Breast CancerBCSC-ADVANCENCT02980848
Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study
An observational study of Breast Cancer, run by University of California, Davis at 7 sites in United States.
Trial summary
This Breast Cancer Surveillance Consortium (BCSC) ADVANCE study is a large, observational pragmatic comparative effectiveness research study using high-quality, prospectively collected data from BCSC registries to generate evidence on how breast density should be integrated into decision making around breast cancer… Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Screening digital mammography, Screening digital breast tomosynthesis and Screening breast magnetic resonance imaging
- How many people
- 1,341,172 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2016to Feb 2022
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study will include women age 40-79 undergoing screening mammography (Aim 1) and women age ≥18 with a first breast cancer diagnosis (Aim 2). We will include women in the BCSC cohort with mammography from 2005-2017. BCSC participants are identified from seven BCSC breast imaging registries. The BCSC prospectively collects data during routine clinical practice through voluntary partnerships with radiology facilities. Women enter the BCSC cohort when they receive a breast-imaging exam at a participating facility.
Who may be able to join
- Women aged 40-79 undergoing screening mammography from 2010-2017 for comparisons with tomosynthesis and 2005-2017 for comparison with breast MRI at a facility that participates in one of six BCSC breast imaging registries
- Digital mammography exams performed for screening and performed with or without supplemental screening with digital breast tomosynthesis from 2010-2017 or breast MRI from 2005-2017, at a facility that participates in one of seven BCSC breast imaging registries, and in women who meet inclusion criteria.
- Women aged 40-74 years undergoing screening mammography, with or without supplemental screening with digital breast tomosynthesis or breast MRI, at selected BCSC facilities
- Women within 12 months of a digital screening mammogram with known breast density and no known breast cancer diagnosis
- For MRI subgroup, we will include women with a screening MRI within the prior 24 months
- Within strata defined by BCSC registry, breast density subgroup (dense vs. not dense), and race/ethnicity, women with supplemental screening with digital breast tomosynthesis or breast MRI will be matched to women without supplemental screening
Show all 29Show fewer
- Aim 1 Focus Groups
- Women age 40-74 years undergoing screening mammography, with or without supplemental screening (defined as digital breast tomosynthesis or breast MRI)
- Women within 12 months post-most recent screening examination with known dense breasts from most recent screening mammogram and no known breast cancer diagnosis
- Women who are able to speak English and can travel to a nearby location for a discussion
- Subaim 1
- Radiologists interpreting digital mammography and/or tomosynthesis for at least one year from 2010-2017 at a facility that participates in the BCSC
- Digital mammography exams and digital breast tomosynthesis performed for screening and evaluated by a radiologist meeting inclusion criteria from 2010-2017
- Women at least 18 years of age with a first breast cancer diagnosis (DCIS or invasive) from 2005-2017 for whom there was a mammogram performed within the year prior to breast cancer diagnosis at one of the participating BCSC registry facilities
- Women for whom we have pathologically-confirmed breast cancer (DCIS or invasive) with a pathology or biopsy record related to the incident cancer diagnosis in the BCSC data
- MRI and mammography examinations performed for pre-operative work-up from 2005-2017 at one of the participating BCSC registry facilities in women meeting eligibility criteria
- Aim 2 Patient Reported Outcomes
- Women at least 18 years of age with a first pathology-confirmed breast cancer diagnosis (DCIS or stage I-III invasive) within 6-18 months
- Known breast density at the time of breast cancer diagnosis
- Aim 2 Focus Groups
- Women age ≥18 with a first breast cancer diagnosis (DCIS or stage I-III invasive cancer) within 1-5 years and after completion of active breast cancer treatment who have undergone mammography or MRI pre-operatively.
- Women who are able to speak English and can travel to a nearby location for a discussion
- COVID-19 Enhancement Focus Groups
- Women age 18-74 who were due for breast imaging services during the COVID pandemic and have either canceled their appointment, delayed their appointment, or kept their appointment
- Women who are able to speak English and can attend calls virtually through Zoom or over the phone
- In addition, for focus groups with women who have prior breast cancer:
- First breast cancer diagnosis (DCIS or stage I-III invasive cancer) within 1-3 years prior to March, 2020.
