Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA)

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT03167619
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a randomized, international, multicenter, Phase II study designed to explore the efficacy of olaparib or olaparib in combination with durvalumab in platinum-treated mTNBC. The primary objectives are to explore olaparib or olaparib in combination with durvalumab as maintenance therapy following clinical benefit with platinum-based therapy in subjects with mTNBC.

Key Dates

Start date
Oct 4, 2018
Status verified
Jun 2022
Primary completion
Jun 30, 2021
Completion
Jun 30, 2022

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A - olaparib alone
    Twice daily oral Olaparib 300mg alone as maintenance therapy until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
  • Experimental: B - olaparib plus durvalumab
    Twice daily oral olaparib plus intravenous Durvalumab every 4 weeks as maintenance therapy until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.

Primary Outcome Measure

Efficacy of Olaparib Alone as Assessed by PFS (Progression-free Survival) Reported as Events Per Month [ Time Frame: From date of randomization until the date of documented progression or date of death, whichever came first, approximately 1 year. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27705-

Find similar trials in Durham, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Duke University· Durham, NC

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