Digital Tomosynthesis vs. Standard Mammography for Breast Cancer Screening

Not currently recruiting at 164 trial locations

Overseen By Leslie A. Welk

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: ECOG-ACRIN Cancer Research Group

Must be taking: Hormone therapy

Disqualifiers: Breast cancer history, Breast enhancements, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two breast cancer screening methods: digital tomosynthesis mammography (also known as Digital Breast Tomosynthesis or 3D Mammography) and standard digital mammography (also known as 2D Mammography or Conventional Mammography). Researchers aim to determine if digital tomosynthesis is more effective at detecting breast cancer and reducing the need for additional tests. Women who have not had a mammogram in the last 11 months and plan to schedule one may be eligible. Participants should have no current symptoms of breast issues and no history of breast cancer. Women with dense breast tissue, a family history of breast cancer, or those on hormone therapy might find this trial particularly relevant. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in breast cancer screening.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on hormone therapy, you may still be eligible to participate.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on hormone therapy, you can still participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both 3D mammography (digital tomosynthesis) and regular digital mammography are safe and well-tolerated for breast cancer screening. Studies have found that 3D mammography often results in fewer false alarms compared to regular digital mammography. This reduces unnecessary follow-ups or biopsies, which can be stressful and uncomfortable.

Regular digital mammography has effectively reduced deaths from breast cancer by detecting cancer early, though it may produce more false alarms than 3D mammography.

Both methods are widely used and approved for breast cancer screening, confirming their safety. Side effects are rare and usually minor, such as slight discomfort during the procedure. Overall, these screening tools are considered safe and effective for detecting breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it directly compares digital tomosynthesis mammography (TM) with standard digital mammography (DM) for breast cancer screening. Unlike traditional digital mammography, which provides a flat, two-dimensional image, digital tomosynthesis creates a three-dimensional picture of the breast by capturing multiple images from different angles. This 3D imaging technique can potentially detect smaller tumors and reduce the number of false positives, making it a promising advancement in early breast cancer detection. By examining both pre-menopausal and post-menopausal women, the trial aims to determine if digital tomosynthesis offers a significant improvement over the current standard of care in diverse patient groups.

What evidence suggests that this trial's screening methods could be effective for breast cancer?

Research has shown that digital breast tomosynthesis (DBT), which participants in this trial may receive, can be more effective than standard digital mammography (DM), another option in this trial, for breast cancer screening. Studies have found that DBT detects more cancers and results in fewer people needing to return for additional tests after their first screening. For instance, one study showed that DBT found more cancers and reduced the need for follow-up tests over three screening rounds. Another study found that DBT was better at correctly identifying people who do not have breast cancer. While DM remains commonly used and effective, DBT may provide clearer results and require fewer follow-up tests. ^{2 3 5 6 7}

Who Is on the Research Team?

Etta Pisano

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I don't need a diagnostic mammogram for any breast disease symptoms.

I plan to, or have scheduled, a mammogram.

Patients must not have had a screening mammogram within the last 11 months prior to date of randomization

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active Screening

Participants undergo digital tomosynthesis mammography or digital mammography at specified intervals

4 years

Baseline, 12, 24, 36, and 48 months for pre-menopausal; Baseline, 24, and 48 months for post-menopausal

Follow-up

Participants are monitored for safety and effectiveness after the last screening

3-8 years

What Are the Treatments Tested in This Trial?

Interventions

• Digital Mammography
• Digital Tomosynthesis Mammography

Trial Overview

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.

How Is the Trial Designed?

Group I: Arm B (digital tomosynthesis mammography) Experimental Treatment 2 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 Treatment 2 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.

Digital Mammography is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as Digital Mammography for:

• Breast cancer screening

Approved in European Union as Digital Mammography for:

• Breast cancer screening

Approved in Canada as Digital Mammography for:

• Breast cancer screening

Approved in Japan as Digital Mammography for:

• Breast cancer screening

Approved in China as Digital Mammography for:

• Breast cancer screening

Approved in Switzerland as Digital Mammography for:

• Breast cancer screening

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Canadian Cancer Trials Group (CCTG)

Collaborator

Trials

2

Recruited

109,000+

Published Research Related to This Trial

Digital breast tomosynthesis (DBT) combined with digital mammography (DM) shows sustainable improvements in breast cancer screening outcomes over four years, including a significant reduction in recall rates compared to DM alone (from 104 to 92 per 1000 screened).

The number of cancer cases detected per recalled patient increased with DBT screenings, indicating enhanced detection capabilities, while interval cancer rates decreased from 0.7 to 0.5 per 1000 women screened, suggesting improved safety and efficacy of the screening method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Digital Breast Tomosynthesis Compared With Digital Mammography: Outcomes Analysis From 3 Years of Breast Cancer Screening. McDonald, ES., Oustimov, A., Weinstein, SP., et al.[2017]

Screening with 3D digital breast tomosynthesis (DBT) resulted in a 16.1% lower recall rate compared to 2D digital mammography (DM), indicating fewer patients were called back for additional testing, which can reduce anxiety and unnecessary procedures.

The overall cancer detection rate (CDR) was 28.6% higher for 3D DBT (6.3 cancers per 1000 patients) compared to 2D DM (4.9 per 1000), with a significant increase in the detection of invasive cancers, suggesting that 3D DBT is more effective in identifying breast cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical performance metrics of 3D digital breast tomosynthesis compared with 2D digital mammography for breast cancer screening in community practice. Greenberg, JS., Javitt, MC., Katzen, J., et al.[2016]

In a study involving 238 cases of non-calcific, screen-detected mammographic abnormalities, digital breast tomosynthesis (DBT) using Siemens equipment showed a slightly higher diagnostic accuracy compared to supplementary mammographic views (SMVs), but the difference was not statistically significant.

