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MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer

Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01805076
Enrollment
319
Registered
2013-03-06
Start date
2014-05-21
Completion date
2025-05-27
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Estrogen Receptor-negative Breast Cancer, Progesterone Receptor-negative Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Triple-negative Breast Cancer

Brief summary

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.

Detailed description

This is a randomized trial of preoperative breast MRI in patients deemed eligible for breast conserving surgery by conventional clinical criteria will provide important information about the clinical and biologic relevance of occult disease identified by MRI alone. Patients will be assigned to standard pre-operative breast cancer disease assessment without the addition of MRI prior to breast conserving surgery or standard pre-operative breast cancer disease assessment with the use of MRI prior to breast conserving surgery. The primary objective is to compare the rates of local-regional recurrence (LRR) following attempted breast conserving therapy in a cohort of women with triple negative or HER-2 amplified breast cancer randomized to preoperative staging with mammography (control arm) or mammography plus breast MRI (MRI arm). Secondary objectives are: * To compare the re-operation rates following attempted breast conserving therapy between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI * To compare local recurrence rates between women who undergo BCT on the control arm to women who undergo BCT on the MRI arm * To compare the conversion rate to mastectomy secondary to persistent positive margins or poor cosmesis within the first 6 months of attempting BCT (prior to the administration of RT) between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI * To compare the contralateral breast cancer rates in women randomized to preoperative breast MRI to those not receiving pre-operative breast MRI * To compare the disease-free survival rates between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI * To compare breast cancer specific and overall survival outcomes of women assessed preoperatively with breast MRI to those assessed without the use of breast MRI * To estimate the rate of MRI-guided localization assisted surgery * To estimate the rate of multi-centric disease in the index breast for women in the MRI arm * To evaluate the accuracy of index lesion characteristics and other factors in predicting multi-centricity in the cohort randomized to breast MRI * To assess the positive predictive values (PPV) of MRI in detecting ipsilateral multi-centric disease and contralateral disease in women with breast cancer undergoing preoperative breast MRI * To estimate the false positive rate for detection of multiple foci of breast cancer by MRI All registered patients will be monitored for relapse and survival for 5 years from the date of surgery. Patients will be followed a minimum of every 4 months for the first 2 years from diagnosis and a minimum of every 6 months during years 3-5. Patients will be monitored for local, regional, distant relapse and vital status.

Interventions

PROCEDUREBreast surgery
PROCEDUREMagnetic resonance imaging
PROCEDUREMammography

Sponsors

Alliance for Clinical Trials in Oncology
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
American College of Radiology Imaging Network
CollaboratorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Female. Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer. * Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0). Diagnosis must be by needle biopsy; patients diagnosed by surgical excision are excluded. * Patients must have either: * Estrogen receptor (ER) negative/progesterone receptor (PR) negative (\< 10% by immunohistochemistry IHC staining) and HER-2 negative breast cancer OR * ER negative/PR negative (\< 10% by IHC staining) and HER-2 positive tumors * HER-2 status will be determined as per the 2013 ASCO CAP guidelines: * HER-2 is considered positive if there is IHC 3+ staining or ISH positive using either single probe ISH or dual probe ISH * HER-2 is considered negative if there is IHC 0 or 1+ staining or ISH negative using either single probe ISH or dual probe ISH * No patients with previous ipsilateral invasive breast cancer or ductal carcinoma in situ (DCIS) * No patients with bilateral breast cancer * No patients with known deleterious mutations in breast cancer (BRCA) genes * No current history of receiving hormonal therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures * No history of chemotherapy for cancer within 6 months prior to registration * No patients scheduled to receive neoadjuvant chemotherapy or partial breast irradiation following breast conserving surgery * Eligible for BCT based on clinical examination, mammography and, if standard practice at a given institution, ultrasound and/or tomogram. Women who cannot be appropriately selected for BCT based on these standard imaging studies, and for whom additional imaging is recommended to clarify local disease extent, will not be eligible for this trial. * No patients with multicentric or multifocal disease scheduled to undergo multiple lumpectomies. Multifocal disease that can be encompassed in a single operative bed can be enrolled. * Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow): * No history of untreatable claustrophobia * No presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants) * No history of sickle cell disease * No contraindication to intravenous contrast administration * No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance * No findings consistent with renal failure, as determined by glomerular filtration rate (GFR) \< 30 mL/min/1.73 m\^2 based on a creatinine level obtained within 28 days prior to registration * Weight lower than that allowable by the MRI table * No prior MRI of study breast within the 12 months prior to registration * Non-pregnant and non-lactating. Patients of child-bearing potential must have a negative pregnancy test within 7 days prior to registration. Perimenopausal patients must be amenorrheic \> 12 months to be considered not of child-bearing potential * ≥ 18 years of age * Signed study-specific informed consent prior to registration

