Clinical trial NCT06246968: A Study of Pembrolizumab and Cryoablation in People With Breast Cancer
Official title: Does Cryoablation Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative Breast Cancer?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Breast Cancer
Breast Cancer Stage IV
Triple Negative Breast Cancer
Triple Negative Breast Neoplasms
Metastatic Triple-Negative Breast Carcinoma
Locally Advanced Breast Cancer
Locally Advanced Triple-Negative Breast Carcinoma
Keywords: metastatic TNBC
metastatic triple negative breast carcinoma
metastatic breast cancer
breast cancer
breast cancer stage IV
triple negative breast cancer
pembrolizumab
cryoablation
Memorial Sloan Kettering Cancer Center
23-390
locally advanced breast cancer
locally advanced triple negative breast carcinoma
locally advanced triple negative breast cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Change in CD4-PD1 from baseline to post-cryoablation
timeFrame: 6 weeks after cryoablation
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All protocol activites)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Yolanda Bryce, MD
role: PRINCIPAL_INVESTIGATOR
References: