Pre-Surgical MRI + Mammography for Breast Cancer

No longer recruiting at 182 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding an MRI (a detailed imaging test) before breast surgery leads to better outcomes compared to the usual approach of using only mammograms and ultrasounds. The researchers aim to determine if this additional step helps doctors make more informed decisions about the type of surgery needed for breast cancer patients. Women diagnosed with early-stage breast cancer through a needle biopsy and meeting certain health criteria, such as not having previous breast cancer or specific genetic mutations, may qualify to join this study. 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 treatment.

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.

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

Research has shown that having an MRI (magnetic resonance imaging) before surgery is generally safe for patients. Studies have found that using MRI before breast surgery helps doctors see the full extent of the disease more clearly, which is crucial for surgical planning. Available studies report no serious side effects directly linked to pre-surgical MRI.

MRI is a well-established tool in medicine, commonly used for various conditions. It is non-invasive, meaning it doesn't involve surgery or radiation, making it generally well-tolerated by most people.

In summary, current research considers pre-surgical MRI safe. It aids doctors in making better surgical decisions without adding significant risks to patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining pre-surgical MRI with mammography for breast cancer because it could improve surgical planning. The addition of MRI provides a more detailed image of the breast tissue, potentially allowing for more precise removal of cancerous areas and reducing the likelihood of needing additional surgeries. This technique aims to enhance the accuracy of breast-conserving surgeries or mastectomies, which could lead to better outcomes for patients compared to the standard approach of using mammography and ultrasound alone.

What evidence suggests that using pre-surgical MRI in addition to mammography could improve breast cancer surgery outcomes?

This trial will compare the outcomes of pre-surgical imaging methods for breast cancer. In Arm 1, the control group, patients will undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes, followed by breast-conserving surgery. In Arm 2, the experimental group, patients will receive the same examinations plus a breast MRI, followed by breast-conserving surgery or mastectomy.

Research suggests that an MRI before breast cancer surgery might reduce the risk of recurrence in women under 50. However, a review of several studies found that using an MRI before surgery didn't significantly affect the chance of cancer returning in the same breast. Another study showed that an MRI before surgery didn't change long-term outcomes for women with early-stage breast cancer. Overall, evidence on the effectiveness of MRIs in improving surgical results is mixed, with some benefits seen in specific groups but not universally. ^{4 6 7 8 9}

Who Is on the Research Team?

Isabelle Bedrosian, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubs.rsna.org pubs.rsna.org/doi/10.1148/radiol.250439

Preoperative Breast MRI and Survival Outcomes in Women ... Preoperative MRI was associated with reduced risk of ipsilateral breast cancer recurrence in patients 50 years or younger, with the greatest ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11971173/

The effect of pre-operative MRI on the in-breast tumor ... This meta-analysis found no significant reduction in in-breast tumor recurrence rates associated with preoperative MRI use in breast cancer patients.

3. cancernetwork.com cancernetwork.com/view/preoperative-breast-mri-does-not-improve-surgical-plan-local-control

Preoperative Breast MRI Does Not Improve Surgical Plan ... An additional study revealed that preoperative breast MRI had no impact on 15-year outcomes for BCS-managed DCIS (P = . 25) or early-stage ...

4. breastsurgeons.org breastsurgeons.org/docs/statements/Consensus-Guideline-on-Diagnostic-and-Screening-Magnetic-Resonance-Imaging-of-the-Breast.pdf

Diagnostic and Screening Magnetic Resonance Imaging of ... Preoperative breast MRI for early-stage breast cancer: effect on surgical and long-term outcomes. AJR Am J Roentgenol. 2014;202(6):1376- 1382. 9. Mann RM, ...

5. i-mri.org i-mri.org/pdf/10.13104/imri.2024.0025

The Role of Preoperative Breast MRI in Patients With Early- ... This re- view evaluates the existing literature on the influence of preoperative breast MRI on clinical outcomes in this patient population.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10036439/

Effects of preoperative magnetic resonance image on survival ... The use of preoperative MRI did not influence local relapse-free survival, overall survival, or reoperation rates. Keywords: Magnetic resonance ...

7. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.250439

Preoperative Breast MRI and Survival Outcomes in Women ... Preoperative MRI was associated with reduced risk of ipsilateral breast cancer recurrence in patients 50 years or younger, with the greatest ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7532157/

Preoperative magnetic resonance imaging use and ... Breast magnetic resonance imaging (MRI) delineates disease extent sensitively in newly diagnosed breast cancer patients, but improved cancer outcomes are ...

9. stacks.cdc.gov stacks.cdc.gov/view/cdc/124071/cdc_124071_DS1.pdf

Preoperative MRI in breast cancer We quantified breast biopsies and cancers detected within 6 months of diagnosis by preoperative breast MRI receipt, overall and by breast ...