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

Nanlin Li

Status: Completed

Conditions: HER2-positive Breast Cancer

Treatments: Drug: TP Chemotherapy + Trastuzumab; Drug: TP Chemotherapy + Trastuzumab + Pertuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT07115095

KY20202039-C-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Experimental: Study Group (Dual-Target Therapy)

Experimental group

Description:

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

Treatment:

Drug: TP Chemotherapy + Trastuzumab + Pertuzumab

Active Comparator: Control Group (Single-Target Therapy)

Active Comparator group

Description:

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

Treatment:

Drug: TP Chemotherapy + Trastuzumab