Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Metastatic Triple Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03151447|
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Radiation: stereotactic body radiation therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|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|
|Actual Study Start Date :||March 6, 2017|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
Experimental: SBRT in combined with anti-PD-1 antibody
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.
Radiation: stereotactic body radiation therapy
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151447
|Contact: Xiaomao Guoemail@example.com|
|Contact: LI Zhangfirstname.lastname@example.org|
|Fudan University Shanghai Cancer Center||Recruiting|
|Shanghai, China, 200032|
|Contact: Xiaomao Guo, Ph.D email@example.com|