DCISNCT02248662
Impact of Radiation Therapy on Breast Conservation in DCIS
An observational study of DCIS, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial summary
Large regional variation exists in the use of radiotherapy after breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS). Although patients who do not receive initial radiotherapy for DCIS are candidates for subsequent BCS if they experience a second breast event, many undergo mastectomy instead. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- DCIS
- How many people
- 3,436 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2013to Jan 2017
- Phase
- Observational
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women identified from SEER and SEER-Medicare data with Stage 0-III breast cancer after DCIS who had received BCS without radiation for initial treatment.
This study used data from SEER and SEER-Medicare.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Harvard Pilgrim Health Care Institute
Boston, Massachusetts, 02215
Dartmouth College
Hanover, New Hampshire, 03755
University of Wisconsin
Madison, Wisconsin, 53792
About this study
Large regional variation exists in the use of radiotherapy after breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS). Although patients who do not receive initial radiotherapy for DCIS are candidates for subsequent BCS if they experience a second breast event, many undergo mastectomy instead.
Read the detailed description
Patients and their physicians are often confronted with a decision between more intensive versus less intensive treatment for a particular diagnosis. Quality decision-making between these options requires careful balancing of the risks and side-effects, as well as weighing the expected outcomes and their associated value as assessed by the patient.
Although the incidence of DCIS has risen dramatically (1), there exists considerable debate about optimal treatment. In general, people with DCIS have high rates of recurrence-free survival. Intensive therapies for DCIS such as mastectomy (removal of the breast) or radiation therapy following BCS reduce the likelihood of a second breast diagnosis,(2-5) but have not been shown to improve survival.(6) In addition, radiation usually necessitates mastectomy should a new cancer or DCIS develop in the same breast at any point during the patient's lifetime. Patients also have a small chance of experiencing long-term toxicity. Previous radiation can also complicate reconstructive options following mastectomy. The tradeoff between risk of second breast diagnosis and side-effects and potential consequences of radiation therapy underscores the need for patient preference-driven decision making.
Patients who receive BCS alone without radiation therapy may be candidates for repeat BCS if they have a second breast event in the same breast. One study suggests that some women choose not to have radiation after DCIS because they want to preserve a breast-preservation option should a second breast diagnosis occur.(7) However, the likelihood of mastectomy versus BCS at time of new diagnosis in a previously un-irradiated breast is variable.(8-10) Whether a woman receives repeat breast-conserving surgery for a new diagnosis may not only be a function of the stage of diagnosis, but may be also determined by the regional treatment patterns used for management of DCIS. We sought to study whether regional intensity of radiation use for DCIS treatment increases the likelihood of mastectomy at time of second breast event, among women who have not received radiation therapy at initial DCIS diagnosis. (Punglia RS, Cronin AM, Uno H, et al. Association of Regional Intensity of Ductal Carcinoma In Situ Treatment With Likelihood of Breast Preservation. JAMA Oncol. Published online July 21, 2016.)
- Conditions
- DCIS
- Keywords
- DCIS, PCORI, ductal carcinoma in situ, radiation, oncology, patient-centered, decision aid, decision-making
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surveillance, Epidemiology, and End Results (SEER) Database | Data were obtained for women in Surveillance, Epidemiology, and End Results (SEER) with a diagnosis of ductal carcinoma in situ (DCIS) between 1990 and 2011 who had not undergone radiotherapy for DCIS and experienced a subsequent breast cancer or DCIS diagnosis. | |
| Surveillance, Epidemiology, and End Results (SEER)-Medicare | Data were obtained for women in Surveillance, Epidemiology, and End Results (SEER)-Medicare with a ductal carcinoma in situ (DCIS) diagnosis between 1991 and 2009 who had not undergone radiotherapy for DCIS and experienced a subsequent breast cancer or DCIS diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Patient Characteristics and Three-Level Cluster of Treatment Intensity for Primary DCIS
The investigators defined treatment intensity in a health services area to be the proportion of patients undergoing breast conserving surgery for DCIS who receive radiation therapy. Because a proportion is challenging to analyze statistically given that the precision of the estimate depends on the size of the denominator which varies across service areas, we used hierarchical modeling to categorize the health service areas into three categories (low, medium, high), using a latent variable to determine which health service area belongs to each of the three categories. The cutoffs separating the groups were based on the hierarchical model, taking the precision of the estimated proportion of patients receiving radiation into account. Health service areas with the highest proportions of patients receiving radiation were assigned to the "high" cluster; those with the lowest proportions to the "low" cluster; and those in the between to the "medium" cluster.
