Cryoablation vs Lumpectomy in T1 Breast Cancers

Conditions

• Breast Cancer
• Breast Neoplasm

Eligibility Criteria

Sex

FEMALE

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Endocare SlimLine Cryoprobe — DEVICE
  The Endocare(TM) SlimLine (TM) Cryoprobe is a single use, disposable device designed for use with Endocare Cryocare Surgical Systems. Endocare cryoprobes are designed to deliver cold temperatures for cryoablation using high-pressure argon gas circulated through the cryoprobe, followed by active thawing using helium gas. The Cryocare CS Surgical System is intended for use in open, minimally invasive, or endoscopic surgical procedures in the areas of general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery, and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures.
• Lumpectomy — PROCEDURE
  Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.

Study Details

This trial studies the efficacy and safety of cryoablation in patients with low risk, early stage breast cancer. Cryoablation is a method of killing a tumor by freezing it. The standard approach for patients with this kind of cancer is a lumpectomy. This study will review the safety of the cryoablation procedure initially, followed by comparing cryoablation to lumpectomy in order to see if the cryoablation results in better disease control, complication rates, and quality of life.

Key Dates

Start date

Apr 3, 2024

Status verified

Feb 2026

Primary completion

Apr 30, 2033

Completion

Apr 30, 2033

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cryoablation
  Patients will be treated with cryoablation using the Endocare SlimLine Cyroprobe under real time ultrasound guidance and local anesthesia. The cryoablation consists of a 10 minute freeze phase followed by a 10 minute passive thaw, and ends with a second 10 minute freeze cycle. The freeze-thaw-freeze times may be adjusted at the physician's discretion depending on tumor size.
• Active Comparator: Lumpectomy
  Lumpectomy will be performed under general anesthesia as per standard operative procedures at Washington University and Siteman Cancer Center.
• Other: Rescue Arm: Lumpectomy
  If there is evidence of residual or recurrent tumor on follow-up imaging evaluation (6 month MRI (if can tolerate) and yearly MRI/mammography), patients in the cryoablation safety lead-in and who were randomized to receive cryoablation only will be crossed over to receive a rescue lumpectomy followed by adjuvant treatment based on standard of care.
• Experimental: Cryoablation - Safety Lead In
  Patients will be treated with cryoablation (Day 1) using the Endocare SlimLine Cyroprobe followed by adjuvant treatment.

Primary Outcome Measure

Safety Lead-In: Number of treatment-related complications [ Time Frame: Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days) ]

Central Contacts

• Heather Garrett, M.D.
  636-916-9662
  [email protected]

Locations (1)

Find similar trials in St Louis, MO

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