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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04683679
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks for 3 doses
  • Olaparib — DRUG
    Olaparib will be administered twice daily continuously without breaks on a 21-day (3 week) cycle length, for a total of 2 cycles. Olaparib tablets will be administered bid (2 x 150 mg tablets twice daily; total 600 mg daily) on continuous days without interruption for 2 cycles. Each 3 week period constitutes one cycle.
  • Radiation — RADIATION
    The dose of radiation will be 8-9 Gy x 3 fractions. Radiation therapy will begin on C1D2-7. For tumors that are too large for this schedule, an accomodation of 30 Gy in 6 Gy per fraction is allowed, a schedule commonly used at MSK.

Study Details

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).

Key Dates

Start date
Apr 21, 2021
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Participants will have triple negative breast cancer diagnosis Treatment will be pembro + RT + olaparib
  • Experimental: Arm B (the study is amended to pause Arm B)
    Participants will have triple negative breast cancer diagnosis Treatment will be pembro + RT only
  • Experimental: Arm C (activate new arm)
    Participants will have metastatic ER+ breast cancer (ER+ MBC) Treatment will be pembro/SBRT/Olaparib)

Primary Outcome Measure

Overall Response Rate [ Time Frame: 8 weeks from baseline ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Atif Khan, MD
848-225-6334
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Atif Khan, MD
848-225-6334
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Atif Khan, MD
848-225-6334
Memorial Sloan Kettering Commack (Limited Protocol Activities)CommackNew York11725
Atif Khan, MD
848-225-6334
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Atif Khan, MD
848-225-6334
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Atif Khan, MD
848-225-6334
Atif Khan, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Nassau (All Protocol Activities)UniondaleNew York11553
Atif Khan, MD
848-225-6334

Find similar trials in Basking Ridge, NJ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
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 Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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