Last reviewed · How we verify

NCT03025035

Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer

Completed Phase 2 Results posted Last updated 6 February 2026
What this trial tests

Phase 2 trial testing Pembrolizumab in Breast Cancer in 14 participants. Completed in 21 November 2025.

Timeline
10 September 2017
Primary endpoint
8 October 2024
21 November 2025

Quick facts

Lead sponsorYuan Yuan
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment14
Start date10 September 2017
Primary completion8 October 2024
Estimated completion21 November 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Yuan Yuan — full company profile →

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Response Rate (ORR) Per RECIST1.1 Primary · Up to 2 Years

Defined as complete or partial response or stable disease per RECIST 1.1 criteria with assessment every 9 weeks during the first year and while on the study drug, and every 12 weeks thereafter. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), a tumor that is neither shrinking sufficiently to be considered a partial response (PR) (at least 30% decrease in tumor

GroupValue95% CI
Pembrolizumab + Olaparib7

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events are collected for up to two years of total study participation.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pembrolizumab + Olaparib
Serious: 0/11 (0%)
Deaths: 6/11
Other adverse events (48 terms — click to expand)

ReactionSystemPembrolizumab + Olaparib
NauseaGastrointestinal disorders
Anemia HemoglobinBlood and lymphatic system disorders
FatigueGeneral disorders
HeadacheNervous system disorders
Back PainMusculoskeletal and connective tissue disorders
ConstipationGastrointestinal disorders
DiarrheaGastrointestinal disorders
VomitingGastrointestinal disorders
AnorexiaMetabolism and nutrition disorders
DizzinessNervous system disorders
DysgeusiaNervous system disorders
Edema LimbsGeneral disorders
FallInjury, poisoning and procedural complications
HyperthyroidismEndocrine disorders
PainGeneral disorders
AnorexiaGastrointestinal disorders
AnxietyPsychiatric disorders
BloatingGastrointestinal disorders
Blood Bilirubin IncreasedBlood and lymphatic system disorders
Concentration ImpairmentNervous system disorders
CoughRespiratory, thoracic and mediastinal disorders
Creatinine increasedRenal and urinary disorders
DysgeusiaGastrointestinal disorders
Eye disorders - OtherEye disorders
Eye painEye disorders
Eyelid Function DisorderEye disorders
Flank PainMusculoskeletal and connective tissue disorders
Gastroesophagael RefluxGastrointestinal disorders
HypercalcemiaMetabolism and nutrition disorders
InsomniaPsychiatric disorders
Joint Range of Motion DecreasedMusculoskeletal and connective tissue disorders
MalaiseGeneral disorders
Mucositis OralGastrointestinal disorders
MyalgiaMusculoskeletal and connective tissue disorders
Non-Cardiac Chest PainGeneral disorders
Oral PainGastrointestinal disorders
Other- Pain at Biopsy SiteGeneral disorders
Other- TinnitusEar and labyrinth disorders
Other- Muscle CrampsMusculoskeletal and connective tissue disorders
Pain in ExtremityMusculoskeletal and connective tissue disorders

Data from ClinicalTrials.gov NCT03025035 adverse events section.

Sponsor's own description

This trial will evaluate the use of immunotherapy and PARP inhibition in a population with incurable advanced breast cancer associated with a germline BRCA mutation or HDR-defect. The main objective is to examine overall response rate of pembrolizumab (immunotherapy) in combination with Olaparib (PARP inhibitor) in advanced BRCA-mutated or Homology-directed repair (HDR)-defect breast cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Breast Cancer Treatments: Updates and New Challenges.
    Burguin A, Diorio C, Durocher F. · · 2021 · cited 297× · PMID 34442452 · DOI 10.3390/jpm11080808
  2. Immunologic tumor microenvironment modulators for turning cold tumors hot.
    Khosravi GR, Mostafavi S, Bastan S, Ebrahimi N, et al · · 2024 · cited 182× · PMID 38551889 · DOI 10.1002/cac2.12539
  3. How shall we treat early triple-negative breast cancer (TNBC): from the current standard to upcoming immuno-molecular strategies.
    Park JH, Ahn JH, Kim SB. · · 2018 · cited 109× · PMID 29765774 · DOI 10.1136/esmoopen-2018-000357
  4. Targeting DNA repair pathway in cancer: Mechanisms and clinical application.
    Wang M, Chen S, Ao D. · · 2021 · cited 84× · PMID 34977872 · DOI 10.1002/mco2.103
  5. Association of BRCA1- and BRCA2-deficiency with mutation burden, expression of PD-L1/PD-1, immune infiltrates, and T cell-inflamed signature in breast cancer.
    Wen WX, Leong CO. · · 2019 · cited 84× · PMID 31022191 · DOI 10.1371/journal.pone.0215381
  6. The role of DNA damage repair (DDR) system in response to immune checkpoint inhibitor (ICI) therapy.
    Shi C, Qin K, Lin A, Jiang A, et al · · 2022 · cited 60× · PMID 36071479 · DOI 10.1186/s13046-022-02469-0
  7. Role of DNA repair defects in predicting immunotherapy response.
    Zhang J, Shih DJH, Lin SY. · · 2020 · cited 57× · PMID 32612833 · DOI 10.1186/s40364-020-00202-7
  8. PARP inhibitors as single agents and in combination therapy: the most promising treatment strategies in clinical trials for BRCA-mutant ovarian and triple-negative breast cancers.
    Luo L, Keyomarsi K. · · 2022 · cited 56× · PMID 35435784 · DOI 10.1080/13543784.2022.2067527

Verify or expand the search:

Other trials of Pembrolizumab

Trials testing the same drug.

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03025035.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing