Window of Opportunity Trial of Neoadjuvant Olaparib and Durvalumab for Triple Negative or Low ER+ Breast Cancer

Sponsor
Seoul National University Hospital
Study ID
NCT03594396
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Olaparib 300mg bid will be given on days 1-28 days without rest.
  • Durvalumab — DRUG
    A fixed dose of durvalumab 1500 mg is given via IV infusion on Day 15.

Study Details

Window of Opportunity Trial of Olaparib and Durvalumab (MEDI4736) before Standard Neoadjuvant Chemotherapy for Stage II/III Triple Negative or Low ER+ Breast Cancer

Key Dates

Start date
Jun 29, 2018
Status verified
Dec 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: MEDIOLA
    Prior to the start of study medication, tumor tissue and blood will be collected as baseline. Olaparib 300mg bid will be started after the collection of tumor and blood. Olaparib will be given on days 1-28 days without rest. Tumor tissue and blood will be collected on day 14 before administration of durvalumab, to see the change in biomarkers after 2 weeks of olaparib treatment. After the acquisition of tumor and blood, durvalumab will be given in a fixed one dose of 1.5 gram on day 15. On day 29, there will be a third acquisition of tumor and blood, to see the change in biomarkers after combination treatment of olaparib and durvalumab. Tumor response will also be evaluated according to RECIST criteria version 1.1 based on CT.

Primary Outcome Measure

The changes of tumor biology [ Time Frame: 28 days ]

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