Measured: 20 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startAug 2013
- Primary completionJan 2017
- Study completionJan 2017
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.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for DCISStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 3,436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Rinaa Punglia, MD MPH, Dana-Farber Cancer Institute
- Investigators
- Rinaa S. Punglia, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248662
- Sponsor's protocol ID
- 12-420
- Other IDs
- CE-12-11-4173
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2014
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sumner WE 3rd, Koniaris LG, Snell SE, Spector S, Powell J, Avisar E, Moffat F, Livingstone AS, Franceschi D. Results of 23,810 cases of ductal carcinoma-in-situ. Ann Surg Oncol. 2007 May;14(5):1638-43. doi: 10.1245/s10434-006-9316-1. Epub 2007 Jan 24.
PubMed 17245612Kim SY, Han BK, Kim EK, Choi WJ, Choi Y, Kim HH, Moon WK. Breast Cancer Detected at Screening US: Survival Rates and Clinical-Pathologic and Imaging Factors Associated with Recurrence. Radiology. 2017 Aug;284(2):354-364. doi: 10.1148/radiol.2017162348. Epub 2017 Apr 6.
PubMed 28387638EORTC Breast Cancer Cooperative Group; EORTC Radiotherapy Group; Bijker N, Meijnen P, Peterse JL, Bogaerts J, Van Hoorebeeck I, Julien JP, Gennaro M, Rouanet P, Avril A, Fentiman IS, Bartelink H, Rutgers EJ. Breast-conserving treatment with or without radiotherapy in ductal carcinoma-in-situ: ten-year results of European Organisation for Research and Treatment of Cancer randomized phase III trial 10853--a study by the EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group. J Clin Oncol. 2006 Jul 20;24(21):3381-7. doi: 10.1200/JCO.2006.06.1366. Epub 2006 Jun 26.
PubMed 16801628Fisher B, Land S, Mamounas E, Dignam J, Fisher ER, Wolmark N. Prevention of invasive breast cancer in women with ductal carcinoma in situ: an update of the National Surgical Adjuvant Breast and Bowel Project experience. Semin Oncol. 2001 Aug;28(4):400-18. doi: 10.1016/s0093-7754(01)90133-2.
PubMed 11498833Emdin SO, Granstrand B, Ringberg A, Sandelin K, Arnesson LG, Nordgren H, Anderson H, Garmo H, Holmberg L, Wallgren A; Swedish Breast Cancer Group. SweDCIS: Radiotherapy after sector resection for ductal carcinoma in situ of the breast. Results of a randomised trial in a population offered mammography screening. Acta Oncol. 2006;45(5):536-43. doi: 10.1080/02841860600681569.
PubMed 16864166Houghton J, George WD, Cuzick J, Duggan C, Fentiman IS, Spittle M; UK Coordinating Committee on Cancer Research; Ductal Carcinoma in situ Working Party; DCIS trialists in the UK, Australia, and New Zealand. Radiotherapy and tamoxifen in women with completely excised ductal carcinoma in situ of the breast in the UK, Australia, and New Zealand: randomised controlled trial. Lancet. 2003 Jul 12;362(9378):95-102. doi: 10.1016/s0140-6736(03)13859-7.
PubMed 12867108Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Correa C, McGale P, Taylor C, Wang Y, Clarke M, Davies C, Peto R, Bijker N, Solin L, Darby S. Overview of the randomized trials of radiotherapy in ductal carcinoma in situ of the breast. J Natl Cancer Inst Monogr. 2010;2010(41):162-77. doi: 10.1093/jncimonographs/lgq039.
