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Trial Title:
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)
NCT ID:
NCT05999149
Condition:
TNBC - Triple-Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Camrelizumab Plus Chemotherapy and Famitinib
Description:
camrelizumab+chemotherapy (Albumin-paclitaxel plus carboplatin)+Famitinib
Arm group label:
Arm A
Other name:
camrelizumab+chemotherapy+Famitinib
Intervention type:
Drug
Intervention name:
Camrelizumab Plus Chemotherapy
Description:
Camrelizumab Plus Chemotherapy
Arm group label:
Arm B
Summary:
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 ≥10%, < 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 RECIST1.1 before surgery; subjects suitable for surgery received
surgical treatment, and pathological evaluation of tumor efficacy was performed after
surgery.
During the study treatment, if the subjects show disease progression, toxicity
intolerance, withdrawal of informed consent, or the investigator determines that
medication must be terminated, the study treatment will be terminated, and follow-up will
continue, including disease recurrence and metastasis and safety follow-up.
Participants who complete surgical treatment will be followed for at least 2 years for
event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival
(DDFS), and safety assessment. Safety data should be collected from the signing of the
informed consent until 28 days after the end of the study.
Criteria for eligibility:
Criteria:
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 ≤5 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 ≥2+ and confirmed urinary
protein quantity > 1g at 24h;
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Breast cancer institute of Fudan University Cancer Hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhi-Ming Shao, MD
Phone:
86-21-641755901105
Email:
zhimingshao@yahoo.com
Contact backup:
Last name:
Lei Fan, MD
Phone:
86-21-641755901105
Email:
cmchen@medmail.com.cn
Investigator:
Last name:
Zhi-Ming Shao, MD
Email:
Principal Investigator
Investigator:
Last name:
Li CHEN, MD
Email:
Sub-Investigator
Facility:
Name:
Fudan University Shanghai Cancer Center Shanghai, China, 200032
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhimin Shao, M.D.
Phone:
+86-021-64175590
Phone ext:
88807
Email:
zhimingshao@yahoo.com
Contact backup:
Last name:
Linxiaoxi Ma, M.D
Phone:
+86-021-64175590
Phone ext:
63169
Email:
mary2008white@126.com
Start date:
August 20, 2023
Completion date:
August 30, 2027
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05999149
