Trial Outcomes & Findings for CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI) (NCT NCT02365714)

Last Updated: 2018-04-13

Results Overview

Only one of two patients were able to undergo CyberKnife SAPBI. We are measuring the percentage of enrolled subjects in whom CyberKnife SAPBI PBI is technically feasible to deliver and complete treatment

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Enrollment to 24 months

Results posted on

2018-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	CyberKnife Arm This is a single arm study for patients who are eligible for partial breast irradiation.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CyberKnife Arm n=2 Participants Two patients were enrolled for CyberKnife. In one patient, the fiducials were unable to be tracked, so she received external beam partial breast irradiation.
Age, Continuous	59 years n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	2 Participants n=93 Participants

PRIMARY outcome

Timeframe: Enrollment to 24 months

Outcome measures

Outcome measures
Measure	CyberKnife Arm n=2 Participants This is a single arm study for patients who are eligible for partial breast irradiation.
The Primary Endpoint for This Study is the Percentage of Enrolled Subjects in Whom CyberKnife SAPBI PBI is Technically Feasible to Deliver and Complete Treatment	2 Participants

PRIMARY outcome

Timeframe: 2 years

How many patients were able to undergo CK SAPBI

Outcome measures

Outcome measures
Measure	CyberKnife Arm n=2 Participants This is a single arm study for patients who are eligible for partial breast irradiation.
Feasibility	1 Participants

SECONDARY outcome

Timeframe: 1 month post radiation treatment through 5 years post treatment

No patients have recurred to date.

Outcome measures

Outcome measures
Measure	CyberKnife Arm n=2 Participants This is a single arm study for patients who are eligible for partial breast irradiation.
Ipsilateral Breast Recurrence	0 Participants

Adverse Events

Treatment-Radiation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment-Radiation n=2 participants at risk CyberKnife (CK) Stereotactic Accelerated Partial Breast Irradiation. Adjuvant radiation therapy delivered to the region around the lumpectomy cavity. Patients will receive 30 Gy in 5 fractions over 5-14 days. CK Stereotactic Accelerated Partial Breast Irradiation: Adjuvant radiation therapy will be delivered to the region of the lumpectomy cavity once daily for 5 treatments over 5-10 days.
Skin and subcutaneous tissue disorders RT dermatitis	100.0% 2/2 • Number of events 2

Additional Information

Sonali Rudra, M.D.

Medstar Georgetown University Hospital

Phone: 202-444-3320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place