Trials / Active Not Recruiting
Active Not RecruitingNCT03982485
Combination Neoadjuvant Chemotherapy With or Without Apatinib for HER2 Negative Breast Cancer
Neoadjuvant Apatinib Added to Weekly Paclitaxel and Cisplatin in Patient With Locally Advanced or Early Stage HER2 Negative Breast Cancer (APP) : a Open-label, Randomized, Controlled, Trial
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 196 (actual)
- Sponsor
- RenJi Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: The combination of anti-angiogenic targeted therapy with neoadjuvant chemotherapy has been shown to further improve the pathologic response rate for HER2-negative breast cancer patients. Apatinib is a highly potent human vascular endothelial growth factor receptor 2 (VEGFR2) tyrosine kinase inhibitor that has been independently developed in China, and it can exert anti-angiogenic effects by inhibiting VEGFR2. It is unknown whether giving combination neoadjuvant chemotherapy together with apatinib is more effective in treating patients with nonmetastatic HER2-negative breast cancer. PURPOSE: To explore the efficacy and safety of apatinib added to weekly paclitaxel and cisplatin neoadjuvant therapy for HER-2 negative breast cancer patients
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apatinib | Apatinib 250mg, Oral, day 2,3,4,5,6,7, every week |
| DRUG | Paclitaxel | Paclitaxel 80mg/m2, Intravenous, day 1, 8, 15, 22, every 28 days for a cycle |
| DRUG | Cisplatin | Cisplatin 25mg/m2, Intravenous, day 1, 8, 15, every 28 days for a cycle |
| PROCEDURE | Surgery | Surgery |
Timeline
- Start date
- 2018-10-16
- Primary completion
- 2023-03-29
- Completion
- 2031-03-29
- First posted
- 2019-06-11
- Last updated
- 2024-04-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03982485. Inclusion in this directory is not an endorsement.