- Completed active cancer treatment (ongoing endocrine and Herceptin therapy acceptable)
- No evidence of a second breast cancer event in cancer registry or pathology data before recruitment.
Who cannot join
- Exams performed on women with a history of breast cancer, mastectomy, or breast augmentation.
- Unilateral mammograms and mammograms performed within 9 months of a prior mammogram to avoid classifying diagnostic exams as screening
- Exams without complete cancer capture during the follow-up period
- Aim 1 Patient Reported Outcomes
- Exams performed on women with a history of breast cancer, mastectomy, or breast augmentation
- Unilateral mammograms and mammograms performed within 9 months of a prior mammogram to avoid classifying diagnostic exams as screening
- Exams without complete cancer capture during one year following the screening mammogram
- Aim 2 Clinical Outcomes
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Vermont Breast Cancer Surveillance System
Burlington, Vermont, 05405
Carolina Mammography Registry
Chapel Hill, North Carolina, 27599
Metro Chicago Breast Cancer Registry
Chicago, Illinois, 60607
Sacramento Area Breast Imaging Registry
Davis, California, 95616
New Hampshire Mammography Network
Lebanon, New Hampshire, 03755
San Francisco Mammography Registry
San Francisco, California, 94143
Kaiser Permanente Washington Breast Cancer Surveillance Registry
Seattle, Washington, 98101
About this study
Official title: Comparative Effectiveness of Breast Cancer Screening and Diagnostic Evaluation by Extent of Breast Density
This Breast Cancer Surveillance Consortium (BCSC) ADVANCE study is a large, observational pragmatic comparative effectiveness research study using high-quality, prospectively collected data from BCSC registries to generate evidence on how breast density should be integrated into decision making around breast cancer screening and preoperative diagnostic work-up. We will augment existing BCSC registry infrastructure with additional prospective data collection and collection of patient reported outcomes (PROs), CISNET modeling of long-term screening outcomes, and qualitative data from focus groups with women represented in two aims.
Read the detailed description
Aim 1: Compare the effectiveness of breast cancer screening using digital mammography alone versus digital mammography plus supplemental screening (digital breast tomosynthesis or MRI) by extent of breast density.
Sub aim 1: Evaluate whether the performance of tomosynthesis improves with years of experience, and whether any "learning curve" depends on radiologist specialty (i.e., breast imaging specialist vs. general radiologist).
Aim 2: Compare the effectiveness of preoperative MRI versus no MRI by extent of breast density among women with an initial, pathologically confirmed diagnosis of DCIS or invasive breast cancer.
Covid-19 Enhancement Aim and Hypotheses:
Develop patient-focused messaging content through focus groups that radiology facilities can use when scheduling appointments to inform women of the safety to schedule or postpone breast screening or diagnostic services.
- Conditions
- Breast Cancer
- Being tested
- Screening digital mammography, Screening digital breast tomosynthesis, Screening breast magnetic resonance imaging, Diagnostic mammography, Pre-operative breast magnetic resonance imaging
- Keywords
- digital mammography, digital breast tomosynthesis, breast magnetic resonance imaging, screening, breast density, breast imaging, pre-operative magnetic resonance imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening digital mammographyOther
Screening with digital mammography alone
Screening digital breast tomosynthesisOther
Screening with digital mammography plus digital breast tomosynthesis
Screening breast magnetic resonance imagingOther
Screening with digital mammography plus breast magnetic resonance imaging
Diagnostic mammographyOther
Pre-operative diagnostic work-up with mammography alone
Pre-operative breast magnetic resonance imagingOther
Pre-operative diagnostic work-up with mammography plus breast magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| Screening group | Women without a history of breast cancer undergoing screening digital mammography, screening digital breast tomosynthesis, or screening breast magnetic resonance imaging. Receives: Other: Screening digital mammography; Other: Screening digital breast tomosynthesis; Other: Screening breast magnetic resonance imaging | |
| Women with breast cancer | Women diagnosed with stage 0-III breast cancer undergoing pre-operative work-up with diagnostic mammography alone or diagnostic mammography plus pre-operative breast magnetic resonance imaging. Receives: Other: Diagnostic mammography; Other: Pre-operative breast magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening Benefits: Rate of early stage invasive cancer detection (Aim 1)
Number of stage I or IIA cancers diagnosed within 1 year of a positive screen divided by total number of screens
Measured: Within one year after screen
Screening Failures: Interval or advanced breast cancer rate (Aim 1)
Number of invasive cancer cases within 1 year of a negative screen divided by total number of screens
Number of advanced cancers (stage IIB or higher) within 1 year of a screen divided by total number of screens
Measured: Within one year after screen
Screening Harms: Recall rate (Aim 1)
Number of positive screens divided by total number of screens
Measured: Within one year after screen
Screening Harms: False-positive (FP) recall rate (Aim 1)
Number of positive screens without a cancer diagnosed within 1 year divided by total number of screens
Measured: Within one year after screen
Screening Harms: FP biopsy recommendation rate (Aim 1)
Number of screens with a biopsy recommendation and no cancer diagnosed within 1 year divided by total number of screens
Measured: Within one year after screen
Screening Harms: Other consequences (Aim 1)
Number of DCIS diagnoses within 1 year of a positive screen divided by total number of screens, reported overall and by grade
Measured: Within one year after screen
Patient Reported Outcomes (Aim 1)
Patient surveys targeted to determining outcomes of interest to patients
Measured: Measured within one year post-screening
Rates of additional breast cancers detected (Aim 2)
Number of women with contralateral breast cancer diagnosed within 6 months of initial diagnosis over total number of women
Measured: 6 months after initial diagnosis
3-year rate of 2nd breast cancer events (Aim 2)
Rate of 2nd breast cancers diagnosed within 3 years of follow-up (starting 6 months after initial diagnosis) calculated separately for ipsilateral and contralateral cancers
Measured: 3 years after initial diagnosis
Patient Reported Outcomes (Aim 2)
Patient surveys targeted to determining outcomes of interest to patients
Measured: Measured 6-18 months post-diagnosis
Secondary outcomes (9)
Performance Measures: Sensitivity (Aim 1)
Number of cancer cases within 1 year of positive screen divided by number of breast cancer cases
Measured: Within one year after screen
Performance Measures: Specificity (Aim 1)
Number of negative screens without cancer diagnosed within 1 year of screen divided by number of screens without breast cancer
Measured: Within one year after screen
Performance Measures: Positive predictive value (Aim 1)
Number of cancer cases within 1 year of positive screen divided by number of positive screens
Measured: Within one year after screen
Definitive surgery type (Aim 2)
Rates of unilateral mastectomy, or bilateral mastectomy, lumpectomy with reconstruction, lumpectomy without reconstruction
Measured: 6 months after initial diagnosis
Negative predictive value of work-up with MRI (Aim 2)
Number of women with a negative pre-operative MRI and no additional cancers diagnosed within 6 months after initial diagnosis over the total number of women with a negative pre-operative MRI
Measured: 6 months after initial diagnosis
Negative predictive value of work-up without MRI (Aim 2)
Number of women without a pre-operative MRI with no additional cancers diagnosed within 6 months after initial diagnosis over the total number of women without a pre-operative MRI
Measured: 6 months after initial diagnosis
Core biopsy rates (Aim 2)
Number of core biopsies within 6 months of initial diagnosis over number of breast biopsies
Measured: 6 months after initial diagnosis
Surgical biopsy rate (Aim 2)
Number of surgical biopsies within 6 months of initial diagnosis over number of breast biopsies
Measured: 6 months after initial diagnosis
Benign biopsy rate (Aim 2)
Number of initial benign biopsies over number of breast biopsies
Measured: 6 months after initial diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,341,172 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of California, San Francisco, Dartmouth College, Kaiser Permanente, University of Vermont, University of North Carolina, University of Illinois at Chicago, Wake Forest University Health Sciences, Harvard Pilgrim Health Care, Albert Einstein College of Medicine, Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Diana L Miglioretti, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980848
- Sponsor's protocol ID
- 941466
- Other IDs
- PCS-1504-30370
- Acronym
- BCSC-ADVANCE
- Status last verified
- Nov 2021
- First submitted
- 19 Nov 2016
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Please visit http://www.bcsc-research.org for information about requesting BCSC data.