Both DBT and SMVs demonstrated equivalent diagnostic accuracy for detecting benign and malignant cases, suggesting that DBT can be used effectively in place of SMVs in breast cancer screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical performance of Siemens digital breast tomosynthesis versus standard supplementary mammography for the assessment of screen-detected soft-tissue abnormalities: a multi-reader study. Whelehan, P., Heywang-Köbrunner, SH., Vinnicombe, SJ., et al.[2018]

Digital breast tomosynthesis (DBT) enhances breast cancer screening by improving both sensitivity and specificity compared to traditional 2D mammography, leading to better detection of cancers at earlier stages.

DBT eliminates the need for full-exposure 2D mammograms, suggesting it will become the standard method for breast cancer screening, potentially reducing recall rates and improving patient access to effective screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital breast tomosynthesis from concept to clinical care. Kopans, DB.[2016]

In a study of 35,736 women screened over eight years, digital breast tomosynthesis (DBT) showed lower recall rates and higher rates of screen-detected breast cancer compared to standard digital mammography (DM), indicating improved efficacy in cancer detection.

The positive predictive values for DBT were higher than for DM, and while DBT detected more favorable tumor characteristics, there were no differences in interval cancer rates between the two screening methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening outcome for consecutive examinations with digital breast tomosynthesis versus standard digital mammography in a population-based screening program. Hovda, T., Brandal, SHB., Sebuødegård, S., et al.[2021]

In a study involving 24,901 women aged 50 to 69, the combination of current reconstructed 2D images with digital breast tomosynthesis (DBT) showed similar cancer detection rates to standard full-field digital mammography (FFDM) plus DBT, indicating its effectiveness as a screening method.

The false-positive rates were also comparable between the two methods, suggesting that the current reconstructed 2D images can be safely used in routine clinical practice without increasing unnecessary anxiety for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-view digital breast tomosynthesis screening with synthetically reconstructed projection images: comparison with digital breast tomosynthesis with full-field digital mammographic images. Skaane, P., Bandos, AI., Eben, EB., et al.[2016]

In a study involving 1227 women aged 40-49 with a family history of breast cancer, the addition of digital breast tomosynthesis (DBT) to 2D mammography did not significantly reduce recall rates, with false positive rates being similar for both methods (2.4% for 2D vs. 2.2% for 2D+DBT).

However, DBT showed a significant reduction in the number of women with abnormal reads who were not recalled after further review, suggesting that while it may not lower recall rates, it could improve the accuracy of readings over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised trial of screening with digital breast tomosynthesis plus conventional digital 2D mammography versus 2D mammography alone in younger higher risk women. Maxwell, AJ., Michell, M., Lim, YY., et al.[2022]

Using digital breast tomosynthesis (DBT) combined with synthesized two-dimensional mammography (s2D) significantly improves cancer detection rates (CDR) by 35% compared to traditional digital mammography (DM) alone, while also reducing recall rates.

The combination of DBT and s2D leads to higher positive predictive values for recalls (PPV-1) and biopsies recommended (PPV-2), indicating better diagnostic accuracy without increasing biopsy rates, making it a safer and more effective screening option for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital breast tomosynthesis (DBT) plus synthesised two-dimensional mammography (s2D) in breast cancer screening is associated with higher cancer detection and lower recalls compared to digital mammography (DM) alone: results of a systematic review and meta-analysis. Heywang-Köbrunner, SH., Jänsch, A., Hacker, A., et al.[2022]

In a study of 17,955 screening mammograms, the combination of digital breast tomosynthesis (3D) with conventional mammography (2D) resulted in a significantly lower recall rate of 7.8%, compared to 12.3% for conventional 2D mammography, indicating improved efficiency in screening.

The lower recall rates were particularly notable for patients with asymmetries and calcifications, suggesting that 3D imaging enhances the detection process and reduces unnecessary follow-ups, while also maintaining a high cancer detection rate of 5.9 cancers per 1000 examinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early clinical experience with digital breast tomosynthesis for screening mammography. Durand, MA., Haas, BM., Yao, X., et al.[2022]

In a study involving over 4.5 million women screened between 2015 and 2017, digital breast tomosynthesis (DBT) showed a modestly lower recall rate compared to 2D mammography, particularly benefiting younger women aged 40-44.

DBT was associated with a higher cancer detection rate and increased biopsy rates compared to 2D mammography, indicating its potential effectiveness in identifying breast cancer, although the impact on clinical outcomes is still uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Digital Breast Tomosynthesis for Breast Cancer Screening Among Women 40-64 Years Old. Richman, IB., Long, JB., Hoag, JR., et al.[2023]

Both 2-view and 1-view digital breast tomosynthesis (DBT) implementations showed similar effectiveness in detecting breast cancer, with no significant differences in sensitivity, specificity, or area under the curve (AUC) based on a study of 118 patient image sets evaluated by six observers.

The 1-view DBT method exposes patients to half the radiation dose compared to the 2-view method, suggesting it could be a safer option for breast cancer surveillance, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of two-view versus single-view digital breast tomosynthesis and 2D-mammography in breast cancer surveillance imaging. Hadjipanteli, A., Polyviou, P., Kyriakopoulos, I., et al.[2023]

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