Brain Irradiation and Tremelimumab in Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT02563925|
Recruitment Status : Active, not recruiting
First Posted : September 30, 2015
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Radiation: Brain radiotherapy or Stereotactic Radiosurgery Drug: Tremelimumab Drug: HER2 directed therapy Drug: Durvalumab||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Brain Irradiation and Tremelimumab in Metastatic Breast Cancer|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Radiation and Tremelimumab
Subjects will get either whole brain radiation treatment (WBRT) or stereotactic radiosurgery (SRS), as per standard of care, with tremelimumab administered every 28 days. Patients, for whom concurrent HER2 directed therapy trastuzumab is indicated, as determined by the treating investigator, will be enrolled in a parallel HER2 directed therapy trastuzumab safety cohort. Protocol Expansion: Dose 1 of tremelimumab & durvalumab (75 mg & 1500 mg, respectively) will ideally be administered 2 days prior to initiation of brain radiotherapy (or between 5 days prior & 3 days after initiation of radiotherapy). Subjects will get either WBRT or SRS, depending on the number & size of their brain metastases. Following the 1st dose, tremelimumab & duvralumab will be administered q28 days from the date of 1st tremelimumab & durvalumab administration, plus or minus 1 week, for 4 cycles. After the 4th cycle, durvalumab will be administered alone until progression of disease or unacceptable toxicity.
Radiation: Brain radiotherapy or Stereotactic Radiosurgery
Drug: HER2 directed therapy
- non-CNS disease control rate [ Time Frame: 12 week ]of the combination of tremelimumab plus brain irradiationdefined as either complete response (CR), partial response (PR), or stable disease (SD) by RECIST1.1 criteria.
- non-CNS disease control rate [ Time Frame: 12 week ]of the combination of tremelimumab, durvalumab, and HER2 directed therapy plus brain irradiation (SRS or WBRT) by RECIST 1.1 criteria.
- Immune-related progression free survival (irPFS) [ Time Frame: 12 week ]will be defined as the time from the first dose of tremelimumab until death or progressive disease, as measured by irRC.
- safety profile assessed with regular physical examination and toxicity assessment using the NCI CTCAE 4.0. Subjects will be followed with regular radiation oncology assessments as per the standard of care. [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563925
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Shanu Modi, MD||Memorial Sloan Kettering Cancer Center|