Invasive Breast CarcinomaPhase 2NCT03188393
Assessing the Accuracy of Tumor Biopsies After Chemotherapy to Determine if Patients Can Avoid Breast Surgery
A Phase 2 study testing Biopsy of Breast in people with Invasive Breast Carcinoma and Stage II Breast Cancer, run by NRG Oncology at 381 sites in 2 countries.
Trial summary
This phase II trial studies how well biopsy of breast after chemotherapy works in predicting pathologic response in patients with stage II-IIIA breast cancer undergoing breast conserving surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Breast Carcinoma, Stage II Breast Cancer, Stage IIA Breast Cancer
- What is being tested?
- Biopsy of Breast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 381 sitesin 2 countries
- Study dates
- 13 Apr 2017to 1 Dec 2022
- Phase
- Phase 2
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
- The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients must have had ER analysis performed on the primary breast tumor collected prior to neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP Guideline Recommendations for hormone receptor testing. Patients who have a primary tumor that is hormone receptor-positive or hormone receptor-negative are eligible.
- Patients must have had HER2 testing performed on the primary breast tumor collected prior to neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer; patients who have a primary tumor that is HER2-positive, HER2-equivocal, or HER2-negative are eligible
- Patients must have had a biopsy marker placed within the tumor bed with imaging confirmation (preferably mammogram but ultrasound or magnetic resonance imaging [MRI] is acceptable) of marker placement prior to neoadjuvant chemotherapy
- Patients with operable focal or multifocal (T1-T3, stage II or III invasive ductal carcinoma [all receptor phenotypes]), and who have completed neoadjuvant chemotherapy with a clinical complete response (by clinical examination)
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- Patients with synchronous bilateral breast cancer are eligible if at least one of the synchronous breast cancers has a cCR, and the side with a cCR meets criteria. (Patients with previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible.)
- Patients must have achieved a complete or near complete radiologic tumor response on breast imaging with mammogram, ultrasound, and MRI during or after completion of appropriate neoadjuvant chemotherapy defined as:
- Mammogram with malignant appearing calcification or mass ≤ 1 cm; or
- Ultrasound with a hypoechoic area ≤ 2 cm; or
- Breast MRI not demonstrating a residual mass with rapid rise and washout type III kinetics.
- At the time of consent, the patient's intent must be to undergo breast conserving therapy.
- Patient must be able to undergo stereotactic-vacuum-assisted breast biopsy with clip placement after completion of neoadjuvant chemotherapy. (The patient must be enrolled on the study before performing the post-neoadjuvant stereotactic-vacuum-assisted breast biopsy.)
- Patient must have completed neoadjuvant chemotherapy.
- Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated.
- Patients treated with PD-1 or PD-L1 inhibitors, CDK 4/6 inhibitors, or other immune-based therapy are eligible.
Who cannot join
- T4 tumors including inflammatory breast cancer
- Patients with distant metastatic disease
- Lumpectomy performed prior to study entry
- Patients with any history of prior radiation therapy in the affected breast
- Patients with a prior history of ipsilateral invasive breast cancer; (patients with previous ipsilateral/contralateral DCIS or previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible)
- Patients with invasive lobular carcinoma
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- Patients who have multicentric disease
- Patients treated with neoadjuvant hormonal therapy only are not eligible
- Patients who are medically unfit to undergo surgical resection
- Patients without breast biopsy marker documented by imaging at tumor bed site prior to initiation of neoadjuvant therapy
- Patients with one or more of the following imaging criteria from any of the 3 imaging modalities after completion of NCT demonstrating incomplete radiologic response are not eligible:
- Mammogram with malignant appearing calcifications or mass > 1 cm; or
- Ultrasound with a hypoechoic area > 2 cm; or
- Breast MRI demonstrating a residual mass with rapid rise and washout type III kinetics.
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results
- Pregnancy or lactation at the time of study registration; (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to study registration.)
Trial locations and contacts
381 sites in 2 countries.
