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

Send

Updated on 19 February 2024

See if I qualify

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	18-75 years
Treatment	Radiotherapy, Camrelizumab
Clinical Study Identifier	NCT04481763
Sponsor	Jiangxi Provincial Cancer Hospital
Last Modified on	19 February 2024

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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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cancer

breast cancer

platelet count

absolute neutrophil count

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

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Study Definition

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