Combination Neoadjuvant Chemotherapy With or Without Apatinib for HER2 Negative Breast Cancer
NCT ID: NCT03982485
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
196 participants
INTERVENTIONAL
2018-10-16
2031-03-29
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I
Apatinib+Paclitaxel+Cisplatin
Apatinib
Apatinib 250mg, Oral, day 2,3,4,5,6,7, every week
Paclitaxel
Paclitaxel 80mg/m2, Intravenous, day 1, 8, 15, 22, every 28 days for a cycle
Cisplatin
Cisplatin 25mg/m2, Intravenous, day 1, 8, 15, every 28 days for a cycle
Surgery
Surgery
Arm II
Paclitaxel+Cisplatin
Paclitaxel
Paclitaxel 80mg/m2, Intravenous, day 1, 8, 15, 22, every 28 days for a cycle
Cisplatin
Cisplatin 25mg/m2, Intravenous, day 1, 8, 15, every 28 days for a cycle
Surgery
Surgery
Interventions
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Apatinib
Apatinib 250mg, Oral, day 2,3,4,5,6,7, every week
Paclitaxel
Paclitaxel 80mg/m2, Intravenous, day 1, 8, 15, 22, every 28 days for a cycle
Cisplatin
Cisplatin 25mg/m2, Intravenous, day 1, 8, 15, every 28 days for a cycle
Surgery
Surgery
Eligibility Criteria
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Inclusion Criteria
2. Patients with histologically confirmed primary invasive breast adenocarcinoma,cT2-4N0-3M0
3. ECOG 0-1
4. HER2-negative tumor in biopsy, defined as: Immunohistochemical (IHC) 0-1+ or IHC 2+ confirmed as FISH negative.
5. Adequate organ function
Exclusion Criteria
2. Pregnant or breastfeeding patients
3. Metastatic or recurrent patients
4. Any evidence of sense or motor nerve disorders
5. Any concurrent malignancy other than breast cancer
6. Uncontrolled hypertension with hypotensive drugs therapy (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg). Patients with grade I or above myocardial ischemia or myocardial infarction or arrhythmia (including QT interval ≥ 440 ms) or cardiac insufficiency
7. Inability to swallow, gastrointestinal resection, chronic diarrhea and obstruction of the intestine, various factors which affect drug use and absorption
8. Coagulation disorders
9. Artery or venous thrombosis occurred within 6 months before the study begins
10. Have received prior treatment with a VEGFR TKI
18 Years
70 Years
FEMALE
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Principal Investigators
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Jinsong Lu, MD
Role: PRINCIPAL_INVESTIGATOR
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Locations
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Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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SHPD005
Identifier Type: -
Identifier Source: org_study_id
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