304 sites in 2 countries
United States300 sites
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 96701
Jefferson Abington Hospital
Abington, Pennsylvania, 19001
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
Community Hospital of Anaconda
Anaconda, Montana, 59711
Anne Arundel Medical Center
Annapolis, Maryland, 21401
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Piedmont Hospital
Atlanta, Georgia, 30309
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
John Fitzgerald Kennedy Medical Center
Atlantis, Florida, 33462
Sutter Auburn Faith Hospital
Auburn, California, 95602
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
University of Colorado Hospital
Aurora, Colorado, 80045
Rush - Copley Medical Center
Aurora, Illinois, 60504
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, 97814
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
Billings Clinic Cancer Center
Billings, Montana, 59101
Saint Vincent Healthcare
Billings, Montana, 59101
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Boulder Community Hospital
Boulder, Colorado, 80301
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Cox Cancer Center Branson
Branson, Missouri, 65616
United Hospital Center
Bridgeport, West Virginia, 26330
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Roswell Park Cancer Institute
Buffalo, New York, 14263
Mills-Peninsula Medical Center
Burlingame, California, 94010
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Cambridge Medical Center
Cambridge, Minnesota, 55008
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682
Eden Hospital Medical Center
Castro Valley, California, 94546
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina, 28210
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001
Northwestern University
Chicago, Illinois, 60611
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Case Western Reserve University
Cleveland, Ohio, 44106
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Billings Clinic-Cody
Cody, Wyoming, 82414
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Coffeyville Regional Medical Center
Coffeyville, Kansas, 67337
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Mercy Hospital
Coon Rapids, Minnesota, 55433
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Carle at The Riverfront
Danville, Illinois, 61832
Sutter Davis Hospital
Davis, California, 95616
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
Dekalb Medical Center
Decatur, Georgia, 30033
Denver Health Medical Center
Denver, Colorado, 80204
National Jewish Health-Main Campus
Denver, Colorado, 80206
The Women's Imaging Center
Denver, Colorado, 80209
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
SCL Health Saint Joseph Hospital
Denver, Colorado, 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
Rose Medical Center
Denver, Colorado, 80220
Western Surgical Care
Denver, Colorado, 80220
Henry Ford Hospital
Detroit, Michigan, 48202
Epic Care-Dublin
Dublin, California, 94568
Duke University Medical Center
Durham, North Carolina, 27710
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Fairview Southdale Hospital
Edina, Minnesota, 55435
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Wake Forest University at Elkin
Elkin, North Carolina, 28521
Bay Area Breast Surgeons Inc
Emeryville, California, 94608
Epic Care Partners in Cancer Care
Emeryville, California, 94608
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113
Swedish Medical Center
Englewood, Colorado, 80113
Ephrata Cancer Center
Ephrata, Pennsylvania, 17522
Ephrata Community Hospital
Ephrata, Pennsylvania, 17522
Deaconess Clinic Downtown
Evansville, Indiana, 47713
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Farmington Health Center
Farmington, Utah, 84025
Piedmont Fayette Hospital
Fayetteville, Georgia, 30214
Aurora Health Center-Fond du Lac
Fond du Lac, Wisconsin, 54937
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805
Parkview Regional Medical Center
Fort Wayne, Indiana, 46845
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee, 37067
Kaiser Permanente-Fremont
Fremont, California, 94538
Palo Alto Medical Foundation-Fremont
Fremont, California, 94538
Fresno Cancer Center
Fresno, California, 93720
Kaiser Permanente-Fresno
Fresno, California, 93720
Unity Hospital
Fridley, Minnesota, 55432
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Adams Cancer Center
Gettysburg, Pennsylvania, 17325
National Jewish Health-Western Hematology Oncology
Golden, Colorado, 80401
Goshen Center for Cancer Care
Goshen, Indiana, 46526
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501
Grand Valley Oncology
Grand Junction, Colorado, 81505
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405
Great Falls Clinic
Great Falls, Montana, 59405
North Colorado Medical Center
Greeley, Colorado, 80631
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
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
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, 08690
Sentara Cancer Institute at Sentara CarePlex Hospital
Hampton, Virginia, 23666
Cherry Tree Cancer Center
Hanover, Pennsylvania, 17331
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, 17101
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109
HaysMed University of Kansas Health System
Hays, Kansas, 67601
Saint Peter's Community Hospital
Helena, Montana, 59601
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
Island Urology
Honolulu, Hawaii, 96813
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
Queen's Medical Center
Honolulu, Hawaii, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, 96817
Kuakini Medical Center
Honolulu, Hawaii, 96817
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Houston Methodist Hospital
Houston, Texas, 77030
M D Anderson Cancer Center
Houston, Texas, 77030
Centerpoint Medical Center LLC
Independence, Missouri, 64057
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Allegiance Health
Jackson, Michigan, 49201
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901
Freeman Health System
Joplin, Missouri, 64804
Mercy Hospital Joplin
Joplin, Missouri, 64804
Kalispell Regional Medical Center
Kalispell, Montana, 59901
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Truman Medical Centers
Kansas City, Missouri, 64108
The University of Kansas Cancer Center-South
Kansas City, Missouri, 64131
Research Medical Center
Kansas City, Missouri, 64132
