Trial Outcomes & Findings for PORTAL: Patient-reported Outcomes After Routine Treatment of Atypical Lesions (NCT NCT03070236)

Last Updated: 2026-02-03

Results Overview

The Breast Cancer Pain Questionnaire (BCPQ) is a validated, self-reported instrument assessing pain severity, pain frequency (how many days per week), and pain location (breast, arm, side, axilla) over the last 2-week period with an average of 45.8 months from treatment for the two groups, Guideline Concordant Care (GCC) and Active Surveillance (AS). The Pain Burden Index (PBI) is a composite of pain severity, pain frequency, and pain location. Each severity answer is multiplied by each frequency answer and then summed with a total possible score ranging from 0-200 with higher scores indicating worse pain.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

912 participants

Primary outcome timeframe

Patient reported outcome was scheduled from at least one year from diagnosis. Participants' time from diagnosis to completing a survey was an average of 45.8 months in this study cohort.

Results posted on

2026-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Guideline Concordant Care (GCC) & Active Surveillance (AS) Guideline Concordant Care (GCC): Women who receive a combination of surgery, radiation and hormonal therapy - treatments similar to those recommended to patients with invasive cancer. Active Surveillance (AS): Women who receive a treatment strategy, under study for management of low-risk DCIS, that does not include surgery or radiation.
Overall Study STARTED	912
Overall Study Guideline Concordant Care (GCC) arm	538
Overall Study Active Surveillance (AS) arm	374
Overall Study COMPLETED	912
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PORTAL: Patient-reported Outcomes After Routine Treatment of Atypical Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Guideline Concordant Care (GCC) n=538 Participants Women who receive a combination of surgery, radiation and hormonal therapy - treatments similar to those recommended to patients with invasive cancer.	Active Surveillance (AS) n=374 Participants Women who receive a treatment strategy, under study for management of low-risk DCIS, that does not include surgery or radiation.	Total n=912 Participants Total of all reporting groups
Age, Continuous	60.7 years n=13 Participants	58.4 years n=15 Participants	59.8 years n=28 Participants
Sex: Female, Male Female	538 Participants n=13 Participants	374 Participants n=15 Participants	912 Participants n=28 Participants
Sex: Female, Male Male	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	31 Participants n=13 Participants	19 Participants n=15 Participants	50 Participants n=28 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	503 Participants n=13 Participants	350 Participants n=15 Participants	853 Participants n=28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=13 Participants	5 Participants n=15 Participants	9 Participants n=28 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Asian	22 Participants n=13 Participants	20 Participants n=15 Participants	42 Participants n=28 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Black or African American	40 Participants n=13 Participants	15 Participants n=15 Participants	55 Participants n=28 Participants
Race (NIH/OMB) White	459 Participants n=13 Participants	330 Participants n=15 Participants	789 Participants n=28 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=13 Participants	9 Participants n=15 Participants	26 Participants n=28 Participants
Region of Enrollment United States	538 participants n=13 Participants	374 participants n=15 Participants	912 participants n=28 Participants

PRIMARY outcome

Timeframe: Patient reported outcome was scheduled from at least one year from diagnosis. Participants' time from diagnosis to completing a survey was an average of 45.8 months in this study cohort.

Outcome measures

Outcome measures
Measure	Guideline Concordant Care (GCC) n=538 Participants Women who receive a combination of surgery, radiation and hormonal therapy - treatments similar to those recommended to patients with invasive cancer.	Active Surveillance (AS) n=374 Participants Women who receive a treatment strategy, under study for management of low-risk DCIS, that does not include surgery or radiation.
The Primary Outcome Measures Severity of Chronic Pain.	6.4 Composite Score Interval 0.0 to 80.0	3.0 Composite Score Interval 0.0 to 64.0

Adverse Events

Guideline Concordant Care (GCC) & Active Surveillance (AS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ann H. Partridge, MD, MPH

Dana-Farber Cancer Institute (DFCI)

Phone: 617-632-3800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place