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Trial Outcomes & Findings for Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer (NCT NCT03137693)

NCT ID: NCT03137693

Last Updated: 2023-02-23

Results Overview

Rate of pathologic complete response following pre-operative SABR for early-stage breast carcinoma. pCR: The absence of residual invasive disease in the breast and in the axillary lymph nodes at the completion of the neoadjuvant treatment.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

6 weeks post SABR

Results posted on

2023-02-23

Participant Flow

Participant milestones

Participant milestones
Measure
All Participants
All participants who received Stereotactic Ablative Body Radiotherapy (SABR) prior to breast surgery
Overall Study
STARTED
20
Overall Study
COMPLETED
20
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=20 Participants
All participants who received Stereotactic Ablative Body Radiotherapy (SABR) prior to breast surgery
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
n=5 Participants
Age, Categorical
>=65 years
11 Participants
n=5 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 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
0 Participants
n=5 Participants
Race (NIH/OMB)
White
19 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
20 participants
n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks post SABR

Rate of pathologic complete response following pre-operative SABR for early-stage breast carcinoma. pCR: The absence of residual invasive disease in the breast and in the axillary lymph nodes at the completion of the neoadjuvant treatment.

Outcome measures

Outcome measures
Measure
All Participants
n=20 Participants
All participants who received Stereotactic Ablative Body Radiotherapy (SABR) prior to breast surgery
Rate of Pathologic Complete Response (pCR)
0 percentage of participants

Adverse Events

All Participants

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
All Participants
n=20 participants at risk
All participants who received Stereotactic Ablative Body Radiotherapy (SABR) prior to breast surgery
Injury, poisoning and procedural complications
Dermatitis radiation
5.0%
1/20 • Number of events 1 • 1 year, 11 months
General disorders
Pain
10.0%
2/20 • Number of events 2 • 1 year, 11 months
Infections and infestations
Infections and Infestations - Other
5.0%
1/20 • Number of events 1 • 1 year, 11 months

Additional Information

Michael Montejo, MD

Moffitt Cancer Center

Phone: 813-745-8424

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place