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

NCT04481763 | Recruiting Phase 1

• 1 other identifier: JCL2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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。

Conditions

Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Invasive disease-free survival (iDFS)

  time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause

  3 years

• Invasive disease-free survival (iDFS)

  time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause

  5years

Secondary Outcomes (2)

• Overall survival (OS)

  5years

• disease-free survival (DFS)

  5 years

Study Arms (1)

camrelizumab + radiotherapy

OTHER

This is a open-labeled, single-arm, Investigator-initiated clinical trial ,Compared with historical data

Drug: Camrelizumab; Radiation: radiotherapy

Interventions

Camrelizumab DRUG

Camrelizumab is 200 mg iv. administered every 2 weeks for 3 cycles with radiotherapy ( 50gy, 25 times for 5weeks)

camrelizumab + radiotherapy

radiotherapy RADIATION

radiotherapy

camrelizumab + radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 TNBC、PD-L1expression and TMB expression
• Breast-conserving therapy is planned after mastectomy 1) largest focus must measure of Primary tumor ≥ 5cm，Tumor invades breast skin and chest wall 2) Axillary lymph node metastasis≥4 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 ≥5.6mmol/L（9.0g/dL) serum albumin ≥2.8g/dL Serum creatinine ≤ ≤1.5mg/d or creatinine clearance ≥ 50mL/min Serum Total Bilirubin ≤ 1.5 X ULN AST\&ALT≤2.5ULN
• 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.

You may not qualify if:

• 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 2 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 Ⅱ, 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 ≥ 2000 IU/ml or copy number ≥ 104/ml; hepatitis C reference: HCV antibody-positive.)

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead

Study Sites (1)

Chunling Jiang

Nanchang, Jiangxi, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

camrelizumab; Radiotherapy

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Chunling Jiang

CONTACT

+86 13764066064; jclil2002@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 22, 2020
• Study Start: July 14, 2020
• Primary Completion: August 30, 2024
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)