Publications
Smith RE, Sprague BL, Henderson LM, Kerlikowske K, Miglioretti DL, Wernli KJ, Onega T, diFlorio-Alexander RM, Tosteson ANA. Breast density knowledge and willingness to delay treatment for pre-operative breast cancer imaging among women with a personal history of breast cancer. Breast Cancer Res. 2024 Apr 29;26(1):73. doi: 10.1186/s13058-024-01820-x.
PubMed 38685119Tosteson ANA, Schifferdecker KE, Smith RE, Wernli KJ, Zhao W, Kaplan CP, Buist DSM, Henderson LM, Sprague BL, Onega T, Budesky J, Jackson-Nefertiti G, Johnson D, Miglioretti DL, Kerlikowske K. Women's Breast Cancer Screening Confidence by Screening Modality and Breast Density: A Breast Cancer Surveillance Consortium Survey Study. J Womens Health (Larchmt). 2022 Nov;31(11):1547-1556. doi: 10.1089/jwh.2021.0649.
PubMed 36356184Onega T, Zhu W, Kerlikowske K, Miglioretti DL, Lee CI, Henderson LM, Tosteson ANA, Wernli KJ, diFlorio R, Weaver DL, Buist DSM. Preoperative MRI in breast cancer: effect of breast density on biopsy rate and yield. Breast Cancer Res Treat. 2022 Jan;191(1):177-190. doi: 10.1007/s10549-021-06418-x. Epub 2021 Oct 22.
PubMed 34686934
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Breast Cancer Screening and Diagnostic Evaluation by Extent of Breast Density
- ClinicalTrials.gov ID
- NCT02980848
- Acronym / sponsor ID
- BCSC-ADVANCE / 941466
- Conditions
- Breast Cancer
- Keywords
- digital mammography, digital breast tomosynthesis, breast magnetic resonance imaging, screening, breast density, breast imaging, pre-operative magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,341,172 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of California, San Francisco, Dartmouth College, Kaiser Permanente, University of Vermont, University of North Carolina, University of Illinois at Chicago, Wake Forest University Health Sciences, Harvard Pilgrim Health Care, Albert Einstein College of Medicine, Erasmus Medical Center
- Study start
- Sep 2016
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Breast Cancer Surveillance Consortium (BCSC) ADVANCE study is a large, observational pragmatic comparative effectiveness research study using high-quality, prospectively collected data from BCSC registries to generate evidence on how breast density should be integrated into decision making around breast cancer screening and preoperative diagnostic work-up. We will augment existing BCSC registry infrastructure with additional prospective data collection and collection of patient reported outcomes (PROs), CISNET modeling of long-term screening outcomes, and qualitative data from focus groups with women represented in two aims.
Detailed description
Aim 1: Compare the effectiveness of breast cancer screening using digital mammography alone versus digital mammography plus supplemental screening (digital breast tomosynthesis or MRI) by extent of breast density.
Sub aim 1: Evaluate whether the performance of tomosynthesis improves with years of experience, and whether any "learning curve" depends on radiologist specialty (i.e., breast imaging specialist vs. general radiologist).
Aim 2: Compare the effectiveness of preoperative MRI versus no MRI by extent of breast density among women with an initial, pathologically confirmed diagnosis of DCIS or invasive breast cancer.
