) or partial response (PR) according to iRECIST criteria.
Time frame: After completion of Cycle 6 (each cycle is 21 days)
Disease Control Rate (DCR)
The proportion of patients with a complete response (CR), partial response (PR), or stable disease (SD) according to iRECIST criteria.
Time frame: After completion of Cycle 6 (each cycle is 21 days)
Change in Serum Carcinoembryonic Antigen (CEA) level
Measured from serum samples. Unit: ng/mL.
Time frame: Baseline and after completion of Cycle 6 (each cycle is 21 days)
Change in Serum Carbohydrate Antigen 125 (CA125) level
Measured from serum samples. Unit: U/mL.
Time frame: Baseline and after completion of Cycle 6 (each cycle is 21 days)
Change in Serum Carbohydrate Antigen 153 (CA153) level
Measured from serum samples. Unit: U/mL.
Time frame: Baseline and after completion of Cycle 6 (each cycle is 21 days)
Incidence of Treatment-Related Adverse Events
Number of participants experiencing adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Events include liver function abnormalities, hemoglobin reduction, platelet reduction, cardiotoxicity, gastrointestinal symptoms, and joint/muscle pain.
Time frame: Monitored throughout the treatment period, from Baseline up to the completion of Cycle 6 (each cycle is 21 days)
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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