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โ† Trials
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A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)

RecruitingPhase 3Ages 18 Years - 70 YearsFemaleFudan University
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In plain words

What the trial is, and whether it could suit you

This is an open, randomized, controlled, multicenter Phase III clinical study. Eligible subjects were randomly assigned 1:1 to albumin-paclitaxel plus carboplatin and carrilizumab with or without famitinib neoadjuvant therapy. Stratification was performed at randomization according to the following factors: clinical stage of the tumor (stage II; Stage III) and CD8 expression status (IHC โ‰ฅ10%, \< 10%). Subjects who have completed neoadjuvant therapy and are suitable for surgery are required to undergo surgery. Subjects in the experimental group will continue to receive carrilizumab and famitinib until one year from the start of neoadjuvant therapy, and subjects in the control group will continue to receive carrilizumab until one year from the start of neoadjuvant therapy. Subjects who completed neoadjuvant therapy were required to undergo imaging efficacy evaluation according to RECIST1.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Inclusion Criteria: ECOG Performance Status of 0-1. Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression). Tumor stage: II-III. Adequate hematologic and organ function. Must be willing to use an adequate method of contraception for the course of the study. Exclusion Criteria: * Has a history of breast cancer. Has a history of invasive malignancy โ‰ค5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months. Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 \[CTLA-4\]. Has a diagnosis of immunodeficiency or autoimmune diseases. Has received any form of immunosuppressive therapy within 4 weeks prior to the first dose of study treatment. Severe pulmonary or cardiac disease. Known active hepatitis C virus, or known active hepatitis B virus. History of organ or bone marrow transplantation. Pregnant or breast-feeding women. Patients who have previously received VEGFR-like small molecule tyrosine kinase inhibitors (such as famitinib, sorafenib, Sunitinib, regorafenib, etc.) (except bevacizumab); Urine routine indicated urinary protein โ‰ฅ2+ and confirmed urinary protein quantity \> 1g at 24h;
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What it tests

  • Camrelizumab Plus Chemotherapy and Famitinib
  • Camrelizumab Plus Chemotherapy
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Where

2 sites
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, China
Fudan University Shanghai Cancer Center Shanghai, China, 200032
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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