Metastatic Breast CancerPhase 1NCT03151447
Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Metastatic Triple Negative Breast Cancer
A Phase 1 study testing stereotactic body radiation therapy in people with Metastatic Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
The objective of this study is to evaluate the safety and tolerance of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients in Metastatic Triple Negative Breast Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- stereotactic body radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2017to Mar 2018
- Phase
- Phase 1
- 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
- Patients must be able to understand and willing to sign a written informed consent document.
- Patients with advanced triple-negative breast cancer (histologically or cytologically confirmed invasive breast carcinoma with estrogen receptor negative, progesterone receptor negative, human epidermal growth factor receptor 2 negative).
- Patients must have progressed on or been intolerant of at least prior first-line systemic treatment with anthracycline and/or taxane drugs for metastatic disease. There are no any routine regimens.
- At least 5-8 pieces of pathological tissue can be provided (for the detection of PD-L1 expression and the infiltrating lymphocytes).
- Patients must have at least one metastatic lesion with diameter> 1 cm that is amenable to SBRT, as determined by radiation oncologist.
- Patients must be able to withstand the radiotherapy process, such as maintaining the position, etc.
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- Patients must have at least 2 measurable lesions (based on RECIST V1.1);
- Female aged 18 to 75 years old are eligible.
- Weight ≥40kg
- Life expectancy ≥6 months
- ECOG performance status score of 0 or 1
- There must be at least 4 weeks since the last radiotherapy, chemotherapy, hormone therapy and molecular targeted therapy. Patients must have recovered from any toxicity related to prior therapy and the toxicity should be less than or equal to grade 1 (according to CTCAE 4.03) or returned to baseline.
- A systemic medication (such as corticosteroids) with an immunosuppressive dose (prednisone> 10 mg/d or equivalent dose) must have been discontinued for at least 2 weeks before the initiation of the study drug.
- Surgeries requiring general anesthesia must have been completed for at least 4 weeks before the initiation of the study drug. Surgeries requiring local anesthesia or epidural anesthesia must have been completed for at least 72 hours and the patients have recovered from these surgeries. Skin biopsy that needs local anesthesia must have been completed for at least 1 hour.
- The Laboratory test results must meet the following criteria:
- neutrophils ≥1.5×109/L
- Platelets ≥100×109/L
- Hemoglobin ≥90g/L (no blood transfusion within past 14 days)
- Serum Cr ≤1×ULN, endogenous creatinine clearance rate >50ml/min (Cockcroft-Gault formula)
- AST ≤2.5×ULN, ALT ≤2.5×ULN; both ALT and AST ≤5×ULN if there are liver metastasis
- Total bilirubin ≤ 1.5 × ULN (except for patients with Gilbert syndrome, the total bilirubin of those patients must be <51.3μmol/L)
- TSH, FT3, FT4 are within ± 10% of the normal range.
Who cannot join
- Evidence with active central nervous system (CNS) metastases. Patients can be included if the CNS metastasis can be treated and the neurological symptoms can be restored to a level of ≤1 degree of CTCAE (except for residual signs or symptoms associated with CNS treatment) for at least 2 weeks before the enrollment. In addition, patients must have not be treated with a corticosteroid, or just be treated with a stable dose of ≤ 10 mg prednisone/day (or equivalent dose) or with a dose reduced to 10 mg prednisone/day;
- Patients with cancerous meningitis
- The same part of body has been irradiated previously;
- Patients with active, known or suspected autoimmune diseases. Patients with the following conditions can be selected: vitiligo, type I diabetes, residual thyroid dysfunction caused by autoimmune thyroiditis that just need hormone replacement therapy, or diseases that will not relapse without external stimulating factors;
- Any prior immune checkpoint inhibition treatment with anti-PD-1/PD-L1 /PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on the T cell co-stimulus or checkpoint pathway)
- Evidence of active pulmonary tuberculosis (TB). Patients diagnosed with active tuberculosis infection within 1 year should be excluded even if they have been treated. Patients diagnosed with active tuberculosis infection for more than 1 year must be excluded unless previous anti-tuberculosis treatment is effective;
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- Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
- Complications that require immunosuppressive drugs or systemic or topical corticosteroids with immunosuppressive doses;
- Prior treatment of other study drug within past 28 days, or though the internal is more than 28 days, precious study drug is still in the 5 half-life periods;
- Inoculation of any anti-infective vaccine (such as influenza vaccine, varicella vaccine, etc.) within past 4 weeks;
- Pregnancy and breastfeeding
- Patients that can't receive intravenous puncture and/or venous access;
- History of other medical, psychological or social reasons as determined by the investigator;
- History of symptomatic interstitial lung disease or other conditions that may cause confusion when discovering or managing suspicious drug-related lung toxicity;
- Prior traditional Chinese medicine therapy with antitumor activity within past 2 weeks;
- Prior therapy with monoclonal antibodies within past 3 months (except for locally administration);
- History of other malignant tumors. (Except for non-melanoma skin cancer and the following carcinomas in situ: bladder, stomach, colon, endometrium, cervical / dysplasia, melanoma or breast cancer). Patients who have obtained complete response for at least 2 years prior to enrollment and don't need receive other treatment should be included;
- Underlying medical conditions, according to the investigator, that would increase the risks of study drug administration or obscure the interpretation of adverse events;
- Chronic hepatitis B (HBs Ag positive) or chronic hepatitis C (HCV antibody positive);
- Patients with known sensitivity or allergy to any components of humanized anti-PD-1 antibody.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Xiaomao Guo, Ph.D, guoxm1800@126.com
About this study
Official title: A Phase I Trial of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients With Metastatic Triple Negative Breast Cancer
The objective of this study is to evaluate the safety and tolerance of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients in Metastatic Triple Negative Breast Cancer
Read the detailed description
The objective of this study is to evaluate the safety and tolerance of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody（JS001） in Patients With Metastatic Triple Negative Breast Cancer
- Conditions
- Metastatic Breast Cancer
- Being tested
- stereotactic body radiation therapy
- Keywords
- Breast Cancer, Anti-PD1 Antibody, Stereotactic Body Radiation Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic body radiation therapyRadiation
In patients with metastatic triple negative breast cancer, stereotactic body radiation therapy will be combined with anti-PD-1 antibody.
