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Estrogen Receptor-negative Breast CancerPhase 3NCT01805076

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

A Phase 3 study testing Breast surgery, Magnetic resonance imaging and Mammography in people with Estrogen Receptor-negative Breast Cancer and Progesterone Receptor-negative Breast Cancer, run by Alliance for Clinical Trials in Oncology at 179 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Breast surgery, Magnetic resonance imaging and Mammography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
319 participants
Where
179 sitesUnited States
Study dates
21 May 2014to 27 May 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult
  • 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

Trial locations and contacts

179 sites in 1 country.

179 sites in 1 country

United States179 sites

  • McFarland Clinic PC - Ames

    Ames, Iowa, 50010

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • Fox Valley Surgical Associates Limited

    Appleton, Wisconsin, 54911

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • ThedaCare Regional Medical Center - Appleton

    Appleton, Wisconsin, 54911

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • IU Health West Hospital

    Avon, Indiana, 46123

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • IU Health North Hospital

    Carmel, Indiana, 46032

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Enloe Medical Center

    Chico, California, 95926

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Cookeville Regional Medical Center

    Cookeville, Tennessee, 38501

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Dekalb Medical Center

    Decatur, Georgia, 30033

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805

  • Parkview Regional Medical Center

    Fort Wayne, Indiana, 46845

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

  • Kaiser Permanente-Gaithersburg Medical Center

    Gaithersburg, Maryland, 20879

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Smilow Cancer Hospital Care Center - Guiford

    Guilford, Connecticut, 06437

  • Sentara Cancer Institute at Sentara CarePlex Hospital

    Hampton, Virginia, 23666

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    Jonesboro, Arkansas, 72401

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78041

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Holy Redeemer Hospital and Medical Center

    Meadowbrook, Pennsylvania, 19046

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Michiana Hematology Oncology PC-Mishawaka

    Mishawaka, Indiana, 46545

  • Kaiser Permanente-Modesto

    Modesto, California, 95356

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • The Community Hospital

    Munster, Indiana, 46321

  • Edward Hospital/Cancer Center

    Naperville, Illinois, 60540

  • Surgical Associates of Neenah SC

    Neenah, Wisconsin, 54956

  • Smilow Cancer Center/Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • Yale University

    New Haven, Connecticut, 06520

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Sentara Leigh Hospital

    Norfolk, Virginia, 23502

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473

  • Ascension Providence Hospitals - Novi

    Novi, Michigan, 48374

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Saint Joseph Hospital - Orange

    Orange, California, 92868

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Owensboro Health Mitchell Memorial Cancer Center

    Owensboro, Kentucky, 42303

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • Saint Joseph's Regional Medical Center

    Paterson, New Jersey, 07503

  • Capital Health Medical Center-Hopewell

    Pennington, New Jersey, 08534

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Edward Hospital/Cancer Center?Plainfield

    Plainfield, Illinois, 60585

  • Michiana Hematology Oncology PC-Plymouth

    Plymouth, Indiana, 46563

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Vassar Brothers Medical Center

    Poughkeepsie, New York, 12601

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Kaiser Permanente-Redwood City

    Redwood City, California, 94063

  • Kaiser Permanente-Richmond

    Richmond, California, 94801

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • Kaiser Permanente-Roseville

    Roseville, California, 95661

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Kaiser Permanente-South Sacramento

    Sacramento, California, 95823

  • Kaiser Permanente - Sacramento

    Sacramento, California, 95825

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Kaiser Permanente-San Francisco

    San Francisco, California, 94115

  • Kaiser Permanente-Santa Teresa-San Jose

    San Jose, California, 95119

  • Kaiser Permanente San Leandro

    San Leandro, California, 94577

  • Kaiser Permanente-San Rafael

    San Rafael, California, 94903

  • Kaiser San Rafael-Gallinas

    San Rafael, California, 94903

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

  • Kaiser Permanente-Santa Rosa

    Santa Rosa, California, 95403

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Michiana Hematology Oncology PC-South Bend

    South Bend, Indiana, 46601

  • South Jordan Health Center

    South Jordan, Utah, 84009

  • Kaiser Permanente-South San Francisco

    South San Francisco, California, 94080

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Kaiser Permanente-Stockton

    Stockton, California, 95210

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • Community Medical Center

    Toms River, New Jersey, 08755

  • William Beaumont Hospital - Troy

    Troy, Michigan, 48085

  • Smilow Cancer Hospital Care Center-Trumbull

    Trumbull, Connecticut, 06611

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Kaiser Permanente Medical Center-Vacaville

    Vacaville, California, 95688

  • Kaiser Permanente-Vallejo

    Vallejo, California, 94589

  • PeaceHealth Southwest Medical Center

    Vancouver, Washington, 98664

  • Kaiser Permanente-Walnut Creek

    Walnut Creek, California, 94596

  • Smilow Cancer Hospital Care Center - Waterford

    Waterford, Connecticut, 06385

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

  • Dickstein Cancer Treatment Center

    White Plains, New York, 10601

  • New Hanover Regional Medical Center/Zimmer Cancer Center

    Wilmington, North Carolina, 28401

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • UMass Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655

  • WellSpan Health-York Hospital

    York, Pennsylvania, 17403

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Breast surgery, Magnetic resonance imaging, Mammography
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breast surgeryProcedure or surgery

  • Magnetic resonance imagingProcedure or surgery

  • MammographyProcedure or surgery

Study groups in NCT01805076
Study groupRoleWhat they receive
Arm 1 (control)OtherPatients undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes followed by breast conserving surgery.
Receives: Procedure: Breast surgery; Procedure: Mammography
Arm 2 (experimental)ExperimentalPatients undergo a clinical breast examination, mammography with ultrasound of breast and regional nodes and breast MRI followed by breast conserving surgery or mastectomy.
Receives: Procedure: Breast surgery; Procedure: Magnetic resonance imaging; Procedure: Mammography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local-regional Recurrence (LRR)

    Measured: Up to 5 years

Secondary outcomes (8)

  1. Re-operation Rate

    Measured: Up to 5 years

  2. Conversion Rate to Mastectomy Secondary to Persistent Positive Margins or Poor Cosmesis

    Measured: Within the first 6 months

  3. Time to Contralateral Breast Cancer

    Measured: Up to 5 years post-randomization

  4. Disease-free Survival (DFS)

    Measured: Up to 5 years post-randomization

  5. Overall Survival

    Measured: Up to 5 years post-randomization

  6. Breast Cancer Specific Survival Will be Measured

    Measured: Up to 5 years post-randomization

  7. Rate of MRI-guided Localization Assisted Surgery (Arm B)

    Measured: Up to 5 years

  8. False Positive Rate for MRI Detection of Multiple Disease Foci

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2013 (estimated)
  2. Study start21 May 2014
  3. Primary completion27 May 2025
  4. Study completion27 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01805076
Sponsor's protocol ID
A011104
Other IDs
ACRIN 6694, U10CA037447, NCI-2012-02045
Status last verified
Jun 2026
First submitted
24 Feb 2013
Last updated
26 Jun 2026
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Breast surgery, Magnetic resonance imaging and Mammography in people with Estrogen Receptor-negative Breast Cancer and Progesterone Receptor-negative Breast Cancer, run by Alliance for Clinical Trials in Oncology at 179 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 179 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local-regional Recurrence (LRR) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01805076.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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