Trial Outcomes & Findings for Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast (NCT NCT00003404)

NCT ID: NCT00003404

Last Updated: 2019-01-22

Results Overview

Local recurrence rate of phyllodes tumors

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 46 participants
• Primary outcome timeframe: 36 months after initial excision
• Results posted on: 2019-01-22

Participant Flow

Patients were enrolled from a total of 30 different institutions. Half of the patients were treated at community-based treatment centers, and half were treated at academic medical centers.

Participant milestones

Measure	Adjuvant Radiotherapy Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.
Overall Study STARTED	46
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast

Baseline characteristics by cohort

Measure	Adjuvant Radiotherapy n=46 Participants Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.
Age, Continuous	49 years n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months after initial excision

Local recurrence rate of phyllodes tumors

Outcome measures

Measure	Adjuvant Radiotherapy n=46 Participants Adjuvant radiation was started within 12 weeks of local excision or breast re-excision. Adjuvant Radiotherapy: Adjuvant radiation therapy
Local Recurrence Rate	0 Participants

SECONDARY outcome

Timeframe: Approximately 5 years

Population: All patients received adjuvant radiotherapy as specified in the protocol. No patients were lost to follow-up. Duration of follow-up ranged from 12 to 129 months, with a median follow-up of 56 months and a mean follow-up of 60 months. Ninety percent of the patients were followed for at least 2 years.

Survival will be tracked for 10 years after initial resection of first participant treated.

Outcome measures

Measure	Adjuvant Radiotherapy n=46 Participants Adjuvant radiation was started within 12 weeks of local excision or breast re-excision. Adjuvant Radiotherapy: Adjuvant radiation therapy
Survival Rate	2 Participants

Adverse Events

Adjuvant Radiotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard J. Barth Jr., MD

Dartmouth Hitchcock Medical Center

Phone: (603) 650-9479

Email: Richard.J.Barth.Jr@hitchcock.org

Results disclosure agreements

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