RightFit
RecruitingPhase 1

A Study of Pembrolizumab and Ablation (Cryoablation or Histotripsy) in People With Breast Cancer

Does Ablation (Cryoablation or Histotripsy) Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative Breast Cancer?

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests pembrolizumab with or without ablation, a treatment that destroys cancer tissue by freezing it or using sound waves. It is for adults with triple-negative breast cancer that has spread or is locally advanced and cannot be removed by surgery. Participants are assigned by chance to receive pembrolizumab alone or with ablation.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have triple-negative breast cancer confirmed by a tissue test. The cancer must have spread to other parts of the body or be locally advanced and unable to be removed by surgery.
  • Have at least one cancer site measuring 1.5 cm or more that a specialist says can be safely treated by freezing.
  • Be physically well enough to have ablation.
  • Have pembrolizumab planned as part of usual cancer care, as the first, second, or third treatment tried. The planned dose must be 200 mg every 3 weeks.
  • Your cancer doctor must say you can receive a PD-1 inhibitor, the type of drug pembrolizumab is. Certain other cancer drugs are allowed.
  • Women who can become pregnant must use effective birth control during pembrolizumab treatment and for at least 4 months after the last dose.
  • Women who can become pregnant and are age 50 or younger must have a pregnancy test within 15 days before ablation, unless a listed medical or surgical exemption applies.

Who can't join

  • Your cancer doctor says you cannot receive a PD-1 inhibitor.
  • You have no cancer site that can be treated with ablation.
  • Pembrolizumab is not planned as part of your usual cancer care.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Patients ≥ 18 years of age * Confirmed histologic diagnosis of metastatic TNBC or locally advanced inoperable 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 ablation 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 ablation. 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 ablation. 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 ablation 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 ablation * Pembrolizumab therapy not planned as part of standard of care

Study sites (7)

NJ

NY