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Pre-Surgical MRI + Mammography for Breast Cancer

Phase 3

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with ER negative/PR negative (< 10% by IHC staining) and HER-2 positive tumors as per the 2013 ASCO CAP guidelines

Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0) by needle biopsy

Must not have

Patients scheduled to receive neoadjuvant chemotherapy or partial breast irradiation following breast conserving surgery

Patients with bilateral breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether adding an MRI to the standard mammogram improves accuracy in diagnosing breast tumors before surgery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from lying still during the MRI scan, reactions to the contrast agent gadolinium such as nausea or a rash, anxiety due to claustrophobia inside the MRI machine, and very rarely kidney issues related to gadolinium.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My breast cancer is in the early stages (I or II) and was confirmed by a needle biopsy.

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I can have an MRI and use the contrast dye gadolinium.

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My breast cancer is not driven by estrogen, progesterone, or HER2.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have cancer in both of my breasts.

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

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I am male.

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I am a woman who cannot have breast-conserving therapy based on imaging results.

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I am scheduled for several lumpectomies due to cancer in multiple locations.

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My diagnosis was confirmed through surgery.

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I have harmful changes in my BRCA genes.

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I have a history of sickle cell disease.

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I cannot receive IV contrast due to health reasons.

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I weigh less than the MRI table's maximum limit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2 (experimental)Experimental Treatment3 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 Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Breast surgery

2016

Completed Phase 2

~1580

Magnetic resonance imaging

2016

Completed Phase 3

~1240