Trial Outcomes & Findings for Study for Using Radiosurgery on Limited Metastases of Breast Cancer (NCT NCT00167414)

Results Overview

The percent of patients that survived from date of enrollment until 2 year follow-up visit.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

49 participants

Primary outcome timeframe

2 years

Results posted on

2018-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Hypofractionated Stereotactic Body Radiation Therapy Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary. Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.
Overall Study STARTED	49
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Hypofractionated Stereotactic Body Radiation Therapy Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary. Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.
Overall Study Death	10

Baseline Characteristics

Study for Using Radiosurgery on Limited Metastases of Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hypofractionated Stereotactic Body Radiation Therapy n=39 Participants Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary. Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.
Age, Continuous	53 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

The percent of patients that survived from date of enrollment until 2 year follow-up visit.

Outcome measures

Outcome measures
Measure	Hypofractionated Stereotactic Body Radiation Therapy n=39 Participants Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary. Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.
Overall Survival	74 percentage of participants

PRIMARY outcome

Timeframe: 4 years

The percent of patients that survived from date of enrollment until 4 year follow-up visit

Outcome measures

Outcome measures
Measure	Hypofractionated Stereotactic Body Radiation Therapy n=39 Participants Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary. Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.
Overall Survival	54 percentage of participants

PRIMARY outcome

Timeframe: 6 years

The percent of patients that survived from date of enrollment until 6 year follow-up visit

Outcome measures

Outcome measures
Measure	Hypofractionated Stereotactic Body Radiation Therapy n=39 Participants Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary. Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.
Overall Survival	47 percentage of participants

SECONDARY outcome

Timeframe: 6 years

Lesion local failure was scored as an event if any treated lesion increased by greater than or equal to 20% using the Response Evaluation Criteria in Solid Tumors criteria or local failure was confirmed pathologically. Lesion control includes all participants that did not fall into the category of lesion failure.

Outcome measures

Outcome measures
Measure	Hypofractionated Stereotactic Body Radiation Therapy n=39 Participants Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary. Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.
Percent of Patients With Lesion Local Control	87 percentage of participants

SECONDARY outcome

Timeframe: 6 years

Number of participants who experienced a grade 4 or 5 toxicity

Outcome measures

Outcome measures
Measure	Hypofractionated Stereotactic Body Radiation Therapy n=39 Participants Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary. Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.
Number of Participants Who Experienced a Grade 4 or 5 Toxicity	0 Participants

Adverse Events

Hypofractionated Stereotactic Body Radiation Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hypofractionated Stereotactic Body Radiation Therapy n=39 participants at risk Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary. Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) nonmalignant pleural and pericardial effusion	2.6% 1/39 • Number of events 1

Additional Information

Hong Zhang

University of Rochester

Phone: 585-341-6750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place