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New treatment option for Metastatic Breast Cancer
Official title A Study of Pembrolizumab and Cryoablation in People With Breast Cancer
ClinicalTrials.gov ID: NCT06246968
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, being studied as a potential treatment for metastatic breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 treatment Radiologist. Eligible cryoablation sites include (but not...
- 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...
You likely can't join if
- 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
See the full eligibility 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 treatment Radiologist. Eligible cryoablation sites include (but not limited to) soft tissue, liver, lung, and bone as determined by an...
- 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...
- 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...
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.