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Digital Tomosynthesis vs. Standard Mammography for Breast Cancer Screening
Phase 3
Recruiting
Led By Etta Pisano
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women of childbearing potential must not be known to be pregnant or lactating
Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4.5 years after last registration
Awards & highlights
Study Summary
This trial looks at two ways of screening for breast cancer, and whether one is better than the other.
Who is the study for?
This trial is for women who are not pregnant or breastfeeding, have not had a mammogram in the last 11 months, and show no symptoms of breast disease. Women with dense breasts or postmenopausal women on hormone therapy or with family history/genetic risk for breast cancer may be eligible. Those with prior breast cancer or enhancements are excluded.Check my eligibility
What is being tested?
The study compares digital tomosynthesis mammography (3D imaging) and standard digital mammography (2D imaging) to see which is more effective for breast cancer screening and reducing unnecessary follow-up procedures.See study design
What are the potential side effects?
Mammography generally has minimal side effects; however, discomfort during the procedure can occur. There's also exposure to low-dose radiation, which carries a very small risk of potentially contributing to future cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant or breastfeeding.
Select...
I have never had breast cancer or ductal carcinoma in situ before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4.5 years after last registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4.5 years after last registration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of women diagnosed with an advanced breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of follow up after the last screen
Secondary outcome measures
Biopsy
Assess the predictive performance of tomosynthesis mammography (TM) and digital mammography (DM)
Biopsy rates
+14 moreSide effects data
From 2019 Phase 2 trial • 77 Patients • NCT012515755%
Hypoxia
5%
Febrile neutropenia
5%
Acute kidney injury
4%
Blood bilirubin increased
4%
Diarrhea
4%
Creatinine increased
4%
Sepsis
3%
Hypotension
3%
Left ventricular systolic dysfunction
3%
Bronchopulmonary hemorrhage
3%
Chronic kidney disease
3%
Thromboembolic event
3%
Lung infection
1%
Atrial fibrillation
1%
Atrial flutter
1%
Hemolysis
1%
Hemolytic uremic syndrome
1%
Ejection fraction decreased
1%
Encephalitis infection
1%
Gastric hemorrhage
1%
Gastritis
1%
Heart failure
1%
Mucositis oral
1%
Multi-organ failure
1%
Myalgia
1%
Pleural effusion
1%
Respiratory failure
1%
Small intestine infection
1%
Syncope
1%
Treatment related secondary malignancy
1%
Typhlitis
1%
Fever
1%
Paroxysmal atrial tachycardia
1%
Ascites
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Fludarabine, Transplant, Immunosuppression)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (digital tomosynthesis mammography)Experimental Treatment2 Interventions
Patients undergo manufacturer-defined screening TM at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal.
Group II: Arm A (digital mammography)Experimental Treatment2 Interventions
Patients undergo bilateral screening DM with standard CC and MLO views at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digital Tomosynthesis Mammography
2017
N/A
~140
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,797,168 Total Patients Enrolled
Canadian Cancer Trials Group (CCTG)UNKNOWN
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
48,017 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have symptoms like nipple discharge or breast lumps that need diagnostic tests.Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol.I have a family history of breast cancer or a positive genetic test for breast cancer risk.I don't need a diagnostic mammogram for any breast disease symptoms.Not applicable.I plan to, or have scheduled, a mammogram.I am not pregnant or breastfeeding.I have never had breast cancer or ductal carcinoma in situ before.I am currently receiving hormone therapy.My breast density was checked through a mammogram, and I know my risk factors for breast cancer screening.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (digital tomosynthesis mammography)
- Group 2: Arm A (digital mammography)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Mammogram Patient Testimony for trial: Trial Name: NCT03233191 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research include elderly individuals as test subjects?
"As this trial's eligibility requirements state, the minimum age for enrollment is 45 while the maximum is 74."
Answered by AI
Could you elaborate on how many hospitals are participating in this research project?
"This clinical trial has 100 recruiting patients at University of Iowa/Holden Comprehensive Cancer Center in Iowa City, Sidney Kimmel Cancer Center Washington Township in Sewell, Memorial Hermann Texas Medical Center in Houston and other locations."
Answered by AI
How many people are signing up to participate in this research project?
"In order to move forward with this study, 128905 patients that meet the eligibility requirements must enroll. The trial is being conducted at University of Iowa/Holden Comprehensive Cancer Center in Iowa City, Iowa and Sidney Kimmel Cancer Center Washington Township in Sewell, New jersey among other locations."
Answered by AI
What does the FDA think about Laboratory Biomarker Analysis?
"Laboratory Biomarker Analysis has received a score of 3 for safety. This is because it is a Phase 3 trial, meaning that there is data supporting both efficacy and multiple rounds of safety testing."
Answered by AI
How can I sign up to participate in this clinical trial?
"This study is recruiting 128905 people, between the ages of 45 and 74 who have breast screening. It is required that participants also meet the following criteria: - Women of childbearing potential must not be known to be pregnant or lactating - Patients must be scheduled for, or have intent to schedule, a screening mammogram - Patients must be willing and able to provide a written informed consent - Patients must not have symptoms or signs of benign or malignant breast disease (eg, nipple discharge, breast lump) warranting a diagnostic rather than a screening mammogram, and/or other imaging"
Answered by AI
Is this study still looking for participants?
"The trial, which is looking for participants, was first posted on 7/6/2017 and has been updated as recently as 6/8/2022 according to clinicaltrials.gov."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
Arizona
California
Other
How old are they?
65+
18 - 65
What site did they apply to?
Riverview Medical Center/Booker Cancer Center
M D Anderson Cancer Center
Zuckerberg San Francisco General Hospital
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
0
Why did patients apply to this trial?
To help other people. My mother has had 2 biopsies and a partial mastectomy due to breast cancer and now has to have a mammogram every 6 months on the remaining tissue. The burns she received from her radiation treatments were awful so I would like to help.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
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