Trial Outcomes & Findings for A Study of Olaparib and Pembrolizumab in People With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer (NCT NCT05203445)
NCT ID: NCT05203445
Last Updated: 2026-05-29
Results Overview
Biopsy-confirmed radiographic complete response will be determined at the 12-week timepoint pCR/RCB0 will be determined at the time of surgery.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-05-29
Participant Flow
Participant milestones
| Measure |
Olaparib in Combination With Pembrolizumab
Pembrolizumab 400 mg will be administered as a 30 minute IV infusion every 6 weeks in conjunction with olaparib (for the first 12 weeks) and cytotoxic chemotherapy (after olaparib has been completed) if administered prior to surgery and if the patient is not deemed to have tumor growth.
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|---|---|
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Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Olaparib and Pembrolizumab in People With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Olaparib in Combination With Pembrolizumab
n=6 Participants
Pembrolizumab 400 mg will be administered as a 30 minute IV infusion every 6 weeks in conjunction with olaparib (for the first 12 weeks) and cytotoxic chemotherapy (after olaparib has been completed) if administered prior to surgery and if the patient is not deemed to have tumor growth.
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|---|---|
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Age, Continuous
|
37 years
n=51 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
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Region of Enrollment
United States
|
6 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: 12 weeksBiopsy-confirmed radiographic complete response will be determined at the 12-week timepoint pCR/RCB0 will be determined at the time of surgery.
Outcome measures
| Measure |
Olaparib in Combination With Pembrolizumab
n=6 Participants
Pembrolizumab 400 mg will be administered as a 30 minute IV infusion every 6 weeks in conjunction with olaparib (for the first 12 weeks) and cytotoxic chemotherapy (after olaparib has been completed) if administered prior to surgery and if the patient is not deemed to have tumor growth.
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|---|---|
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Pathologically Negative MRI-guided Biopsy
Partial Response
|
5 Participants
|
|
Pathologically Negative MRI-guided Biopsy
Progressive Disease
|
1 Participants
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Adverse Events
Olaparib in Combination With Pembrolizumab
Serious events: 1 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Olaparib in Combination With Pembrolizumab
n=6 participants at risk
Pembrolizumab 400 mg will be administered as a 30 minute IV infusion every 6 weeks in conjunction with olaparib (for the first 12 weeks) and cytotoxic chemotherapy (after olaparib has been completed) if administered prior to surgery and if the patient is not deemed to have tumor growth.
|
|---|---|
|
Infections and infestations
Cellulitis
|
16.7%
1/6 • 1 year
|
Other adverse events
| Measure |
Olaparib in Combination With Pembrolizumab
n=6 participants at risk
Pembrolizumab 400 mg will be administered as a 30 minute IV infusion every 6 weeks in conjunction with olaparib (for the first 12 weeks) and cytotoxic chemotherapy (after olaparib has been completed) if administered prior to surgery and if the patient is not deemed to have tumor growth.
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|---|---|
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Skin and subcutaneous tissue disorders
Rash acneiform
|
16.7%
1/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Redness to right inner thigh
|
16.7%
1/6 • 1 year
|
|
Infections and infestations
Rhinitis infective
|
16.7%
1/6 • 1 year
|
|
Injury, poisoning and procedural complications
Seroma
|
16.7%
1/6 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
1/6 • 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
16.7%
1/6 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • 1 year
|
|
Reproductive system and breast disorders
Vaginal dryness
|
16.7%
1/6 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • 1 year
|
|
Investigations
White blood cell decreased
|
16.7%
1/6 • 1 year
|
|
Injury, poisoning and procedural complications
Wound complication
|
16.7%
1/6 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
4/6 • 1 year
|
|
General disorders
Fatigue
|
83.3%
5/6 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • 1 year
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • 1 year
|
|
Vascular disorders
Hot flashes
|
16.7%
1/6 • 1 year
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • 1 year
|
|
Psychiatric disorders
Anxiety
|
33.3%
2/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • 1 year
|
|
Gastrointestinal disorders
Bloating
|
16.7%
1/6 • 1 year
|
|
Eye disorders
Blurred vision
|
16.7%
1/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
2/6 • 1 year
|
|
Infections and infestations
Breast infection
|
16.7%
1/6 • 1 year
|
|
Infections and infestations
Cellulitis
|
16.7%
1/6 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • 1 year
|
|
Infections and infestations
COVID
|
16.7%
1/6 • 1 year
|
|
Investigations
Creatinine increased
|
16.7%
1/6 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • 1 year
|
|
General disorders
Fever
|
33.3%
2/6 • 1 year
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • 1 year
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • 1 year
|
|
Investigations
Leukocyte esterase in urine
|
16.7%
1/6 • 1 year
|
|
Gastrointestinal disorders
Lip numbness
|
16.7%
1/6 • 1 year
|
|
Blood and lymphatic system disorders
Lymph node pain
|
16.7%
1/6 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
3/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
16.7%
1/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • 1 year
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
16.7%
1/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
16.7%
1/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • 1 year
|
Additional Information
Dr. Ayca Gucalp, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4536
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place