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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
Eligible for breast conserving therapy (BCT) based on clinical examination, mammography, and, if standard practice at a given institution, ultrasound and/or tomogram
Patients with ER negative/PR negative (< 10% by IHC staining) and HER-2 positive tumors as per the 2013 ASCO CAP guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I am a candidate for breast-saving surgery based on exams and imaging.
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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.

Timeline

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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Local-regional recurrence (LRR)
Secondary outcome measures
Breast cancer specific survival will be measured
Conversion rate to mastectomy secondary to persistent positive margins or poor cosmesis
Disease-free survival (DFS)
+5 more

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
Mammography
2015
N/A
~1450

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,321 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,836 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
American College of Radiology Imaging NetworkNETWORK
39 Previous Clinical Trials
466,558 Total Patients Enrolled
8 Trials studying Breast Cancer
51,457 Patients Enrolled for Breast Cancer

Media Library

Breast surgery Clinical Trial Eligibility Overview. Trial Name: NCT01805076 — Phase 3
Breast Cancer Research Study Groups: Arm 1 (control), Arm 2 (experimental)
Breast Cancer Clinical Trial 2023: Breast surgery Highlights & Side Effects. Trial Name: NCT01805076 — Phase 3
Breast surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT01805076 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the federal government given its stamp of approval to Breast surgery?

"Breast surgery has received a 3 for safety. This is due to the fact that it is a phase 3 trial, so there is both some efficacy data as well as multiple rounds of safety data."

Answered by AI

Are there any Canadian sites conducting this research?

"Out of the total 200 sites, 100 are currently recruiting patients. The locations nearest you that are participating in the trial are Neenah, Morgantown and Greer. Reducing travel is important, so please select the location that is most convenient."

Answered by AI

Are there any open slots for patients in this research project?

"The information available on clinicaltrials.gov suggests that this study is not actively recruiting patients at this moment. This trial was originally posted on February 1st, 2014 and was last edited on August 1st, 2022. There are 2424 other trials that are currently looking for participants."

Answered by AI
~22 spots leftby Feb 2025