Tumor Markers for Efficacy of Dual-Target Therapy in HER2+ Breast Cancer

Not Applicable

Completed

• Conditions: HER2-positive Breast Cancer
• Interventions: Drug: TP Chemotherapy + Trastuzumab + Pertuzumab; Drug: TP Chemotherapy + Trastuzumab

• Registration Number: NCT07115095
• Lead Sponsor: Nanlin Li

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-27
• Study First Submitted QC: 2025-08-03
• Last Update Submitted: 2025-08-03
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 98

Inclusion Criteria

• Confirmed HER2-positive breast cancer.
• Presence of measurable lesions.
• No evidence of distant metastases.
• No prior surgery or chemotherapy.
• Voluntarily signed the informed consent form.

Exclusion Criteria

• Incomplete neoadjuvant therapy.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Study Group (Dual-Target Therapy)	TP Chemotherapy + Trastuzumab + Pertuzumab	Patients received TP chemotherapy combined with trastuzumab and pertuzumab. Treatment was administered for 6 cycles, with each cycle lasting 21 days.
Active Comparator: Control Group (Single-Target Therapy)	TP Chemotherapy + Trastuzumab	Patients received TP chemotherapy combined with trastuzumab only. Treatment was administered for 6 cycles, with each cycle lasting 21 days.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	After completion of Cycle 6 (each cycle is 21 days)	The proportion of patients with a complete response (CR) or partial response (PR) according to iRECIST criteria.
Disease Control Rate (DCR)	After completion of Cycle 6 (each cycle is 21 days)	The proportion of patients with a complete response (CR), partial response (PR), or stable disease (SD) according to iRECIST criteria.

Secondary Outcome Measures

Name	Time	Method
Change in Serum Carcinoembryonic Antigen (CEA) level	Baseline and after completion of Cycle 6 (each cycle is 21 days)	Measured from serum samples. Unit: ng/mL.
Change in Serum Carbohydrate Antigen 125 (CA125) level	Baseline and after completion of Cycle 6 (each cycle is 21 days)	Measured from serum samples. Unit: U/mL.
Change in Serum Carbohydrate Antigen 153 (CA153) level	Baseline and after completion of Cycle 6 (each cycle is 21 days)	Measured from serum samples. Unit: U/mL.
Incidence of Treatment-Related Adverse Events	Monitored throughout the treatment period, from Baseline up to the completion of Cycle 6 (each cycle is 21 days)	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.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China