Trial Outcomes & Findings for Cryoablation for Invasive Breast Carcinoma Following Neoadjuvant Therapy (NCT NCT01388777)

Last Updated: 2018-07-17

Results Overview

The rate of complete tumor ablation in the target lesion will be evaluated by pathologic review of the surgical specimen.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

From cryoablation through 30 days from surgery

Results posted on

2018-07-17

Participant Flow

Ten participants are required for analysis. Patients over 18, with invasive ductal carcinoma with less than or equal to 2 cm residual disease after neoadjuvant treatment, among other criteria are eligible.

Early termination leading to small number of subjects analyzed.

Participant milestones

Participant milestones
Measure	All Participants Enrolled and Started Treatment All participants will undergo imaging, cryoablation and further imaging, then surgery.
Overall Study STARTED	1
Overall Study Cryoablation	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cryoablation for Invasive Breast Carcinoma Following Neoadjuvant Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants Enrolled and Started Treatment n=1 Participants All participants will undergo imaging, cryoablation and further imaging, then surgery.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From cryoablation through 30 days from surgery

The rate of complete tumor ablation in the target lesion will be evaluated by pathologic review of the surgical specimen.

Outcome measures

Outcome measures
Measure	All Participants Enrolled and Started Treatment n=1 Participants All participants will undergo imaging, cryoablation and further imaging, then surgery.
Rate of Complete Tumor Ablation	0 Participants

Adverse Events

All Participants Enrolled and Started Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hwang, Rosa, M.D.

UT MD Anderson Cancer Center

Phone: 713-792-7734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place