Triple-Negative Breast CancerPhase 1/2NCT04481763
A Study of the Efficacy and Safety of Camrelizumab Plus Radiotherapy for Patients With Early Triple-Negative Breast
A Phase 1/2 study testing Camrelizumab and radiotherapy in people with Triple-Negative Breast Cancer, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Triple-Negative Breast Cancer
- What is being tested?
- Camrelizumab and radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2020to 1 Oct 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.)
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chunling Jiang
Nanchang, Jiangxi
Chunling Jiang, doctor, 13979109200 ext. +086, jclil2002@163.com
About this study
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。
Read the detailed 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.
- Conditions
- Triple-Negative Breast Cancer
- Being tested
- Camrelizumab, radiotherapy
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Camrelizumab is 200 mg iv. administered every 2 weeks for 3 cycles with radiotherapy ( 50gy, 25 times for 5weeks)
radiotherapyRadiation
radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| camrelizumab + radiotherapy | Other | This is a open-labeled, single-arm, Investigator-initiated clinical trial ,Compared with historical data Receives: Drug: Camrelizumab; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5years
Secondary outcomes (2)
Overall survival (OS)
time from randomization to death from any cause
Measured: 5years
disease-free survival (DFS)
The time between randomization and recurrence of disease or (for any reason) death.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start14 Jul 2020
- Primary completion30 Aug 2024 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481763
- Sponsor's protocol ID
- JCL2020
- Status last verified
- Jul 2020
- First submitted
- 19 Jul 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Efficacy and Safety of Camrelizumab Plus Radiotherapy for Patients With Early Triple-Negative Breast
- ClinicalTrials.gov ID
- NCT04481763
- Acronym / sponsor ID
- JCL2020
- Conditions
- Triple-Negative Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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。
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| camrelizumab + radiotherapy | Other | Drug: Camrelizumab, Radiation: radiotherapyThis is a open-labeled, single-arm, Investigator-initiated clinical trial ,Compared with historical data |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (19 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CamrelizumabCamrelizumab is 200 mg iv. administered every 2 weeks for 3 cycles with radiotherapy ( 50gy, 25 times for 5weeks) | Drug | camrelizumab + radiotherapy |
| radiotherapyradiotherapy | Radiation | camrelizumab + radiotherapy |
Primary outcome
Invasive disease-free survival (iDFS)
Time frame: 3 years
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
Invasive disease-free survival (iDFS)
Time frame: 5years
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
2 secondary outcomes
Overall survival (OS)
Time frame: 5years
disease-free survival (DFS)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Camrelizumab and radiotherapy in people with Triple-Negative Breast Cancer, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunling Jiang (+86 13764066064, jclil2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive disease-free survival (iDFS) (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.