Pre-Surgical MRI + Mammography for Breast Cancer

Recruiting at 178 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

Must not be taking: Hormonal therapy, Tamoxifen, Aromatase inhibitors

Disqualifiers: Men, Bilateral breast cancer, BRCA mutations, 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: 6

317 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on hormonal therapy, tamoxifen, or aromatase inhibitors, or if you have had chemotherapy in the past 6 months.

What data supports the effectiveness of the treatment Pre-Surgical MRI + Mammography for Breast Cancer?

Research shows that using MRI before breast cancer surgery can help doctors make better decisions about the type of surgery needed, potentially reducing the number of mastectomies (removal of the breast) in some cases. ^{1 2 3 4 5}

Is pre-surgical MRI and mammography safe for breast cancer screening?

MRI is generally considered a safe tool for breast cancer screening, but it can lead to false-positive results, which might cause unnecessary stress and additional testing. ^{6 7 8 9 10}

How does pre-surgical MRI and mammography differ from other breast cancer treatments?

Pre-surgical MRI combined with mammography is unique because it provides a more detailed view of the breast, helping to detect cancer that might be missed by other imaging methods. This approach can influence surgical decisions by better assessing the extent of the disease, especially in patients with dense breast tissue or complex cancer presentations. ^{1 2 11 12 13}

What is the purpose of this trial?

The purpose of this study is to test whether patients undergoing a breast MRI (magnetic resonance imaging) before breast surgery will have better results after the surgery. Breast tumors are routinely evaluated using mammograms and ultrasound before surgery. This study would like to find out if using MRI in addition to mammography before surgery improves our ability to evaluate tumors and decide what kind of surgery is best for the patient.

Research Team

Isabelle Bedrosian, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for women over 18 with stage I-II breast cancer, who haven't had chemotherapy in the last 6 months, and are eligible for breast conserving therapy. They must not be pregnant or breastfeeding, have no history of bilateral breast cancer or previous invasive breast cancer in the same side, and cannot have BRCA gene mutations.

Inclusion Criteria

I am a candidate for breast-saving surgery based on exams and imaging.

My cancer is ER/PR negative and HER2 positive according to specific guidelines.

Non-pregnant and non-lactating

Exclusion Criteria

I have had breast cancer or DCIS in the same breast before.

I am scheduled for chemotherapy or targeted radiation before breast surgery.

I have cancer in both of my breasts.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants undergo preoperative staging with mammography and possibly breast MRI

1-2 weeks

1 visit (in-person)

Surgery

Participants undergo breast conserving surgery or mastectomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for local, regional, distant relapse and vital status

5 years

Minimum of every 4 months for the first 2 years, then every 6 months during years 3-5

Treatment Details

Interventions

• Breast surgery
• Magnetic resonance imaging
• Mammography

Trial Overview The study tests if using MRI before surgery leads to better outcomes than just mammography. It's checking whether MRI can improve tumor evaluation and surgical planning for patients with specific types of tumors that are ER/PR negative (<10%) and HER-2 positive/negative.

Participant Groups

Group I: Arm 2 (experimental) Experimental Treatment 3 Interventions

Patients undergo a clinical breast examination, mammography with ultrasound of breast and regional nodes and breast MRI followed by breast conserving surgery or mastectomy.

Group II: Arm 1 (control) Experimental Treatment 2 Interventions

Patients undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes followed by breast conserving surgery.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

American College of Radiology Imaging Network

Collaborator

Trials

40

Recruited

466,000+

Findings from Research

In a study of 320 high-risk women who underwent 757 breast MRI procedures from 2007 to 2013, the number of false-positive findings (harms) decreased with each subsequent MRI, indicating improved screening efficiency over time.

Despite the initial higher rate of false positives, breast MRI continued to successfully detect cancer, with a total of 6 malignancies identified from 75 biopsy procedures, demonstrating its ongoing utility as a screening tool for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Related Changes in Yield and Harms of Screening Breast Magnetic Resonance Imaging. Pederson, HJ., O'Rourke, C., Lyons, J., et al.[2015]

In a study of 9,208 women aged 40 to 64, those who underwent breast MRI experienced significantly more downstream medical events (39 additional mammary events and 19.6 additional extramammary events per 100 women) compared to those who had mammograms.

Breast MRI also resulted in higher overall healthcare costs, with an increase of $1,404 per woman in total spending and $31 more in out-of-pocket expenses, suggesting that while MRI may provide more information, it also leads to more procedures and costs that may not always be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Downstream Mammary and Extramammary Cascade Services and Spending Following Screening Breast Magnetic Resonance Imaging vs Mammography Among Commercially Insured Women. Ganguli, I., Keating, NL., Thakore, N., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Influence of preoperative MRI on the surgical management of patients with operable breast cancer. [2008]

2. England pubmed.ncbi.nlm.nih.gov

Does preoperative magnetic resonance imaging modify breast cancer surgery? [2019]

3. England pubmed.ncbi.nlm.nih.gov

Breast magnetic resonance imaging use in patients undergoing neoadjuvant chemotherapy is associated with less mastectomies in large ductal cancers but not in lobular cancers. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Standardized pretreatment breast MRI--accuracy and influence on mastectomy decisions. [2018]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Preoperative Magnetic Resonance Imaging and Survival Outcomes in T1-2 Breast Cancer Patients Who Receive Breast-Conserving Therapy. [2020]

6. Canada pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging as an Adjunct to Mammography for Breast Cancer Screening in Women at Less Than High Risk for Breast Cancer: A Health Technology Assessment. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Time-Related Changes in Yield and Harms of Screening Breast Magnetic Resonance Imaging. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Factors associated with MRI detection of occult lesions in newly diagnosed breast cancers. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Downstream Mammary and Extramammary Cascade Services and Spending Following Screening Breast Magnetic Resonance Imaging vs Mammography Among Commercially Insured Women. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Association of routine pretreatment magnetic resonance imaging with time to surgery, mastectomy rate, and margin status. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Overview of the role of pre-operative breast MRI in the absence of evidence on patient outcomes. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Additional Workups Recommended During Preoperative Breast MRI: Methods to Gain Efficiency and Limit Confusion. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Impact of preoperative breast MRI on surgical decision making and clinical outcomes: a systematic review. [2021]