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Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer (Breast-48)

This study is currently recruiting participants.
Verified September 2017 by Patrick Dillon, MD, University of Virginia
Sponsor:
ClinicalTrials.gov Identifier:
NCT03237572
First Posted: August 2, 2017
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Patrick Dillon, MD, University of Virginia
  Purpose
This pilot study evaluates the use of high-intensity focused ultrasound (HIFU) combined with pembrolizumab in patients with metastatic breast cancer. One-half of participants will be randomized to receive the first dose of pembrolizumab after HIFU and one-half of participants will be randomized to receive their first dose of pembrolizumab before HIFU.

Condition Intervention Phase
Breast Cancer Drug: Pembrolizumab Device: High-intensity focused ultrasound (HIFU) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Pilot, 2-arm randomized study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Focused Ultrasound Therapy to Augment Antigen Presentation and Immune-Specificity of Checkpoint Inhibitor Therapy With Pembrolizumab in Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Patrick Dillon, MD, University of Virginia:

Primary Outcome Measures:
  • Change in tumor infiltrating lymphocytes [ Time Frame: baseline and week 4 ]
    Change in proportion of CD8+ tumor infiltrating lymphocytes (ration CD8+/CD4+) in the primary ablation zone


Secondary Outcome Measures:
  • Adverse event profile of pembrolizumab and HIFU [ Time Frame: From date of randomization through 30 days following cessation of treatment ]
    Toxicities from the combination of pembrolizumab and HIFU


Estimated Enrollment: 15
Actual Study Start Date: September 25, 2017
Estimated Study Completion Date: November 25, 2021
Estimated Primary Completion Date: September 16, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: 1st dose of pembrolizumab after HIFU
Pembrolizumab (200 mg) administered intravenously, days 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.
Drug: Pembrolizumab
Pembrolizumab (200 mg)
Other Name: Keytruda
Device: High-intensity focused ultrasound (HIFU)
Ablation will target 50% of the tumor, up to 3 cubic centimeters
Experimental: Arm B: 1st dose of pembrolizumab before HIFU
Pembrolizumab (200 mg) intravenously, days 1, 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.
Drug: Pembrolizumab
Pembrolizumab (200 mg)
Other Name: Keytruda
Device: High-intensity focused ultrasound (HIFU)
Ablation will target 50% of the tumor, up to 3 cubic centimeters

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (summary):

  • Histologically confirmed metastatic or unresectable breast cancer
  • Any receptor status (estrogen receptor, progesterone receptor, HER2 receptor). Patients who are HR+ should also no longer be candidates for hormonal-based therapy. Patients who are HER2+ should have progressed on or no longer be candidates for available HER2 directed therapy. Hormonal therapy must be stopped prior to day 1 of treatment.
  • Patients must have had at least one prior line of therapy for breast cancer in the metastatic setting.
  • Patients must have an accessible lesion in the breast/chest wall/axilla which has not been previously thermally ablated. Prior breast irradiation is acceptable if the lesion has recurred or grown following radiation.
  • Patients must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication.
  • Patients must have at least one target lesion in breast/chest wall/axilla which is amenable to application of high intensity focused ultrasound:
  • Patients must be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.
  • Performance status of 0 or 1 on the ECOG Performance Scale.
  • Adequate organ function

Exclusion Criteria (summary):

  • Patients currently participating and receiving study therapy or patients who have participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • Patients with a diagnosis of immunodeficiency, patients receiving systemic steroid therapy or, patients who have received any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Patients with a known history of active Tuberculosis
  • Hypersensitivity to pembrolizumab or any of its excipients
  • Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1. Patients who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier are excluded.
  • Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1. Patients who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Active autoimmune disease that has required systemic treatment in the past 2 years.
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Active infection requiring systemic therapy.
  • Pregnancy
  • Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent within the prior 24 weeks.
  • Known history of Human Immunodeficiency Virus (HIV)
  • Receipt of a live vaccine within 30 days of planned start of study therapy.
  • Breast implant on the side of the body that will receive HIFU application
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237572


Contacts
Contact: Jessica Zareno, MS 434-982-1901 jhz4f@virginia.edu
Contact: Alexandra Carney, MPH 434-982-6714 alc6a@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Jessica Zareno, MS    434-982-1901    jhz4f@virginia.edu   
Contact: Alexandra Carney, MPH    434-982-6714    alc6a@virginia.edu   
Sponsors and Collaborators
Patrick Dillon, MD
Investigators
Principal Investigator: Patrick Dillon, MD University of Virginia
  More Information

Responsible Party: Patrick Dillon, MD, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT03237572     History of Changes
Other Study ID Numbers: 19900
First Submitted: July 31, 2017
First Posted: August 2, 2017
Last Update Posted: September 26, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Patrick Dillon, MD, University of Virginia:
breast cancer
pembrolizumab
focused ultrasound
immunotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pembrolizumab
Antineoplastic Agents