Trial Outcomes & Findings for Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer (NCT NCT03025035)

Last Updated: 2025-12-02

Results Overview

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 burden), nor growing significantly enough to be considered progressive disease (PD) (more than 20% increase in tumor burden); Overall Response (OR) = CR + PR + SD

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Up to 2 Years

Results posted on

2025-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	Pembrolizumab + Olaparib This is an open-label, single-arm pilot study of pembrolizumab (study drug) in combination with Olaparib in 20 subjects with advanced BRCA mutation and/or HDR-defect associated breast cancer having progressed through at least a standard first line therapy. Pembrolizumab: Pembrolizumab IV solution administered on Day 1 of each 3-week cycle Olaparib: Olaparib administered orally twice a day
Overall Study STARTED	14
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab + Olaparib This is an open-label, single-arm pilot study of pembrolizumab (study drug) in combination with Olaparib in 20 subjects with advanced BRCA mutation and/or HDR-defect associated breast cancer having progressed through at least a standard first line therapy. Pembrolizumab: Pembrolizumab IV solution administered on Day 1 of each 3-week cycle Olaparib: Olaparib administered orally twice a day
Overall Study Death	2
Overall Study Disease progression and was taken off study. Only received pembrolizumab & is not evaluable.	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab + Olaparib n=11 Participants This is an open-label, single-arm pilot study of pembrolizumab (study drug) in combination with Olaparib in 20 subjects with advanced BRCA mutation or HDR-defect associated breast cancer having progressed through at least a standard first line therapy. Pembrolizumab: Pembrolizumab IV solution administered on Day 1 of each 3-week cycle Olaparib: Olaparib administered orally twice a day
Age, Categorical <=18 years	0 Participants n=121 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=121 Participants
Age, Categorical >=65 years	4 Participants n=121 Participants
Age, Continuous	54.45455 years STANDARD_DEVIATION 13.09476 • n=121 Participants
Sex: Female, Male Female	11 Participants n=121 Participants
Sex: Female, Male Male	0 Participants n=121 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=121 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=121 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=121 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=121 Participants
Race (NIH/OMB) Asian	1 Participants n=121 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=121 Participants
Race (NIH/OMB) Black or African American	1 Participants n=121 Participants
Race (NIH/OMB) White	8 Participants n=121 Participants
Race (NIH/OMB) More than one race	1 Participants n=121 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=121 Participants
Region of Enrollment United States	11 participants n=121 Participants

PRIMARY outcome

Timeframe: Up to 2 Years

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=11 Participants This is an open-label, single-arm pilot study of pembrolizumab (study drug) in combination with Olaparib in 20 subjects with advanced BRCA mutation or HDR-defect associated breast cancer having progressed through at least a standard first line therapy. Pembrolizumab: Pembrolizumab IV solution administered on Day 1 of each 3-week cycle Olaparib: Olaparib administered orally twice a day
Overall Response Rate (ORR) Per RECIST1.1	7 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Other adverse events

Other adverse events
Measure	Pembrolizumab + Olaparib n=11 participants at risk This is an open-label, single-arm pilot study of pembrolizumab (study drug) in combination with Olaparib in 20 subjects with advanced BRCA mutation or HDR-defect associated breast cancer having progressed through at least a standard first line therapy. Pembrolizumab: Pembrolizumab IV solution administered on Day 1 of each 3-week cycle Olaparib: Olaparib administered orally twice a day
General disorders Malaise	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Gastrointestinal disorders Mucositis Oral	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Musculoskeletal and connective tissue disorders Myalgia	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Gastrointestinal disorders Nausea	72.7% 8/11 • Number of events 8 • Adverse events are collected for up to two years of total study participation.
General disorders Non-Cardiac Chest Pain	9.1% 1/11 • Number of events 2 • Adverse events are collected for up to two years of total study participation.
Gastrointestinal disorders Oral Pain	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
General disorders Other- Pain at Biopsy Site	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Ear and labyrinth disorders Other- Tinnitus	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Musculoskeletal and connective tissue disorders Other- Muscle Cramps	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
General disorders Pain	18.2% 2/11 • Number of events 2 • Adverse events are collected for up to two years of total study participation.
Musculoskeletal and connective tissue disorders Pain in Extremity	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Cardiac disorders Palpitations	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Cardiac disorders Paresthesia	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Nervous system disorders Peripheral Sensory Neuropathy	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Respiratory, thoracic and mediastinal disorders Postnasal Drip	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Gastrointestinal disorders Stomach Pain	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Vascular disorders Thromboembolic Event	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Gastrointestinal disorders Vomiting	27.3% 3/11 • Number of events 4 • Adverse events are collected for up to two years of total study participation.
Injury, poisoning and procedural complications White blood cell decreased	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
General disorders Other- Injection Site Pain (Intermittent)	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Blood and lymphatic system disorders Anemia Hemoglobin	54.5% 6/11 • Number of events 14 • Adverse events are collected for up to two years of total study participation.
Metabolism and nutrition disorders Anorexia	18.2% 2/11 • Number of events 2 • Adverse events are collected for up to two years of total study participation.
Gastrointestinal disorders Anorexia	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Psychiatric disorders Anxiety	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Musculoskeletal and connective tissue disorders Back Pain	27.3% 3/11 • Number of events 3 • Adverse events are collected for up to two years of total study participation.
Gastrointestinal disorders Bloating	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Blood and lymphatic system disorders Blood Bilirubin Increased	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Nervous system disorders Concentration Impairment	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Gastrointestinal disorders Constipation	27.3% 3/11 • Number of events 3 • Adverse events are collected for up to two years of total study participation.
Respiratory, thoracic and mediastinal disorders Cough	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Renal and urinary disorders Creatinine increased	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Gastrointestinal disorders Diarrhea	27.3% 3/11 • Number of events 3 • Adverse events are collected for up to two years of total study participation.
Nervous system disorders Dizziness	18.2% 2/11 • Number of events 2 • Adverse events are collected for up to two years of total study participation.
Nervous system disorders Dysgeusia	18.2% 2/11 • Number of events 2 • Adverse events are collected for up to two years of total study participation.
Gastrointestinal disorders Dysgeusia	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
General disorders Edema Limbs	18.2% 2/11 • Number of events 2 • Adverse events are collected for up to two years of total study participation.
Eye disorders Eye disorders - Other	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Eye disorders Eye pain	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Eye disorders Eyelid Function Disorder	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Injury, poisoning and procedural complications Fall	18.2% 2/11 • Number of events 2 • Adverse events are collected for up to two years of total study participation.
General disorders Fatigue	36.4% 4/11 • Number of events 4 • Adverse events are collected for up to two years of total study participation.
Musculoskeletal and connective tissue disorders Flank Pain	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Gastrointestinal disorders Gastroesophagael Reflux	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Nervous system disorders Headache	36.4% 4/11 • Number of events 4 • Adverse events are collected for up to two years of total study participation.
Metabolism and nutrition disorders Hypercalcemia	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Endocrine disorders Hyperthyroidism	18.2% 2/11 • Number of events 2 • Adverse events are collected for up to two years of total study participation.
Psychiatric disorders Insomnia	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.
Musculoskeletal and connective tissue disorders Joint Range of Motion Decreased	9.1% 1/11 • Number of events 1 • Adverse events are collected for up to two years of total study participation.

Additional Information

Yuan Yuan, MD, PhD

Cedars-Sinai Medical Center

Phone: 3108888680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place