Trials / Unknown
UnknownNCT04858529
Neoadjuvant TCHP Versus THP in Patients With HER2-positive Breast Cancer (neoCARHP Study)
Neoadjuvant TCHP Versus THP in Patients With Human Epidermal Growth Factor Receptor 2-positive Breast Cancer (neoCARHP) : a Randomized, Open-label, Multicenter, Phase III Trial
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 774 (estimated)
- Sponsor
- Guangdong Provincial People's Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2021-04-30
- Primary completion
- 2024-04-30
- Completion
- 2025-04-30
- First posted
- 2021-04-26
- Last updated
- 2023-11-07
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04858529. Inclusion in this directory is not an endorsement.