PubMed 20956824Kaplan CP, Napoles AM, Hwang ES, Bloom J, Stewart S, Nickleach D, Karliner L. Selection of treatment among Latina and non-Latina white women with ductal carcinoma in situ. J Womens Health (Larchmt). 2011 Feb;20(2):215-23. doi: 10.1089/jwh.2010.1986. Epub 2010 Dec 3.
PubMed 21128819Fisher B, Dignam J, Wolmark N, Mamounas E, Costantino J, Poller W, Fisher ER, Wickerham DL, Deutsch M, Margolese R, Dimitrov N, Kavanah M. Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17. J Clin Oncol. 1998 Feb;16(2):441-52. doi: 10.1200/JCO.1998.16.2.441.
PubMed 9469327Fong J, Kurniawan ED, Rose AK, Mou A, Collins JP, Miller JA, Mann GB. Outcomes of screening-detected ductal carcinoma in situ treated with wide excision alone. Ann Surg Oncol. 2011 Dec;18(13):3778-84. doi: 10.1245/s10434-011-1748-6. Epub 2011 Jun 1.
PubMed 21630124Wong JS, Kaelin CM, Troyan SL, Gadd MA, Gelman R, Lester SC, Schnitt SJ, Sgroi DC, Silver BJ, Harris JR, Smith BL. Prospective study of wide excision alone for ductal carcinoma in situ of the breast. J Clin Oncol. 2006 Mar 1;24(7):1031-6. doi: 10.1200/JCO.2005.02.9975. Epub 2006 Feb 6.
PubMed 16461781Pickle LW, MungioleM, Jones GK, White AA. Atlas of United States Mortality. Hyattsville, MD: Centers for Disease Control and Prevention; December 1996. http://www.cdc.gov/nchs/data/misc/atlasmet.pdf. Accessed September 1, 2015.
Wennberg JE, Fisher ES, Skinner JS. Geography and the debate over Medicare reform. Health Aff (Millwood). 2002 Jul-Dec;Suppl Web Exclusives:W96-114. doi: 10.1377/hlthaff.w2.96.
PubMed 12703563Jagsi R, Abrahamse P, Hawley ST, Graff JJ, Hamilton AS, Katz SJ. Underascertainment of radiotherapy receipt in Surveillance, Epidemiology, and End Results registry data. Cancer. 2012 Jan 15;118(2):333-41. doi: 10.1002/cncr.26295. Epub 2011 Jun 29.
PubMed 21717446
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Radiation Therapy on Breast Conservation in DCIS
- ClinicalTrials.gov ID
- NCT02248662
- Acronym / sponsor ID
- 12-420
- Conditions
- DCIS
- Keywords
- DCIS, PCORI, ductal carcinoma in situ, radiation, oncology, patient-centered, decision aid, decision-making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,436 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Aug 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Large regional variation exists in the use of radiotherapy after breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS). Although patients who do not receive initial radiotherapy for DCIS are candidates for subsequent BCS if they experience a second breast event, many undergo mastectomy instead.
Detailed description
Patients and their physicians are often confronted with a decision between more intensive versus less intensive treatment for a particular diagnosis. Quality decision-making between these options requires careful balancing of the risks and side-effects, as well as weighing the expected outcomes and their associated value as assessed by the patient.
Although the incidence of DCIS has risen dramatically (1), there exists considerable debate about optimal treatment. In general, people with DCIS have high rates of recurrence-free survival. Intensive therapies for DCIS such as mastectomy (removal of the breast) or radiation therapy following BCS reduce the likelihood of a second breast diagnosis,(2-5) but have not been shown to improve survival.(6) In addition, radiation usually necessitates mastectomy should a new cancer or DCIS develop in the same breast at any point during the patient's lifetime. Patients also have a small chance of experiencing long-term toxicity. Previous radiation can also complicate reconstructive options following mastectomy. The tradeoff between risk of second breast diagnosis and side-effects and potential consequences of radiation therapy underscores the need for patient preference-driven decision making.
