Trial Outcomes & Findings for Electrochemotherapy for Chest Wall Recurrence af Breast Cancer: Present Challenges and Future Prospects. (NCT NCT00744653)

Results Overview

Response was evaluated clinical using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and documented with digital photography. Number of patients with objective response evaluated with clinical measure of lesion size

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

up to one year

Results posted on

2014-07-18

Participant Flow

recruitment period: October 2008 to November 2010. Total of 17 patients included and treated with electrochemotherapy.

Participant milestones

Participant milestones
Measure	Electrochemotherapy Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
Overall Study STARTED	17
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Electrochemotherapy Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
Overall Study antineoplastic treatment	11
Overall Study Death	1
Overall Study Lost to Follow-up	1
Overall Study Physician Decision	3

Baseline Characteristics

Electrochemotherapy for Chest Wall Recurrence af Breast Cancer: Present Challenges and Future Prospects.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electrochemotherapy n=17 Participants Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	58.6 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Denmark	17 participants n=5 Participants

PRIMARY outcome

Timeframe: up to one year

Population: Based on Simons optimal design for phase II trials, 25 evaluable patients were to be included and treated.

Response was evaluated clinical using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and documented with digital photography. Number of patients with objective response evaluated with clinical measure of lesion size

Outcome measures

Outcome measures
Measure	Electrochemotherapy n=12 Participants Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
Clinical Measure of Lesion Size.	2 Participants

SECONDARY outcome

Timeframe: 3, weeks, 8 weeks, and up to 6 months after treatment

Population: per protocol

Participants with objective response evaluated with PET/CT. Objective Response evaluated with CT and PET/CT.

Outcome measures

Outcome measures
Measure	Electrochemotherapy n=12 Participants Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
Participants With Objective Response Evaluated With PET/CT	4 participants

SECONDARY outcome

Timeframe: up to 1 year

Population: per protocol

Outcome measures

Outcome measures
Measure	Electrochemotherapy Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
Safety and Toxicity	0 adverse events

Adverse Events

Electrochemotherapy

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

MD Louise Wichmann Matthiessen

Copenhagen University Hospital Herlev

Phone: + 45 38 68 98 58

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place