Actively Recruiting
Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
Led by West China Hospital · Updated on 2023-05-22
35
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
Sponsors
W
West China Hospital
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of camrelizumab in combination with apatinib and chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (TNBC).
CONDITIONS
Official Title
Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed breast cancer
- Female aged 18 to 75 years
- Early or locally advanced triple negative breast cancer confirmed by tissue tests
- Tumor stage II or III
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- At least one measurable tumor lesion according to RECIST 1.1
- Adequate blood and organ function
- Willing to use effective contraception during the study
You will not qualify if you...
- Stage IV (metastatic) or bilateral breast cancer
- Inflammatory breast cancer
- Prior anti-tumor therapy within 12 months before consent
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, CTLA-4, or anti-VEGFR agents
- History of invasive cancer within 5 years except treated skin or cervical cancers
- Major surgery within 4 weeks before study treatment
- History of autoimmune disease
- Poorly controlled hypertension
- Recent serious heart conditions within 6 months
- History of pneumonitis, interstitial lung disease, or uncontrolled systemic diseases
- Live vaccine within 28 days before treatment or planned during study
- Known HIV infection
- Active Hepatitis B, Hepatitis C, or autoimmune hepatitis
- Severe infections requiring hospitalization within 4 weeks before treatment
- Active infection needing antibiotics within 2 weeks before treatment
- Active tuberculosis within 1 year before treatment
- Prior allogeneic stem cell or organ transplant
- Peripheral neuropathy grade 2 or higher
- Clinically significant intestinal blockage
- Arterial or venous thrombosis within 3 months before enrollment
- Significant hemoptysis within 2 months before enrollment
- Significant bleeding or bleeding tendency within 3 months before enrollment
- Known bleeding or clotting disorders
- Abnormal blood clotting with bleeding risk or need for long-term blood thinners
- Known allergies to study drugs or similar antibodies
- Pregnant or breastfeeding women or women unwilling to use contraception
- History of neurological or psychiatric disorders such as epilepsy or dementia
- Any other condition judged by researchers to affect participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
T
Ting Luo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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