Patients who receive BCS alone without radiation therapy may be candidates for repeat BCS if they have a second breast event in the same breast. One study suggests that some women choose not to have radiation after DCIS because they want to preserve a breast-preservation option should a second breast diagnosis occur.(7) However, the likelihood of mastectomy versus BCS at time of new diagnosis in a previously un-irradiated breast is variable.(8-10) Whether a woman receives repeat breast-conserving surgery for a new diagnosis may not only be a function of the stage of diagnosis, but may be also determined by the regional treatment patterns used for management of DCIS. We sought to study whether regional intensity of radiation use for DCIS treatment increases the likelihood of mastectomy at time of second breast event, among women who have not received radiation therapy at initial DCIS diagnosis. (Punglia RS, Cronin AM, Uno H, et al. Association of Regional Intensity of Ductal Carcinoma In Situ Treatment With Likelihood of Breast Preservation. JAMA Oncol. Published online July 21, 2016.)
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surveillance, Epidemiology, and End Results (SEER) Database | – | –Data were obtained for women in Surveillance, Epidemiology, and End Results (SEER) with a diagnosis of ductal carcinoma in situ (DCIS) between 1990 and 2011 who had not undergone radiotherapy for DCIS and experienced a subsequent breast cancer or DCIS diagnosis. |
| Surveillance, Epidemiology, and End Results (SEER)-Medicare | – | –Data were obtained for women in Surveillance, Epidemiology, and End Results (SEER)-Medicare with a ductal carcinoma in situ (DCIS) diagnosis between 1991 and 2009 who had not undergone radiotherapy for DCIS and experienced a subsequent breast cancer or DCIS diagnosis. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women identified from SEER and SEER-Medicare data with Stage 0-III breast cancer after DCIS who had received BCS without radiation for initial treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association Between Patient Characteristics and Three-Level Cluster of Treatment Intensity for Primary DCIS
Time frame: 20 Years
The investigators defined treatment intensity in a health services area to be the proportion of patients undergoing breast conserving surgery for DCIS who receive radiation therapy. Because a proportion is challenging to analyze statistically given that the precision of the estimate depends on the size of the denominator which varies across service areas, we used hierarchical modeling to categorize the health service areas into three categories (low, medium, high), using a latent variable to determine which health service area belongs to each of the three categories. The cutoffs separating the groups were based on the hierarchical model, taking the precision of the estimated proportion of patients receiving radiation into account. Health service areas with the highest proportions of patients receiving radiation were assigned to the "high" cluster; those with the lowest proportions to the "low" cluster; and those in the between to the "medium" cluster.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17245612Sumner WE 3rd, Koniaris LG, Snell SE, Spector S, Powell J, Avisar E, Moffat F, Livingstone AS, Franceschi D. Results of 23,810 cases of ductal carcinoma-in-situ. Ann Surg Oncol. 2007 May;14(5):1638-43. doi: 10.1245/s10434-006-9316-1. Epub 2007 Jan 24.
- Background: PubMed 28387638Kim SY, Han BK, Kim EK, Choi WJ, Choi Y, Kim HH, Moon WK. Breast Cancer Detected at Screening US: Survival Rates and Clinical-Pathologic and Imaging Factors Associated with Recurrence. Radiology. 2017 Aug;284(2):354-364. doi: 10.1148/radiol.2017162348. Epub 2017 Apr 6.
- Background: PubMed 16801628EORTC Breast Cancer Cooperative Group; EORTC Radiotherapy Group; Bijker N, Meijnen P, Peterse JL, Bogaerts J, Van Hoorebeeck I, Julien JP, Gennaro M, Rouanet P, Avril A, Fentiman IS, Bartelink H, Rutgers EJ. Breast-conserving treatment with or without radiotherapy in ductal carcinoma-in-situ: ten-year results of European Organisation for Research and Treatment of Cancer randomized phase III trial 10853--a study by the EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group. J Clin Oncol. 2006 Jul 20;24(21):3381-7. doi: 10.1200/JCO.2006.06.1366. Epub 2006 Jun 26.
