Description Module

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Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module

Ignite Creation Date: 2025-12-24 @ 2:12 PM
Ignite Modification Date: 2025-12-24 @ 2:12 PM
NCT ID: NCT07115095
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: NCT07115095
Study Brief:
Protocol Section: NCT07115095