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NCT Number: NCT07115095

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

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.

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Key information

Conditions

HER2-positive Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: 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.

  2. Disease Control Rate (DCR)

    Time frame: 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 outcomes

  1. Change in Serum Carcinoembryonic Antigen (CEA) level

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

    Measured from serum samples. Unit: ng/mL.

  2. Change in Serum Carbohydrate Antigen 125 (CA125) level

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

    Measured from serum samples. Unit: U/mL.

  3. Change in Serum Carbohydrate Antigen 153 (CA153) level

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

    Measured from serum samples. Unit: U/mL.

  4. Incidence of Treatment-Related Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nanlin Li

Other

Registry information

Official study title

Evaluation of Serum Tumor Markers in Assessing the Efficacy of TP Chemotherapy Combined With Trastuzumab and Pertuzumab Dual Target Therapy in HER2-Positive Breast Cancer

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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