Brain Irradiation and Tremelimumab in Metastatic Breast Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT02563925
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brain radiotherapy or Stereotactic Radiosurgery — RADIATION
  • Tremelimumab — DRUG
  • HER2 directed therapy — DRUG
  • Durvalumab — DRUG

Study Details

The purpose of this study is to see if the combination of tremelimumab and durvalumab with brain radiation therapy can help treat this type of breast cancer that has spread to the brain.

Key Dates

Start date
Sep 18, 2015
Status verified
Jul 2020
Primary completion
Jul 14, 2021
Completion
Jul 14, 2021

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Progression Free Survival (irPFS) [ Time Frame: 12 week ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Memorial Sloan Kettering Cancer Center· New York, NY

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