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PARP Inhibitor

Olaparib Oral Product in combination with Durvalumab for Breast Cancer (DORA Trial)

Phase 2
Waitlist Available
Led By Sarah Sammons, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to provide a representative formalin-fixed, paraffin embedded tumour specimen archival or fresh tissue for correlative studies and biomarker analysis.
ECOG performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 8 weeks from date of randomization until documented disease progression or last patient contact, approximately 1 year
Awards & highlights

DORA Trial Summary

This trial is testing the effectiveness of olaparib or olaparib in combination with durvalumab in treating platinum-treated mTNBC.

Eligible Conditions
  • Breast Cancer

DORA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

DORA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 8 weeks from date of randomization until documented disease progression or last patient contact, approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 8 weeks from date of randomization until documented disease progression or last patient contact, approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of Olaparib Alone as Assessed by PFS (Progression-free Survival) Reported as Events Per Month
Efficacy of Olaparib in Combination With Durvalumab as Assessed by PFS (Progression-free Survival)
Secondary outcome measures
Chromium
Clinical Benefit Rate (CBR) as Measured by the Number of Participants Achieving Complete Response (CR), Partial Response (PR) or Stable Disease for ≥ 24 Weeks (SD) as Defined by RECIST 1.1. (Olaparib in Combination With Durvalumab)
Overall Response Rate (ORR) as Measured by Number of Participants Achieving Complete Response (CR) or Partial Response (PR) as Defined by RECIST 1.1 (Olaparib Alone)
+3 more

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT03167619
41%
Decreased appetite
41%
Nausea
32%
Vomiting
32%
Cough
32%
Anaemia
27%
Fatigue
27%
Headache
23%
Dizziness
23%
Diarrhoea
18%
Neutrophil count decreased
18%
Peripheral sensory neuropathy
14%
Hypoalbuminaemia
14%
Dyspnoea
14%
Platelet count decreased
14%
Arthralgia
14%
Dry mouth
14%
Mucosal inflammation
14%
Pyrexia
9%
Non-cardiac chest pain
9%
Hypokalaemia
9%
Pneumonitis
9%
Rash
9%
Pain
9%
Constipation
9%
Insomnia
9%
White blood cell count decreased
9%
Hypothyroidism
9%
Oral pain
9%
Chills
9%
Influenza like illness
9%
Rhinorrhoea
9%
Myalgia
5%
Pneumonia
5%
Dyspepsia
5%
Neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
B - Olaparib Plus Durvalumab
A - Olaparib Alone

DORA Trial Design

2Treatment groups
Experimental Treatment
Group I: B - olaparib plus durvalumabExperimental Treatment1 Intervention
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.
Group II: A - olaparib aloneExperimental Treatment1 Intervention
Twice daily oral Olaparib 300mg alone as maintenance therapy until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Olaparib
FDA approved

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,242 Previous Clinical Trials
288,525,183 Total Patients Enrolled
174 Trials studying Breast Cancer
1,246,339 Patients Enrolled for Breast Cancer
Duke UniversityLead Sponsor
2,351 Previous Clinical Trials
3,407,789 Total Patients Enrolled
54 Trials studying Breast Cancer
9,951 Patients Enrolled for Breast Cancer
Sarah Sammons, MDPrincipal InvestigatorDuke Cancer Institute
5 Previous Clinical Trials
184 Total Patients Enrolled
2 Trials studying Breast Cancer
117 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~7 spots leftby Mar 2025