Design outcomes

Primary

MeasureTime frame
Local-regional Recurrence (LRR)Up to 5 years

Secondary

MeasureTime frame
Re-operation RateUp to 5 years
Conversion Rate to Mastectomy Secondary to Persistent Positive Margins or Poor CosmesisWithin the first 6 months
Time to Contralateral Breast CancerUp to 5 years post-randomization
Disease-free Survival (DFS)Up to 5 years post-randomization
Overall SurvivalUp to 5 years post-randomization
Breast Cancer Specific Survival Will be MeasuredUp to 5 years post-randomization
Rate of MRI-guided Localization Assisted Surgery (Arm B)Up to 5 years
False Positive Rate for MRI Detection of Multiple Disease FociUp to 5 years

Countries

United States

Contacts

STUDY_CHAIRIsabelle Bedrosian, MD

M.D. Anderson Cancer Center

Baseline characteristics

Characteristic
Age, Continuous59 years
Axillary Surgery
ALND only
6 Participants
Axillary Surgery
Both
14 Participants
Axillary Surgery
Neither
4 Participants
Axillary Surgery
Patient did not have surgery
7 Participants
Axillary Surgery
SLN biopsy only
143 Participants
Clinical N stage
N0
151 Participants
Clinical N stage
N1
10 Participants
Clinical T stage
T1
230 Participants
Clinical T stage
T2
46 Participants
Clinical T stage
T3
2 Participants
Did patient get systemic chemo?
No
32 Participants
Did patient get systemic chemo?
Patient did not have surgery and did not have systemic chemo
7 Participants
Did patient get systemic chemo?
Yes
272 Participants
Did patient have adjuvant RT?
Missing
7 Participants
Did patient have adjuvant RT?
No
44 Participants
Did patient have adjuvant RT?
Yes
125 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
16 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
280 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
6 Participants
HER2 status
Negative
126 Participants
HER2 status
Positive
32 Participants
HER2 status
Unknown
1 Participants
Initial or Delayed Mastectomy
Delayed
4 Participants
Initial or Delayed Mastectomy
Initial
10 Participants
Initial or Delayed Mastectomy
Patient did not have mastectomy
137 Participants
Initial or Delayed Mastectomy
Patient did not have surgery
21 Participants
Margin Status
< 2mm
73 Participants
Margin Status
>= 2mm
205 Participants
Margin Status
Patient did not have surgery
21 Participants
Margin Status
Positive (tumor at surgical margin)
10 Participants
Mastectomy?
No
271 Participants
Mastectomy?
Patient did not have surgery
14 Participants
Mastectomy?
Yes
27 Participants
Mastectomy Side
Bilateral
14 Participants
Mastectomy Side
Patient did not have mastectomy
137 Participants
Mastectomy Side
Patient did not have surgery
14 Participants
Mastectomy Side
Unilateral
6 Participants
Max lesion size (cm)1.3 cm
Menopausal Status
Peri
6 Participants
Menopausal Status
Post
130 Participants
Menopausal Status
Pre
34 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
7 Participants
Race (NIH/OMB)
Black or African American
46 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
12 Participants
Race (NIH/OMB)
White
195 Participants
Receiving or recently completed neoadjuvant chemotherapy ?
No
130 Participants
Receiving or recently completed neoadjuvant chemotherapy ?
Yes
31 Participants
Reoperation?
No
129 Participants
Reoperation?
Patient did not have surgery
7 Participants
Reoperation?
Yes
14 Participants
Sex: Female, Male
Female
158 Participants
Sex: Female, Male
Male
0 Participants
Total number of lesions identified
1
140 Participants
Total number of lesions identified
2
25 Participants
Total number of lesions identified
3
2 Participants
Total number of lesions identified
4
2 Participants
Type of initial breast surgical procedure performed
Initial BCS
134 Participants
Type of initial breast surgical procedure performed
Initial bilateral mastectomy
9 Participants
Type of initial breast surgical procedure performed
Initial mastectomy
9 Participants
Type of initial breast surgical procedure performed
Patient did not have surgery
7 Participants
Was ultrasound performed?
Missing
7 Participants
Was ultrasound performed?
No
3 Participants
Was ultrasound performed?
Yes
148 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
13 / 15812 / 161
other
Total, other adverse events
26 / 15828 / 161
serious
Total, serious adverse events
0 / 1581 / 161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026