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

NCT07115095 | Completed

• 1 other identifier: KY20202039-C-1
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR)

  The proportion of patients with a complete response (CR) or partial response (PR) according to iRECIST criteria.

  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.

  After completion of Cycle 6 (each cycle is 21 days)

Secondary Outcomes (4)

• Change in Serum Carcinoembryonic Antigen (CEA) level

  Baseline and after completion of Cycle 6 (each cycle is 21 days)

• Change in Serum Carbohydrate Antigen 125 (CA125) level

  Baseline and after completion of Cycle 6 (each cycle is 21 days)

• Change in Serum Carbohydrate Antigen 153 (CA153) level

  Baseline and after completion of Cycle 6 (each cycle is 21 days)

• 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)

Study Arms (2)

Experimental: Study Group (Dual-Target Therapy)

EXPERIMENTAL

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

Active Comparator: Control Group (Single-Target Therapy)

ACTIVE COMPARATOR

Patients received TP chemotherapy combined with trastuzumab only. Treatment was administered for 6 cycles, with each cycle lasting 21 days.

Drug: TP Chemotherapy + Trastuzumab

Interventions

TP Chemotherapy + Trastuzumab + Pertuzumab DRUG

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.

Experimental: Study Group (Dual-Target Therapy)

TP Chemotherapy + Trastuzumab DRUG

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.

Active Comparator: Control Group (Single-Target Therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanlin Li: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Interventions

Trastuzumab; pertuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 11, 2025
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: August 11, 2025

Record last verified: 2025-07

Locations

CN (1)