Actively Recruiting
A Study of the Efficacy and Safety of Camrelizumab Plus Radiotherapy for Patients With Early Triple-Negative Breast Cancer
Led by Jiangxi Provincial Cancer Hospital · Updated on 2020-07-22
20
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of camrelizumab, an anti-PD-1 antibody, with radiotherapy in patients with early triple-negative breast cancer (TNBC). This open-label, single-arm clinical trial aims to assess the effectiveness and safety of this combined treatment approach. The study is designed to explore invasive disease-free survival (iDFS) over 3 and 5 years and provide personalized treatment options for different TNBC subtypes. Participants will receive camrelizumab at a dose of 200 mg intravenously every two weeks for three cycles alongside radiotherapy consisting of 50 Gy administered in 25 treatments over five weeks. The trial is conducted across multiple centers with the Cancer Hospital of Jiangxi Province as the lead unit. This study compares results with historical data and focuses on optimizing treatment for early TNBC. During the study, participants will undergo various assessments, including gene detection for TNBC subtypes, PD-L1 expression, and tumor mutational burden. Organ function tests, ECGs, and pregnancy tests will monitor safety. Researchers will evaluate disease-free and overall survival over five years. Participants will provide informed consent and comply with study requirements throughout the trial duration, which runs until 2026.
CONDITIONS
Brief Title
A Study of the Efficacy and Safety of Camrelizumab Plus Radiotherapy for Patients With Early Triple-Negative Breast
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older and under 75 years
- Histological or cytological diagnosis of triple-negative breast cancer defined by ER <1%, PR <1%, and HER2 negative
- Gene detection for TNBC subtypes, PD-L1 expression, and tumor mutational burden
- Planned breast-conserving therapy or mastectomy with specific tumor size and lymph node involvement criteria
- Adequate organ function with specified blood counts and biochemical parameters
- Fridericia corrected QT interval (QTCF) less than 470 ms on 12 lead ECG
- Negative pregnancy test for women of childbearing potential within 28 days prior to registration
- Agreement to use effective contraception during the study and for 90 days after last dose
- Ability to provide written informed consent and comply with study requirements
You will not qualify if you...
- Known additional progressing malignancy requiring active treatment, except certain treated skin or in situ cancers
- Presence of metastatic lesions at diagnosis
- Prior therapy with anti-PD-1 or anti-PD-L1 agents or history of severe allergic reactions to such antibodies
- Active autoimmune diseases or recent systemic treatment for autoimmune conditions
- Ascites or pleural effusion requiring therapeutic drainage
- Uncontrolled cardiac conditions including recent myocardial infarction or significant arrhythmias
- Abnormal coagulation or bleeding disorders
- Recent serious bleeding events or conditions increasing risk of gastrointestinal hemorrhage
- Active infection or unexplained fever above 38.5°C before treatment
- Recent abdominal fistula, gastrointestinal perforation, or intraperitoneal abscess
- History or evidence of active pneumonitis or pulmonary fibrosis
- Congenital or acquired immunodeficiency or active hepatitis B or C
- Participation in other clinical trials within one month or receiving systemic anti-tumor treatment during the study
- Receipt of live vaccine within four weeks before or during the study
- Psychiatric or substance abuse disorders interfering with study compliance
- Other serious diseases or conditions judged by investigators to be unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 5 weeks
Participants receive Camrelizumab every 2 weeks for 3 cycles combined with radiotherapy given as 25 sessions over 5 weeks.
Multiple visits during radiotherapy and drug administration
Trial Site Locations
Total: 1 location
1
Chunling Jiang
Nanchang, Jiangxi, China
Actively Recruiting
Research Team
C
Chunling Jiang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here