A Study of Olaparib and Pembrolizumab in People With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer
Part of paid clinical trials in Basking Ridge, New Jersey.
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Study ID
- NCT05203445
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Olaparib — DRUGOlaparib 300 mg orally BID
- Pembrolizumab — DRUGPembrolizumab 400 mg intravenously q6weeks
Study Details
This study will test any good and bad effects of combining the study drugs pembrolizumab and olaparib, given before the standard surgical procedure, to treat TNBC or HR+ HER2- breast cancers. The study drugs could shrink cancer, but they could also cause side effects. The study researchers want to find out whether the study drugs will shrink the cancer by a certain percentage compared with its current size, which may improve the outcome of surgery.
Key Dates
- Start date
- Jan 31, 2022
- Status verified
- Mar 2026
- Primary completion
- May 29, 2025
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 6 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Olaparib in Combination with PembrolizumabPembrolizumab 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.
Primary Outcome Measure
Pathologically Negative MRI-guided Biopsy [ Time Frame: 12 weeks ]
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey | 07920 | - |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown | New Jersey | 07748 | - |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey | 07645 | - |
| Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) | Commack | New York | 11725 | - |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York | 10604 | - |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | - |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale | New York | 11553 | - |
Related coverage on Hipa.ai
- Pembrolizumab + Olaparib in Breast Cancer: 5 of 6 Achieve Negative BiopsyPembrolizumab · May 29, 2026 · ClinicalTrials.gov
Find similar trials in Basking Ridge, NJ
By condition
By specialty
By research site
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY
Related Studies
- Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA MutationsRecruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast CancerPHASE2 · Recruiting · QuantumLeap Healthcare Collaborative · Birmingham, Alabama
- Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast CancerPHASE2 · Recruiting · Proton Collaborative Group · Scottsdale, Arizona
- Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and LymphomaRecruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey