Tumor Markers for Efficacy of Dual-Target Therapy in HER2+ Breast Cancer
NCT ID: NCT07115095
Last Updated: 2025-08-11
Study Results
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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COMPLETED
NA
98 participants
INTERVENTIONAL
2021-01-01
2023-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental: Study Group (Dual-Target Therapy)
Patients received TP chemotherapy combined with trastuzumab and pertuzumab. Treatment was administered for 6 cycles, with each cycle lasting 21 days.
TP Chemotherapy + Trastuzumab + Pertuzumab
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.
Active Comparator: Control Group (Single-Target Therapy)
Patients received TP chemotherapy combined with trastuzumab only. Treatment was administered for 6 cycles, with each cycle lasting 21 days.
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. This regimen was repeated every 21 days for 6 cycles.
Interventions
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TP Chemotherapy + Trastuzumab + Pertuzumab
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.
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. This regimen was repeated every 21 days for 6 cycles.
Eligibility Criteria
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Inclusion Criteria
* Presence of measurable lesions.
* No evidence of distant metastases.
* No prior surgery or chemotherapy.
* Voluntarily signed the informed consent form.
Exclusion Criteria
* Incomplete clinical medical records.
* Presence of distant organ metastasis.
* Known allergy to study drugs.
* Expected survival of less than 3 months.
* Significant liver or kidney dysfunction.
* Presence of hematological or immune system diseases.
* Unclear pathological results.
* Concurrent other malignant tumors.
* Pregnant or lactating patients.
18 Years
FEMALE
No
Sponsors
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Nanlin Li
OTHER
Responsible Party
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Nanlin Li
Principal investigator
Locations
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Xijing Hospital
Xi'an, Shaanxi, China
Countries
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Other Identifiers
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KY20202039-C-1
Identifier Type: -
Identifier Source: org_study_id
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