Trial Outcomes & Findings for Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer (NCT NCT00723294)

Last Updated: 2017-08-14

Results Overview

The primary endpoint for this study is the rate of complete ablation. Complete ablation is defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion. The rate (percentage) will be computed as the number of patient lesions with complete tumor ablation divided by the total number of eligible patient lesions. This rate will be estimated by the binomial point estimate (number of patients with no pathological evidence of residual disease in the targeted lesion after ablation divided by the number of eligible patients) and a one-sided 90% binomial confidence interval (interval with a lower bound).

Recruitment status

UNKNOWN

Study phase

PHASE2

Target enrollment

99 participants

Primary outcome timeframe

Up to 14 days post surgery

Results posted on

2017-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Cryoablation) A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
Overall Study STARTED	99
Overall Study COMPLETED	86
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Cryoablation) A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
Overall Study Lobular histology	2
Overall Study >25% intraductal component	1
Overall Study No MRI tumor enhancement	1
Overall Study 1.0-Tesla MRI	1
Overall Study No cryoabalation	2
Overall Study Did not undergo surgery	1
Overall Study Treated prior to registration	1
Overall Study Treated by non-credentialed surgeon	1
Overall Study Benign lesion	1
Overall Study Withdrawal by Subject	1
Overall Study No treatment due to probe failure	1

Baseline Characteristics

Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Cryoablation) n=86 Participants A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	86 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 14 days post surgery

Population: One patient had bilateral disease and therefore outcomes are reported for 87 lesions.

Outcome measures

Outcome measures
Measure	Treatment (Cryoablation) n=87 lesions A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
Rate of Complete Tumor Ablation	75.9 percentage of lesions Interval 67.1 to 83.2

SECONDARY outcome

Timeframe: Up to 14 days post cryoablation

Population: One patient had bilateral disease and therefore outcomes are reported for 87 cancers.

Negative predictive value of MRI: The negative predictive rate of MRI will be estimated as the number of patients with no residual disease upon pathologic review of the resected tissue AND with a MRI that indicated no residual disease divided by the number of patients who had an MRI that indicated no residual disease. Both a binomial point estimate and 90% two-sided confidence interval will be computed.

Outcome measures

Outcome measures
Measure	Treatment (Cryoablation) n=87 cancers A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
Negative Predictive Value of MRI	81.2 percentage of cancers Interval 71.4 to 88.8

SECONDARY outcome

Timeframe: Up to 14 days post surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 14 days post surgery

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Cryoablation)

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Cryoablation) n=90 participants at risk A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
Blood and lymphatic system disorders Lymphatic disorder	2.2% 2/90 • Number of events 2 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
Gastrointestinal disorders Nausea	4.4% 4/90 • Number of events 4 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
General disorders Injection site reaction	1.1% 1/90 • Number of events 1 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
General disorders Localized edema	6.7% 6/90 • Number of events 7 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
General disorders Pain	1.1% 1/90 • Number of events 1 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
Infections and infestations Wound infection	2.2% 2/90 • Number of events 2 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
Injury, poisoning and procedural complications Bruising	36.7% 33/90 • Number of events 47 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
Injury, poisoning and procedural complications Intraoperative breast injury	1.1% 1/90 • Number of events 2 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
Injury, poisoning and procedural complications Seroma	8.9% 8/90 • Number of events 8 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
Musculoskeletal and connective tissue disorders Myositis	1.1% 1/90 • Number of events 1 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
Nervous system disorders Dizziness	1.1% 1/90 • Number of events 2 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
Nervous system disorders Headache	3.3% 3/90 • Number of events 3 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
Nervous system disorders Peripheral sensory neuropathy	1.1% 1/90 • Number of events 1 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
Reproductive system and breast disorders Breast pain	35.6% 32/90 • Number of events 45 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
Reproductive system and breast disorders Nipple deformity	4.4% 4/90 • Number of events 5 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
Skin and subcutaneous tissue disorders Pruritus	1.1% 1/90 • Number of events 1 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.
Vascular disorders Hematoma	1.1% 1/90 • Number of events 1 • Adverse events are assessed 14 to 28 days post-cryoablation and within 14 days post surgery. Toxicities/adverse events must be described and graded using the terminology and grading categories defined in the most current version of the NCI's Common Toxicity Criteria (CTCAE) version 3.0. NOTE: CTCAE Version 3 will continue to be used for determining dose modifications/delays and for routine adverse event reporting. Effective October 1, 2010, CTCAE Version 4 will be used for expedited adverse event reporting only.

Additional Information

Rache M. Simmons, MD

Weill Cornell Medicine

Phone: (212) 821-0870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place