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

A study testing Survey in people with Breast Cancer, run by Dana-Farber Cancer Institute at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

This research study is evaluating how patients feel physically and emotionally after a prior breast biopsy for specific breast conditions (including atypical lesions such as atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ (LCIS), and/or ductal carcinoma in situ (DCIS)) Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: Survey
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 912 participants
Where: 6 sitesUnited States
Study dates: 1 Dec 2017to 25 Feb 2030
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients treated at DUMC, DFCI, MDACC, MGH, NWH, or DFCI @ SSH with a diagnosis of DCIS, LCIS, ADH, or ALH who are also:
Age 18 or more at index diagnosis
Diagnosed with DCIS, LCIS, ADH, or ALH between January 1, 2012 and June 30, 2017
Able to read either English or Spanish and able to provide written (via paper), or on-line informed consent
Treated and followed at one of the study sites (including affiliated network sites) and for whom treatment and surveillance data are available, for at least 1 year of follow up after date of diagnosis
Participants with bilateral synchronous or metachronous disease (DCIS, LCIS, ADH, ALH) are eligible

Who cannot join

Ever had a diagnosis of invasive or microinvasive breast cancer
DCIS prior to index lesion or history of progressive/recurrent DCIS after treatment
Other cancers (excluding non-melanoma skin cancer) diagnosed within 5 years prior to index lesion, including concurrent invasive cancer diagnosis and up to the present time of participant's approach to invitation into the study
Patients identified by treating physician as being unsuitable for contact

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Duke University Medical Center
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital
Weymouth, Massachusetts, 02198

Other trials in United States

About this study

Read the detailed description

The goal of this research is to better understand the experience of women who have been diagnosed with certain breast conditions to enable women (and their doctors) to make informed decisions about their care.

Conditions: Breast Cancer
Being tested: Survey
Keywords: Breast Cancer
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SurveyOther
Select questions will be ask in the survey

Study groups in NCT03070236
Study group	Role	What they receive
Patient-reported Outcomes Survey	Experimental	The survey will administered online, over the phone, or via mail. Receives: Other: Survey

What is being measured

The primary outcome is the main question the study is designed to answer.

The Primary Outcome Measures Severity of Chronic Pain.
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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201725 Feb 2030

First posted3 Mar 2017
Study start1 Dec 2017
Primary completion27 May 2019
Study completion25 Feb 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 912 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03070236
Sponsor's protocol ID: 16-571
Status last verified: Jan 2026
First submitted: 16 Feb 2017
Last updated: 3 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PORTAL: Patient-reported Outcomes After Routine Treatment of Atypical Lesions
ClinicalTrials.gov ID: NCT03070236
Acronym / sponsor ID: 16-571
Conditions: Breast Cancer
Keywords: Breast Cancer
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 912 participants (actual)
Lead sponsor: Dana-Farber Cancer InstituteUniversity, hospital or other
Study start: 1 Dec 2017 (actual)
Primary completion: 27 May 2019 (actual)
Study completion: 25 Feb 2030 (estimated)
First posted: 3 Mar 2017 (actual)
Results: Posted 9 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patient-reported Outcomes Survey	Experimental	Other: SurveyThe survey will administered online, over the phone, or via mail.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients treated at DUMC, DFCI, MDACC, MGH, NWH, or DFCI @ SSH with a diagnosis of DCIS, LCIS, ADH, or ALH who are also:
Age 18 or more at index diagnosis
Diagnosed with DCIS, LCIS, ADH, or ALH between January 1, 2012 and June 30, 2017
Able to read either English or Spanish and able to provide written (via paper), or on-line informed consent
Treated and followed at one of the study sites (including affiliated network sites) and for whom treatment and surveillance data are available, for at least 1 year of follow up after date of diagnosis

Key exclusion criteria (4 listed)

Ever had a diagnosis of invasive or microinvasive breast cancer
DCIS prior to index lesion or history of progressive/recurrent DCIS after treatment
Other cancers (excluding non-melanoma skin cancer) diagnosed within 5 years prior to index lesion, including concurrent invasive cancer diagnosis and up to the present time of participant's approach to invitation into the study
Patients identified by treating physician as being unsuitable for contact

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SurveySelect questions will be ask in the survey	Other	Patient-reported Outcomes Survey

Primary outcome

The Primary Outcome Measures Severity of Chronic Pain.
Time frame: 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.
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.

Results and safety

Results posted to the registry on 9 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Guideline Concordant Care (GCC) & Active Surveillance (AS)	912	912

Primary outcome: The Primary Outcome Measures Severity of Chronic Pain.

Time frame: 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.. Mean (Full Range). Unit: Composite Score

Measure	Guideline Concordant Care (GCC) n = 538	Active Surveillance (AS) n = 374
Value	6.4 (0.0 to 80.0)	3.0 (0.0 to 64.0)

Adverse events

Time frame: Approximately 19 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Guideline Concordant Care (GCC) & Active Surveillance (AS)	0 of 912 (0%)	0 of 912 (0%)	0 of 912

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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RecruitingPhase 2
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Not yet recruitingObservational study
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RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ann H. Partridge, MD, MPH study director

Dana-Farber Cancer Institute

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Survey in people with Breast Cancer, run by Dana-Farber Cancer Institute at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Primary Outcome Measures Severity of Chronic Pain. (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03070236.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.