- Background: PubMed 11498833Fisher B, Land S, Mamounas E, Dignam J, Fisher ER, Wolmark N. Prevention of invasive breast cancer in women with ductal carcinoma in situ: an update of the National Surgical Adjuvant Breast and Bowel Project experience. Semin Oncol. 2001 Aug;28(4):400-18. doi: 10.1016/s0093-7754(01)90133-2.
- Background: PubMed 16864166Emdin SO, Granstrand B, Ringberg A, Sandelin K, Arnesson LG, Nordgren H, Anderson H, Garmo H, Holmberg L, Wallgren A; Swedish Breast Cancer Group. SweDCIS: Radiotherapy after sector resection for ductal carcinoma in situ of the breast. Results of a randomised trial in a population offered mammography screening. Acta Oncol. 2006;45(5):536-43. doi: 10.1080/02841860600681569.
- Background: PubMed 12867108Houghton J, George WD, Cuzick J, Duggan C, Fentiman IS, Spittle M; UK Coordinating Committee on Cancer Research; Ductal Carcinoma in situ Working Party; DCIS trialists in the UK, Australia, and New Zealand. Radiotherapy and tamoxifen in women with completely excised ductal carcinoma in situ of the breast in the UK, Australia, and New Zealand: randomised controlled trial. Lancet. 2003 Jul 12;362(9378):95-102. doi: 10.1016/s0140-6736(03)13859-7.
- Background: PubMed 20956824Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Correa C, McGale P, Taylor C, Wang Y, Clarke M, Davies C, Peto R, Bijker N, Solin L, Darby S. Overview of the randomized trials of radiotherapy in ductal carcinoma in situ of the breast. J Natl Cancer Inst Monogr. 2010;2010(41):162-77. doi: 10.1093/jncimonographs/lgq039.
- Background: PubMed 21128819Kaplan CP, Napoles AM, Hwang ES, Bloom J, Stewart S, Nickleach D, Karliner L. Selection of treatment among Latina and non-Latina white women with ductal carcinoma in situ. J Womens Health (Larchmt). 2011 Feb;20(2):215-23. doi: 10.1089/jwh.2010.1986. Epub 2010 Dec 3.
- Background: PubMed 9469327Fisher B, Dignam J, Wolmark N, Mamounas E, Costantino J, Poller W, Fisher ER, Wickerham DL, Deutsch M, Margolese R, Dimitrov N, Kavanah M. Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17. J Clin Oncol. 1998 Feb;16(2):441-52. doi: 10.1200/JCO.1998.16.2.441.
- Background: PubMed 21630124Fong J, Kurniawan ED, Rose AK, Mou A, Collins JP, Miller JA, Mann GB. Outcomes of screening-detected ductal carcinoma in situ treated with wide excision alone. Ann Surg Oncol. 2011 Dec;18(13):3778-84. doi: 10.1245/s10434-011-1748-6. Epub 2011 Jun 1.
- Background: PubMed 16461781Wong JS, Kaelin CM, Troyan SL, Gadd MA, Gelman R, Lester SC, Schnitt SJ, Sgroi DC, Silver BJ, Harris JR, Smith BL. Prospective study of wide excision alone for ductal carcinoma in situ of the breast. J Clin Oncol. 2006 Mar 1;24(7):1031-6. doi: 10.1200/JCO.2005.02.9975. Epub 2006 Feb 6.
- BackgroundPickle LW, MungioleM, Jones GK, White AA. Atlas of United States Mortality. Hyattsville, MD: Centers for Disease Control and Prevention; December 1996. http://www.cdc.gov/nchs/data/misc/atlasmet.pdf. Accessed September 1, 2015.
- Individual participant dataSharing planned: No
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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.
Rinaa S. Punglia, MD, MPH principal investigator
Dana-Farber Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DCIS, run by Dana-Farber Cancer Institute at 4 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?
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: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 6 Sep 2019). 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?
Association Between Patient Characteristics and Three-Level Cluster of Treatment Intensity for Primary DCIS (time frame: 20 Years). 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 NCT02248662, which also lists 14 linked publications.
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 6 Sep 2019.