A Study of Pembrolizumab and Cryoablation in People With Breast Cancer

Save

Report Abuse

Description

Participants will have a confirmed diagnosis of metastatic breast cancer and will receive pembrolizumab in combination with cryoablation OR pembrolizumab alone. Participants will be randomly assigned.

Study Overview

Start Date
January 29, 2024
Completion Date
January 29, 2027
Enrollment
30
Date Posted
February 7, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920, United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey 07748, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645, United States

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
Commack, New York 11725, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604, United States

Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York 10065, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York 11553, United States

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Patients ≥ 18 years of age
Confirmed histologic diagnosis of metastatic TNBC
1 site amenable cryoablation of at least 1.5 cm in size as determined by an Interventional Radiologist. Eligible cryoablation sites include (but not limited to) soft tissue, liver, lung, and bone as determined by an Interventional Radiologist to be safest and most feasible.
Physically fit (clinically eligible) to undergo cryoablation as per usual clinical practice
Per clinical guidelines, women of childbearing age should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of the drug, which will be assessed and monitored by, and the responsibility of, the patient's medical oncologist (not study investigators or research team) as pembrolizumab is standard of care. Memorial Sloan Kettering Cancer Center Pregnancy Standards will be followed prior to cryoablation. That is, female patients that are 11-50 years of age and of childbearing potential will undergo a pregnancy test within 2 weeks (15 days) before cryoablation. Pregnancy test will not be required in patients with bilateral oophorectomy, bilateral salpingectomy, bilateral salpingectomy-oophorectomy, hysterectomy, menopause (no menses ≥ 1 year prior to treatment or after completion of all treatment), or surgical sterilization (i.e. tubal ligation or blockage), with documentation of permanent exemptions in CIS ("Pregnancy Testing Exemption").

Pembrolizumab therapy (200 mg every 3 weeks) planned as part of standard of care as first, second, or third line of therapy

Eligible for PD-1 inhibitor per the patient's medical oncologist, with planned treatment with PD-1 inhibitor per the patient's medical oncologist. Additional systemic therapy is per the patient's medical oncologist. The following systemic therapy will be accepted (the timing of the systemic therapy relative to pembrolizumab and cryoablation is not restricted):

Capecitabine (Xeloda, available as a generic drug)
Carboplatin (Paraplatin, available as a generic drug)
Cisplatin (Platinol, available as a generic drug)
Cyclophosphamide (Cytoxan, available as a generic drug)
Docetaxel (Taxotere)
Doxorubicin (Adriamycin, available as a generic drug)
Pegylated liposomal doxorubicin (Doxil)
Epirubicin (Ellence, available as a generic drug)
Eribulin (Halaven)
Fluorouracil (5-FU, Adrucil, available as a generic drug)
Gemcitabine (Gemzar, available as a generic drug)
Ixabepilone (Ixempra)
Methotrexate (available as a general drug)
Nab-paclitaxel (Abraxane)
Paclitaxel (Taxol, available as a generic drug)
Vinorelbine (Navelbine, available as a generic drug)

Exclusion Criteria:

Patient not eligible for PD-1 inhibitor per the patient's medical oncologist
No disease amenable for cryoablation
Pembrolizumab therapy not planned as part of standard of care

Study Contact Info

Study Contact Name
Yolanda Bryce, MD; Larry Norton, MD
Study Contact Phone

Contact Listings Owner Form

A Study of Pembrolizumab and Cryoablation in People With Breast Cancer 0 reviews

Write Your Review

There are no reviews yet.

Write Your Review

Your email address will not be published. Required fields are marked *

Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
NCTid (if applicable)
NCT06246968