Stereotactic body radiation therapy: SBRT is delivered to 1~5 measurable metastatic lesions of liver, lung, bone, brain or lymph nodes in limited fractions .
Anti-PD-1 treatment: anti-PD-1 antibody (JS001) is injected intravenously 120mg or 240mg or 360mg every two weeks.
| Study group | Role | What they receive |
|---|---|---|
| SBRT in combined with anti-PD-1 antibody | Experimental | Patients will receive stereotactic body radiation therapy to metastatic lesions of liver, lung, bone, brain or lymph nodes and concurrent anti-PD-1 antibody treatment. Receives: Radiation: stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
The incidence and severity of adverse events, clinically significant abnormal laboratory results, ECG and vital signs were assessed according to CTCAE4.03
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start6 Mar 2017
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Stereotactic Body Radiation Therapy With Concurrent Anti-PD1antibody (JS001) injected intravenously 120mg or 240mg or 360mg until disease progresses or unacceptable tolerability occurs
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaomao Guo, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151447
- Sponsor's protocol ID
- FDRT-BC005
- Status last verified
- May 2017
- First submitted
- 4 May 2017
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients With Metastatic Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT03151447
- Acronym / sponsor ID
- FDRT-BC005
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer, Anti-PD1 Antibody, Stereotactic Body Radiation Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 12 May 2017 (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.
The objective of this study is to evaluate the safety and tolerance of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients in Metastatic Triple Negative Breast Cancer
Detailed description
The objective of this study is to evaluate the safety and tolerance of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody（JS001） in Patients With Metastatic Triple Negative Breast Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stereotactic Body Radiation Therapy With Concurrent Anti-PD1antibody (JS001) injected intravenously 120mg or 240mg or 360mg until disease progresses or unacceptable tolerability occurs
| Arm | Type | Receives |
|---|---|---|
| SBRT in combined with anti-PD-1 antibody | Experimental | Radiation: stereotactic body radiation therapyPatients will receive stereotactic body radiation therapy to metastatic lesions of liver, lung, bone, brain or lymph nodes and concurrent anti-PD-1 antibody treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients must be able to understand and willing to sign a written informed consent document.
- Patients with advanced triple-negative breast cancer (histologically or cytologically confirmed invasive breast carcinoma with estrogen receptor negative, progesterone receptor negative, human epidermal growth factor receptor 2 negative).
- Patients must have progressed on or been intolerant of at least prior first-line systemic treatment with anthracycline and/or taxane drugs for metastatic disease. There are no any routine regimens.
- At least 5-8 pieces of pathological tissue can be provided (for the detection of PD-L1 expression and the infiltrating lymphocytes).
- Patients must have at least one metastatic lesion with diameter> 1 cm that is amenable to SBRT, as determined by radiation oncologist.
Key exclusion criteria (20 listed)
- Evidence with active central nervous system (CNS) metastases. Patients can be included if the CNS metastasis can be treated and the neurological symptoms can be restored to a level of ≤1 degree of CTCAE (except for residual signs or symptoms associated with CNS treatment) for at least 2 weeks before the enrollment. In addition, patients must have not be treated with a corticosteroid, or just be treated with a stable dose of ≤ 10 mg prednisone/day (or equivalent dose) or with a dose reduced to 10 mg prednisone/day;
- Patients with cancerous meningitis
- The same part of body has been irradiated previously;
- Patients with active, known or suspected autoimmune diseases. Patients with the following conditions can be selected: vitiligo, type I diabetes, residual thyroid dysfunction caused by autoimmune thyroiditis that just need hormone replacement therapy, or diseases that will not relapse without external stimulating factors;
- Any prior immune checkpoint inhibition treatment with anti-PD-1/PD-L1 /PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on the T cell co-stimulus or checkpoint pathway)
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 |
|---|---|---|
| stereotactic body radiation therapyIn patients with metastatic triple negative breast cancer, stereotactic body radiation therapy will be combined with anti-PD-1 antibody. Stereotactic body radiation therapy: SBRT is delivered to 1~5 measurable metastatic lesions of liver, lung, bone, brain or lymph nodes in limited fractions . Anti-PD-1 treatment: anti-PD-1 antibody (JS001) is injected intravenously 120mg or 240mg or 360mg every two weeks. | Radiation | SBRT in combined with anti-PD-1 antibody |
Primary outcome
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: 3 years
The incidence and severity of adverse events, clinically significant abnormal laboratory results, ECG and vital signs were assessed according to CTCAE4.03
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- 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 study testing stereotactic body radiation therapy in people with Metastatic Breast Cancer, run by Fudan University 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 22 inclusion and 20 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 12 May 2017. 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 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.
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 Xiaomao Guo (+86, guoxm1800@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (time frame: 3 years). 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 12 May 2017.