Covid-19 Enhancement Aim and Hypotheses:
Develop patient-focused messaging content through focus groups that radiology facilities can use when scheduling appointments to inform women of the safety to schedule or postpone breast screening or diagnostic services.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening group | – | Other: Screening digital mammography, Other: Screening digital breast tomosynthesis, Other: Screening breast magnetic resonance imagingWomen without a history of breast cancer undergoing screening digital mammography, screening digital breast tomosynthesis, or screening breast magnetic resonance imaging. |
| Women with breast cancer | – | Other: Diagnostic mammography, Other: Pre-operative breast magnetic resonance imagingWomen diagnosed with stage 0-III breast cancer undergoing pre-operative work-up with diagnostic mammography alone or diagnostic mammography plus pre-operative breast magnetic resonance imaging. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include women age 40-79 undergoing screening mammography (Aim 1) and women age ≥18 with a first breast cancer diagnosis (Aim 2). We will include women in the BCSC cohort with mammography from 2005-2017. BCSC participants are identified from seven BCSC breast imaging registries. The BCSC prospectively collects data during routine clinical practice through voluntary partnerships with radiology facilities. Women enter the BCSC cohort when they receive a breast-imaging exam at a participating facility.
Key inclusion criteria (29 listed)
- Women aged 40-79 undergoing screening mammography from 2010-2017 for comparisons with tomosynthesis and 2005-2017 for comparison with breast MRI at a facility that participates in one of six BCSC breast imaging registries
- Digital mammography exams performed for screening and performed with or without supplemental screening with digital breast tomosynthesis from 2010-2017 or breast MRI from 2005-2017, at a facility that participates in one of seven BCSC breast imaging registries, and in women who meet inclusion criteria.
- Women aged 40-74 years undergoing screening mammography, with or without supplemental screening with digital breast tomosynthesis or breast MRI, at selected BCSC facilities
- Women within 12 months of a digital screening mammogram with known breast density and no known breast cancer diagnosis
- For MRI subgroup, we will include women with a screening MRI within the prior 24 months
Key exclusion criteria (8 listed)
- Exams performed on women with a history of breast cancer, mastectomy, or breast augmentation.
- Unilateral mammograms and mammograms performed within 9 months of a prior mammogram to avoid classifying diagnostic exams as screening
- Exams without complete cancer capture during the follow-up period
- Aim 1 Patient Reported Outcomes
- Exams performed on women with a history of breast cancer, mastectomy, or breast augmentation
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 |
|---|---|---|
| Screening digital mammographyScreening with digital mammography alone | Other | Screening group |
| Screening digital breast tomosynthesisScreening with digital mammography plus digital breast tomosynthesis | Other | Screening group |
| Screening breast magnetic resonance imagingScreening with digital mammography plus breast magnetic resonance imaging | Other | Screening group |
| Diagnostic mammographyPre-operative diagnostic work-up with mammography alone | Other | Women with breast cancer |
| Pre-operative breast magnetic resonance imagingPre-operative diagnostic work-up with mammography plus breast magnetic resonance imaging | Other | Women with breast cancer |
Primary outcome
Screening Benefits: Rate of early stage invasive cancer detection (Aim 1)
Time frame: Within one year after screen
Number of stage I or IIA cancers diagnosed within 1 year of a positive screen divided by total number of screens
Screening Failures: Interval or advanced breast cancer rate (Aim 1)
Time frame: Within one year after screen
Number of invasive cancer cases within 1 year of a negative screen divided by total number of screens Number of advanced cancers (stage IIB or higher) within 1 year of a screen divided by total number of screens
Screening Harms: Recall rate (Aim 1)
Time frame: Within one year after screen
Number of positive screens divided by total number of screens
