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Neoadjuvant TCHP Versus THP in Patients With HER2-positive Breast Cancer (neoCARHP Study)

NCT04858529 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 774

Last updated 2023-11-07

No results posted yet for this study

Summary

The neoCARHP study was a randomized, open-label, multicenter, phase III, neoadjuvant trial. This study aimed to compare the efficacy and safety of TCHP with THP neoadjuvant setting for HER2-positive breast cancer. Patients will be randomized at a 1:1 ratio into TCHP or THP, respectively, and will be treated every 3 weeks before surgery.The primary endpoint was the percentage of pCR (ypT0/is, ypN0), which was defined as the absence of any residual invasive cancer in both the breast and axillary lymph nodes.

Conditions

  • Neoadjuvant Therapies for HER2+ Breast Cancer

Interventions

DRUG

investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP)

investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP)

DRUG

investigator-selected taxane/trastuzumab/pertuzumab (THP)

investigator-selected taxane/trastuzumab/pertuzumab (THP)

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2024-04-30
Completion
2025-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04858529 on ClinicalTrials.gov