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Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer

Primary Purpose

Invasive Ductal Carcinoma, Breast

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cryoablation
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invasive Ductal Carcinoma, Breast focused on measuring invasive ductal carcinoma, breast cancer, cryoablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Ultrasound visible invasive ductal carcinoma (IDC) diagnosed by core needle biopsy;
  • Tumor visible by ultrasound at time of treatment;
  • Unifocal primary disease;
  • Tumor size between 0.5 cm and 2.0 cm (as measured on ultrasound);
  • Tumor depth ≥ 0.5 cm from the skin or nipple-areola complex;
  • Planned lumpectomy

Exclusion Criteria:

  • Pregnant patients
  • Multifocal or metastatic disease
  • Planned neoadjuvant chemotherapy or radiation
  • Extensive ductal carcinoma in situ (DCIS; >25% DCIS component) either diagnosed on core biopsy or strongly suggested by imaging
  • Known allergy to both lidocaine and benzocaine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Cryoablation

    Control

    Arm Description

    Participants in this arm will receive cryoablation of their breast tumor two weeks before their routine lumpectomy. They will undergo two blood draws: one before cryoablation (at the time of consent) and one after cryoablation (at the time of surgery).

    Participants in this arm will undergo a blood draw at the time of consent and then will continue with their scheduled lumpectomy (standard of care).

    Outcomes

    Primary Outcome Measures

    Incidence of treatment-emergent adverse events [safety]
    Assessed via phone call with participant and including any participant-reported adverse events, such as pain, bruising, bleeding, swelling, and skin changes
    Immune response
    Immunohistochemical analysis of biomarkers in blood and resected tissue
    Cosmetic outcome
    Change in appearance based on distortion and volume loss of the breast
    Tumor margin status [effectiveness]
    Assessment of whether excised tumor's margins are positive or negative for cancer, and whether re-excision is required

    Secondary Outcome Measures

    Full Information

    First Posted
    April 5, 2018
    Last Updated
    August 19, 2019
    Sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03523299
    Brief Title
    Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer
    Official Title
    Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Principal investigator wishes to revisit design and start a new study
    Study Start Date
    May 22, 2018 (Actual)
    Primary Completion Date
    August 1, 2019 (Actual)
    Study Completion Date
    August 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study will investigate the safety, feasibility, and immune response associated with cryoablation of early invasive breast cancer prior to lumpectomy. Based on mouse models, the investigators believe that cryoablation will initiate a stronger immune response relative to the control group. Consenting patients will be randomized to one of two arms: standard of care (control) or cryoablation (intervention). Participants will undergo a blood draw at the time of consent. Those in the control arm will continue with their standard of care lumpectomy. The intervention arm will receive cryoablation 2 weeks before their scheduled lumpectomy and undergo a second blood draw before the lumpectomy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Invasive Ductal Carcinoma, Breast
    Keywords
    invasive ductal carcinoma, breast cancer, cryoablation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cryoablation
    Arm Type
    Experimental
    Arm Description
    Participants in this arm will receive cryoablation of their breast tumor two weeks before their routine lumpectomy. They will undergo two blood draws: one before cryoablation (at the time of consent) and one after cryoablation (at the time of surgery).
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Participants in this arm will undergo a blood draw at the time of consent and then will continue with their scheduled lumpectomy (standard of care).
    Intervention Type
    Procedure
    Intervention Name(s)
    Cryoablation
    Other Intervention Name(s)
    cryosurgery, cryotherapy
    Intervention Description
    Cryoablation is a non-surgical, minimally invasive freezing procedure used to destroy tumors. In the breast, cryoablation is performed under ultrasound guidance. Due to the analgesic properties of freezing, no IV sedation or anesthesia is required. After administration of local anesthetic, the physician makes a 2-3 mm incision and inserts needle-like cryoprobes into the tumor, commencing a number of freeze-thaw cycles. Then the probe is removed, pressure is applied to the area, and a bandage is placed. The patient leaves the office without stitches and minimal, if any, pain. Any residual pain after the procedure is routinely treated with over the counter analgesics such as acetaminophen.
    Primary Outcome Measure Information:
    Title
    Incidence of treatment-emergent adverse events [safety]
    Description
    Assessed via phone call with participant and including any participant-reported adverse events, such as pain, bruising, bleeding, swelling, and skin changes
    Time Frame
    1 day after cryoablation
    Title
    Immune response
    Description
    Immunohistochemical analysis of biomarkers in blood and resected tissue
    Time Frame
    One week after lumpectomy
    Title
    Cosmetic outcome
    Description
    Change in appearance based on distortion and volume loss of the breast
    Time Frame
    Change from one month to one year after lumpectomy
    Title
    Tumor margin status [effectiveness]
    Description
    Assessment of whether excised tumor's margins are positive or negative for cancer, and whether re-excision is required
    Time Frame
    7-10 days after lumpectomy

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ultrasound visible invasive ductal carcinoma (IDC) diagnosed by core needle biopsy; Tumor visible by ultrasound at time of treatment; Unifocal primary disease; Tumor size between 0.5 cm and 2.0 cm (as measured on ultrasound); Tumor depth ≥ 0.5 cm from the skin or nipple-areola complex; Planned lumpectomy Exclusion Criteria: Pregnant patients Multifocal or metastatic disease Planned neoadjuvant chemotherapy or radiation Extensive ductal carcinoma in situ (DCIS; >25% DCIS component) either diagnosed on core biopsy or strongly suggested by imaging Known allergy to both lidocaine and benzocaine
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cesar Santa-Maria, MD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer

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