Screening Harms: False-positive (FP) recall rate (Aim 1)
Time frame: Within one year after screen
Number of positive screens without a cancer diagnosed within 1 year divided by total number of screens
Screening Harms: FP biopsy recommendation rate (Aim 1)
Time frame: Within one year after screen
Number of screens with a biopsy recommendation and no cancer diagnosed within 1 year divided by total number of screens
Screening Harms: Other consequences (Aim 1)
Time frame: Within one year after screen
Number of DCIS diagnoses within 1 year of a positive screen divided by total number of screens, reported overall and by grade
Patient Reported Outcomes (Aim 1)
Time frame: Measured within one year post-screening
Patient surveys targeted to determining outcomes of interest to patients
Rates of additional breast cancers detected (Aim 2)
Time frame: 6 months after initial diagnosis
Number of women with contralateral breast cancer diagnosed within 6 months of initial diagnosis over total number of women
3-year rate of 2nd breast cancer events (Aim 2)
Time frame: 3 years after initial diagnosis
Rate of 2nd breast cancers diagnosed within 3 years of follow-up (starting 6 months after initial diagnosis) calculated separately for ipsilateral and contralateral cancers
Patient Reported Outcomes (Aim 2)
Time frame: Measured 6-18 months post-diagnosis
Patient surveys targeted to determining outcomes of interest to patients
9 secondary outcomes
Performance Measures: Sensitivity (Aim 1)
Time frame: Within one year after screen
Performance Measures: Specificity (Aim 1)
Time frame: Within one year after screen
Performance Measures: Positive predictive value (Aim 1)
Time frame: Within one year after screen
Definitive surgery type (Aim 2)
Time frame: 6 months after initial diagnosis
Negative predictive value of work-up with MRI (Aim 2)
Time frame: 6 months after initial diagnosis
Negative predictive value of work-up without MRI (Aim 2)
Time frame: 6 months after initial diagnosis
Core biopsy rates (Aim 2)
Time frame: 6 months after initial diagnosis
Surgical biopsy rate (Aim 2)
Time frame: 6 months after initial diagnosis
Benign biopsy rate (Aim 2)
Time frame: 6 months after initial diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Derived from this study: PubMed 38685119Smith RE, Sprague BL, Henderson LM, Kerlikowske K, Miglioretti DL, Wernli KJ, Onega T, diFlorio-Alexander RM, Tosteson ANA. Breast density knowledge and willingness to delay treatment for pre-operative breast cancer imaging among women with a personal history of breast cancer. Breast Cancer Res. 2024 Apr 29;26(1):73. doi: 10.1186/s13058-024-01820-x.
- Derived from this study: PubMed 36356184Tosteson ANA, Schifferdecker KE, Smith RE, Wernli KJ, Zhao W, Kaplan CP, Buist DSM, Henderson LM, Sprague BL, Onega T, Budesky J, Jackson-Nefertiti G, Johnson D, Miglioretti DL, Kerlikowske K. Women's Breast Cancer Screening Confidence by Screening Modality and Breast Density: A Breast Cancer Surveillance Consortium Survey Study. J Womens Health (Larchmt). 2022 Nov;31(11):1547-1556. doi: 10.1089/jwh.2021.0649.
- Derived from this study: PubMed 34686934Onega T, Zhu W, Kerlikowske K, Miglioretti DL, Lee CI, Henderson LM, Tosteson ANA, Wernli KJ, diFlorio R, Weaver DL, Buist DSM. Preoperative MRI in breast cancer: effect of breast density on biopsy rate and yield. Breast Cancer Res Treat. 2022 Jan;191(1):177-190. doi: 10.1007/s10549-021-06418-x. Epub 2021 Oct 22.
- Breast Cancer Surveillance Consortium (BCSC)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Please visit http://www.bcsc-research.org for information about requesting BCSC data.
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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.
Diana L Miglioretti, PhD principal investigator
University of California, Davis
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of California, Davis at 7 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 29 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
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?
Screening Benefits: Rate of early stage invasive cancer detection (Aim 1) (time frame: Within one year after screen). The study lists 10 primary outcomes in all. 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 NCT02980848, which also lists 3 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 17 Nov 2021.