Actively Recruiting
A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-17
34
Participants Needed
7
Research Sites
297 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to find out whether adding pembrolizumab, with or without olaparib, to standard radiation therapy is a safe and effective treatment for metastatic breast cancer, , and to see whether the study treatment is better than, the same as, or worse than the usual approach (radiation therapy alone).
CONDITIONS
Official Title
A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older with histologically confirmed triple-negative or ER+/Her2-negative breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 30 days prior to enrollment
- Metastatic or recurrent triple-negative or ER+ breast cancer
- Prior immune checkpoint inhibitor therapy allowed for metastatic triple-negative breast cancer with progression or PDL1-negative status
- Measurable disease based on RECIST 1.1 with at least one non-bone metastatic lesion suitable for repeated measurement
- No more than 3 prior systemic therapy lines for metastatic triple-negative breast cancer; no limit for metastatic ER+ breast cancer
- At least one tumor site suitable for palliative radiation therapy
- Provided archival or newly obtained tumor tissue samples within 30 days prior to treatment
- Not pregnant, not breastfeeding, and following contraception guidance if a woman of childbearing potential
- Adequate organ function as defined by specific laboratory values within 30 days prior to treatment
- Agreement to not breastfeed during the study and for 180 days after last dose
- Stable corticosteroid use allowed with stable dose for at least 4 weeks prior
- Ability to swallow and retain oral medications
You will not qualify if you...
- More than 3 prior systemic therapy lines for metastatic triple-negative breast cancer
- Positive pregnancy test within 72 hours (urine) or 14 days (serum) prior to treatment
- Less than 2 weeks washout from prior anticancer agents; 3-4 weeks preferred
- Prior systemic anticancer therapy or investigational agents within 2-4 weeks before treatment
- Prior radiotherapy within 2 weeks before treatment unless palliative and non-CNS
- History of grade 3 or higher immune-mediated adverse events from immunotherapy
- Live vaccine administration within 30 days prior to first dose
- Current participation or recent participation in investigational studies within 2-4 weeks
- Immunodeficiency or recent high-dose immunosuppressive therapy within 7 days
- Active malignancy requiring treatment within past 2 years (except certain skin and carcinoma in situ)
- Severe hypersensitivity to pembrolizumab, olaparib, or their excipients
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Known HIV, Hepatitis B or C, or active tuberculosis infection
- Conditions or treatments interfering with study participation or results
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnancy, breastfeeding, or intention to conceive during study and 120 days after
- History of allogenic tissue or solid organ transplant
- Uncontrolled cardiac conditions or prolonged QTc interval
- Persistent toxicities above grade 2 from prior cancer therapy
- Myelodysplastic syndrome or acute myeloid leukemia
- Symptomatic uncontrolled brain metastases or spinal cord compression without stable treatment
- Poor medical risk due to serious uncontrolled medical disorders or infections
- Inability to swallow oral medications or gastrointestinal disorders affecting absorption
- Concomitant use of strong or moderate CYP3A inhibitors or inducers without appropriate washout
- Major surgery within 2 weeks prior to treatment without full recovery
- Previous allogenic bone marrow or double umbilical cord blood transplant
- Investigator judgment of inability to comply with study requirements
- Previous enrollment in this study
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
A
Atif Khan, MD
CONTACT
S
Simon Powell, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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