Trial Outcomes & Findings for Phyllodes Tumor Partial Breast Radiation Study (NCT NCT01089374)

Last Updated: 2023-07-25

Results Overview

The primary objective is to determine the local recurrence rate for patients with borderline or malignant phyllodes tumors treated with breast conserving resection with negative margins and adjuvant partial breast radiation therapy. Recurrence rate is measured by occurrence of biopsy proven recurrences during follow up, up to 10 years following patient enrollment.

Recruitment status

TERMINATED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

up to 10 years

Results posted on

2023-07-25

Participant Flow

Historical controls were not enrolled as part of this study. Information regarding the historical controls can be found under NCT00003404.

Participant milestones

Participant milestones
Measure	Partial Breast Radiation After Lumpectomy Radiation per NSABP B-39/R0413 protocol. Partial breast radiation after lumpectomy: Radiation therapy will be administered in the vicinity of the center where the surgical resection was performed. Adjuvant radiation must start within 12 weeks of breast excision or re-excision. The radiation oncologist can choose between two methods of partial breast irradiation (PBI): external beam partial breast radiation or Mammosite® brachytherapy, based on radiation oncologist and patient preference. Radiation will be administered per guidelines used in the NSABP B-39/RTOG 0413 protocol.	Historical Control Historical controls treated with whole breast radiation therapy after breast conserving resection with negative margins. Information regarding the historical controls can be found under NCT00003404.
Overall Study STARTED	11	46
Overall Study COMPLETED	1	46
Overall Study NOT COMPLETED	10	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Partial Breast Radiation After Lumpectomy Radiation per NSABP B-39/R0413 protocol. Partial breast radiation after lumpectomy: Radiation therapy will be administered in the vicinity of the center where the surgical resection was performed. Adjuvant radiation must start within 12 weeks of breast excision or re-excision. The radiation oncologist can choose between two methods of partial breast irradiation (PBI): external beam partial breast radiation or Mammosite® brachytherapy, based on radiation oncologist and patient preference. Radiation will be administered per guidelines used in the NSABP B-39/RTOG 0413 protocol.	Historical Control Historical controls treated with whole breast radiation therapy after breast conserving resection with negative margins. Information regarding the historical controls can be found under NCT00003404.
Overall Study Lost to Follow-up	3	0
Overall Study Withdrawal by Subject	1	0
Overall Study Study closed early - low accrual	6	0

Baseline Characteristics

Phyllodes Tumor Partial Breast Radiation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Partial Breast Radiation After Lumpectomy n=11 Participants Radiation per NSABP B-39/R0413 protocol. Partial breast radiation after lumpectomy: Radiation therapy will be administered in the vicinity of the center where the surgical resection was performed. Adjuvant radiation must start within 12 weeks of breast excision or re-excision. The radiation oncologist can choose between two methods of partial breast irradiation (PBI): external beam partial breast radiation or Mammosite® brachytherapy, based on radiation oncologist and patient preference. Radiation will be administered per guidelines used in the NSABP B-39/RTOG 0413 protocol.	Historical Control n=46 Participants Historical controls treated with whole breast radiation therapy after breast conserving resection with negative margins	Total n=57 Participants Total of all reporting groups
Age, Continuous	46 years n=5 Participants	49 years n=7 Participants	47.5 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	46 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	46 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	0 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	46 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	46 participants n=7 Participants	57 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 10 years

Population: The following participants did not complete 10 years of follow up and were followed until the time points listed below: 1. participant lost to follow up after 6 months 2. participants lost to follow up after 1 year 1 participant withdrew after 9 years 6 participants remained on study until early study closure they were at the following time points at closure: 2 participants 4.5 years 1 participant 5 years 1 participant 6 years 1 participant 8 years 1 participant 9 years

Outcome measures

Outcome measures
Measure	Partial Breast Radiation After Lumpectomy n=11 Participants Radiation per NSABP B-39/R0413 protocol. Partial breast radiation after lumpectomy: Radiation therapy will be administered in the vicinity of the center where the surgical resection was performed. Adjuvant radiation must start within 12 weeks of breast excision or re-excision. The radiation oncologist can choose between two methods of partial breast irradiation (PBI): external beam partial breast radiation or Mammosite® brachytherapy, based on radiation oncologist and patient preference. Radiation will be administered per guidelines used in the NSABP B-39/RTOG 0413 protocol.	Historical Controls Historical controls treated with whole breast radiation therapy after breast conserving resection with negative margins.
Rate of Participants With Local Recurrence up to 10 Years	0 Participants	—

SECONDARY outcome

Timeframe: up to 10 years

Population: The following participants did not complete 10 years of follow up and were followed until the time points listed below: 1. participant lost to follow up after 6 months 2. participants lost to follow up after 1 year 1 participant withdrew after 9 years 6 participants remained on study until early study closure they were at the following time points at closure 2 participants 4.5 years 1 participant 5 years 1 participant 6 years 1 participant 8 years 1 participant 9 years

The secondary objective is to compare the local recurrence rate observed after partial breast radiation therapy with that observed in historical controls treated with whole breast radiation therapy after breast conserving resection with negative margins. This is measured by occurrence of biopsy proven recurrence up to 10 years after participant enrollment.

Outcome measures

Outcome measures
Measure	Partial Breast Radiation After Lumpectomy n=11 Participants Radiation per NSABP B-39/R0413 protocol. Partial breast radiation after lumpectomy: Radiation therapy will be administered in the vicinity of the center where the surgical resection was performed. Adjuvant radiation must start within 12 weeks of breast excision or re-excision. The radiation oncologist can choose between two methods of partial breast irradiation (PBI): external beam partial breast radiation or Mammosite® brachytherapy, based on radiation oncologist and patient preference. Radiation will be administered per guidelines used in the NSABP B-39/RTOG 0413 protocol.	Historical Controls n=46 Participants Historical controls treated with whole breast radiation therapy after breast conserving resection with negative margins.
Rate of Participants With Local Recurrence After Radiation Compared to Historic Controls	0 Participants	0 Participants

Adverse Events

Partial Breast Radiation After Lumpectomy

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	Partial Breast Radiation After Lumpectomy n=11 participants at risk Radiation per NSABP B-39/R0413 protocol. Partial breast radiation after lumpectomy: Radiation therapy will be administered in the vicinity of the center where the surgical resection was performed. Adjuvant radiation must start within 12 weeks of breast excision or re-excision. The radiation oncologist can choose between two methods of partial breast irradiation (PBI): external beam partial breast radiation or Mammosite® brachytherapy, based on radiation oncologist and patient preference. Radiation will be administered per guidelines used in the NSABP B-39/RTOG 0413 protocol.
Skin and subcutaneous tissue disorders Erythema	9.1% 1/11 • Number of events 1 • All patients will be encouraged to perform monthly breast self examination and will be followed with physical exams of the affected breast by their surgeon or radiation oncologist. These physical exams should occur every 6 months (+/- 3 months) after the initial resection through year 5 ( ie. at 6,12,18,24,30,36,42,48,54,and 60 months) and then every 12 months (+/- 3 months) years 5 through 10 (ie. 72, 84, 96,108 and 120 months). These physical exams should occur every 6 months (+/- 3 months) after the initial resection through year 5 ( ie. at 6,12,18,24,30,36,42,48,54,and 60 months) and then every 12 months (+/- 3 months) years 5 through 10 (ie. 72, 84, 96,108 and 120 months). Information relating to adverse events and serious adverse events for the historical controls can be found under NCT00003404.

Additional Information

Dr. Richard Barth

Dartmouth-Hitchcock Medical Center

Phone: 603-650-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place