Pre-Surgical MRI + Mammography for Breast Cancer

Recruiting at178 trial locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

Treatment Details

Interventions

• Breast surgery (Procedure)
• Magnetic resonance imaging (Procedure)
• Mammography (Procedure)

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+

Suzanne George

Alliance for Clinical Trials in Oncology

Chief Medical Officer since 2015

MD from Harvard Medical School

Evanthia Galanis

Alliance for Clinical Trials in Oncology

Chief Executive Officer since 2022

MD from Mayo Clinic

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

American College of Radiology Imaging Network

Collaborator

Trials

40

Recruited

466,000+