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

NCT ID: NCT07115095

Last Updated: 2025-08-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-01-01

Brief Summary

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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

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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.

Conditions

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HER2-positive Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

TP Chemotherapy + Trastuzumab + Pertuzumab

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

TP Chemotherapy + Trastuzumab

Intervention Type 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.

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.

Intervention Type 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. This regimen was repeated every 21 days for 6 cycles.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nanlin Li

OTHER

Sponsor Role lead

Responsible Party

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Nanlin Li

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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KY20202039-C-1

Identifier Type: -

Identifier Source: org_study_id

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