A Study of the Efficacy and Safety of Camrelizumab Plus Radiotherapy for Patients With Early Triple-Negative Breast

  • STATUS
    Recruiting
  • End date
    Oct 1, 2026
  • participants needed
    20
  • sponsor
    Jiangxi Provincial Cancer Hospital
Updated on 19 February 2024
cancer
breast cancer
platelet count
absolute neutrophil count
serum pregnancy test
metastasis
neutrophil count
mastectomy
axillary lymph node dissection
triple-negative breast cancer
primary tumor
lymphadenectomy
serum bilirubin level
lymph node metastases
camrelizumab
serum total bilirubin
12 lead electrocardiogram
HER2

Summary

This is a open-labeled, single-arm, Investigator-initiated clinical trial of camrelizumab (an anti-PD-1 antibody) in combination with radiotherapy in patients with early triple-negative breast cancer. We will enroll 60 subjects. This study aims to evaluate the efficacy and safety of camrelizumab combined with radiotherapy in the treatment of early TNBC

Description

This trial is a prospective, multi-center, and exploratory clinical study, taking the Cancer Hospital of Jiangxi province as the lead unit, combined with breast cancer diagnosis and treatment norms, multi-center collaborative research to explore the iDFS of radiotherapy combined with carilizumab for triple-negative breast cancer of different subtypes and provide optimal personalized treatment options.

Details
Condition Breast Cancer, Breast Cancer, Breast Cancer - HER2 Positive, Chronic Shoulder Pain, Vaginal Atrophy
Age 18years - 75years
Treatment Radiotherapy, Camrelizumab
Clinical Study IdentifierNCT04481763
SponsorJiangxi Provincial Cancer Hospital
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

female participants aged 18 years and < 75 years
Participants with a histological or cytological diagnosis of TNBC breast cancer , defined by ER <1%, PR <1% and HER2 negative on IHC and/or non-amplified by ISH by local lab testing
Gene detection for Subtypes of TNBCPD-L1expression and TMB expression
Breast-conserving therapy is planned after mastectomy 1) largest focus must measure of Primary tumor 5cmTumor invades breast skin and chest wall 2) Axillary lymph node metastasis4 3) 1 -3 lymph node metastases in stage T1-2 4) Simple mastectomy combined with axillary lymphadenectomy in stage T1-2 (axillary lymph nodes are positive, and subsequent axillary dissection is not considered)
Adequate Organ Function as defined in the table below
Absolute neutrophil count (ANC) 1500/uL Platelet count 100,000/uL Hemoglobin
6mmol/L9.0g/dL) serum albumin 2.8g/dL Serum creatinine 1.5mg/d or creatinine
clearance 50mL/min Serum Total Bilirubin 1.5 X ULN AST&ALT2.5ULN
\. 12 lead ECG: friderica corrected QT interval (QTCF) < 470 Ms
\. Women of childbearing potential must have a negative urine or serum
pregnancy test within 28 day prior to registration; women/men of reproductive
potential must have agreed to use an effective contraceptive method for the
course of the study through 90 days after the last dose of study medication
\. Written informed consent obtained from subject and ability for subject to
comply with the requirements of the study

Exclusion Criteria

Known additional malignancy that is progressing or has required active treatment
Note: Participants with basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical
cancer in situ) that have undergone potentially curative therapy are not
excluded
\. Patients with evident metastatic lesions at the time of diagnosis
\. Has received prior therapy with an anti-PD-1, anti-PD-L1.History of severe
allergic, anaphylactic, or other hypersensitivity reactions to chimeric or
humanized antibodies or fusion proteins
\. There are any active autoimmune diseases or a medical history of
autoimmune (including, but not limited to: autoimmune hepatitis, interstitial
pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis
nephritis, hyperthyroidism, thyroid function Decreased. Subjects with vitiligo
or adults who have had childhood asthma but have fully relieved without any
intervention may be included. However, subjects who require bronchodilators
for medical intervention cannot be included.)
\. Active autoimmune disease that has required systemic treatment in the past
years (i.e. with use of disease modifying agents, corticosteroids or
immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency, etc.) is not considered a form of systemic treatment
\. Ascites or pleural effusion with clinical symptoms, requiring therapeutic
puncture or drainage
\. Cardiac clinical symptoms or diseases that are not well controlled, such
as: a. Heart Failure NYHA > Class , b. unstable angina, c. myocardial
infarction within 1 year; d. Clinically significant supraventricular or
ventricular arrhythmia requiring treatment or intervention
\. Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), with
obvious bleeding tendency or undergoing thrombolytic or anticoagulant
treatment
\. History of clear tendency of gastrointestinal hemorrhage and active
bleeding in unresected tumor within 3 months prior to the start of study
treatment. for example, esophageal varices, gastric and duodenal active ulcer
ulcerative colitis, portal hypertension ; Or other conditions that may cause
gastrointestinal bleeding and perforation determined by the researchers
\. Previous or current serious bleeding (bleeding > 30ml in 3 months)
hemoptysis (fresh blood > 5ml in 4 weeks) or thromboembolism within 12 months
(including stroke events and / or transient ischemic attacks)
\. The patient has active infection during screening period, or unexplained
fever (38.5 C) before first administration ( According to the judgment of the
researcher, the fever caused by the tumor can be included in the group)
\. Abdominal fistula, gastrointestinal perforation or intraperitoneal
abscess within 4 weeks prior to the start of study treatment
\. Has a history of idiopathic pulmonary fibrosis (including pneumonitis)
drug-induced pneumonitis, organising pneumonia (i.e., bronchiolitis
obliterans, cryptogenic organizing pneumonia), or evidence of active
pneumonitis on screening chest CT scan
\. Subjects with congenital or acquired immunodeficiency (such as HIV-
infected), or active hepatitis (hepatitis B reference: HBsAg-positive, HBV DNA
IU/ml or copy number 104/ml; hepatitis C reference: HCV antibody-
positive.)
\. Patients who are participating in other clinical trials or less than 1
month from the end of the previous clinical study; Patients may receive other
systemic anti-tumor treatment during the study period
\. Receive live vaccine within 4 weeks before or during the study period
\. Has known psychiatric or substance abuse disorders that would interfere
with cooperation with the requirements of the trial
\. According to the investigator's assessment, there are other factors that
may lead to the termination of the study, such as other serious diseases
(including mental illness) requiring combined treatment. Any other condition
and social/psychological problems, etc., the investigator judged that the
patient was not suitable for participation in the study
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