Window of Opportunity Trial of Neoadjuvant Olaparib and Durvalumab for Triple Negative or Low ER+ Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03594396|
Recruitment Status : Active, not recruiting
First Posted : July 20, 2018
Last Update Posted : June 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Drug: Olaparib Drug: Durvalumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Window of Opportunity Trial of Olaparib and Durvalumab (MEDI4736) Before Standard Neoadjuvant Chemotherapy for Stage II/III Triple Negative or Low ER+ Breast Cancer|
|Actual Study Start Date :||June 29, 2018|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||December 30, 2022|
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.
Olaparib 300mg bid will be given on days 1-28 days without rest.
Other Name: Lynparza
A fixed dose of durvalumab 1500 mg is given via IV infusion on Day 15.
- The changes of tumor biology [ Time Frame: 28 days ]The changes of tumor biology detected by serial biopsy of breast cancer before and after olaparib and durvalumab (exploratory serial biopsy study)
- pathological complete response [ Time Frame: 7 months ]Number of participants with a pathological complete response (ypT0/Tis, ypN0).
- Response rate [ Time Frame: 7 months ]Response rate by RECIST v.1.1
- Treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 7 months ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Adverse events of special interest and immune-mediated adverse events [ Time Frame: 7 months ]Adverse events of special interest and immune-mediated adverse events
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): NCT03594396
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Seock-Ah Im||Seoul National University Hospital|