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Good Samaritan Medical Center
Lafayette, Colorado, 80026
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Doctor's Hospital of Laredo
Laredo, Texas, 78041
Sechler Family Cancer Center
Lebanon, Pennsylvania, 17042
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
Kansas Institute of Medicine Cancer and Blood Center
Lenexa, Kansas, 66219
Minimally Invasive Surgery Hospital
Lenexa, Kansas, 66219
Beebe Medical Center
Lewes, Delaware, 19958
Wake Forest University at Lexington
Lexington, North Carolina, 27292
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124
Los Angeles County-USC Medical Center
Los Angeles, California, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
McKee Medical Center
Loveland, Colorado, 80539
Medical Center of Central Georgia
Macon, Georgia, 31201
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
Contra Costa Regional Medical Center
Martinez, California, 94553-3156
WVUH-Berkely Medical Center
Martinsburg, West Virginia, 25401
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Loyola University Medical Center
Maywood, Illinois, 60153
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, 15132
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, 60160
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Health Partners Inc
Minneapolis, Minnesota, 55454
Community Medical Hospital
Missoula, Montana, 59804
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36688
Memorial Medical Center
Modesto, California, 95355
Kaiser Permanente-Modesto
Modesto, California, 95356
Trinity Medical Center
Moline, Illinois, 61265
Atrium Health Union/LCI-Union
Monroe, North Carolina, 28112
Monticello Cancer Center
Monticello, Minnesota, 55362
UPMC Hillman Cancer Center in Coraopolis
Moon Township, Pennsylvania, 15108
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Wake Forest University at Mount Airy
Mount Airy, North Carolina, 27030
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, 94040
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, 37204
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510
Yale University
New Haven, Connecticut, 06520
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
New Ulm Medical Center
New Ulm, Minnesota, 56073
Mount Sinai Union Square
New York, New York, 10003
Mount Sinai West
New York, New York, 10019
Mount Sinai Hospital
New York, New York, 10029
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, 19713
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Chancellor Center for Oncology
Newburgh, Indiana, 47630
Sentara Leigh Hospital
Norfolk, Virginia, 23502
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Sutter Cancer Research Consortium
Novato, California, 94945
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609
Bay Area Tumor Institute
Oakland, California, 94609
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611
Kaiser Permanente-Oakland
Oakland, California, 94611
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
Olathe Health Cancer Center
Olathe, Kansas, 66061
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon, 97914
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462
Orlando Health Cancer Institute
Orlando, Florida, 32806
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
Menorah Medical Center
Overland Park, Kansas, 66209
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
Camden Clark Medical Center
Parkersburg, West Virginia, 26101
Keck Medical Center of USC Pasadena
Pasadena, California, 91105
Memorial Hospital West
Pembroke Pines, Florida, 33028
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
Ascension Via Christi - Pittsburg
Pittsburg, Kansas, 66762
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, 15215
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Women and Infants Hospital
Providence, Rhode Island, 02905
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670
Kaiser Permanente-Redwood City
Redwood City, California, 94063
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Kaiser Permanente-Richmond
Richmond, California, 94801
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Rohnert Park Cancer Center
Rohnert Park, California, 94928
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
Kaiser Permanente-Roseville
Roseville, California, 95661
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661
Sutter Roseville Medical Center
Roseville, California, 95661
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678
Scott and White Healthcare Round Rock
Round Rock, Texas, 78665
Kaiser Permanente Downtown Commons
Sacramento, California, 95814
Sutter Medical Center Sacramento
Sacramento, California, 95816
Kaiser Permanente-South Sacramento
Sacramento, California, 95823
South Sacramento Cancer Center
Sacramento, California, 95823
Kaiser Permanente - Sacramento
Sacramento, California, 95825
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Regions Hospital
Saint Paul, Minnesota, 55101
United Hospital
Saint Paul, Minnesota, 55102
Salina Regional Health Center
Salina, Kansas, 67401
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Naval Medical Center -San Diego
San Diego, California, 92134
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115
Kaiser Permanente-San Francisco
San Francisco, California, 94115
Canada4 sites
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, H3H 2R9
Jewish General Hospital
Montreal, Quebec, H3T 1E2
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase II Trial Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response in Patients With Clinical/Radiologic Complete Response After Neoadjuvant Chemotherapy in Order to Explore the Feasibility of Breast Conserving Treatment Without Surgery
This phase II trial studies how well biopsy of breast after chemotherapy works in predicting pathologic response in patients with stage II-IIIA breast cancer undergoing breast conserving surgery. Tumor tissue collected from biopsy before surgery may help to check if chemotherapy destroyed the breast cancer cells and may be compared to the tumor removed during surgery to check if they are the same.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the accuracy of post-neoadjuvant systemic therapy (NST) image-directed tumor bed biopsy for pathologic complete response (pCR), defined as resolution of both invasive disease and ductal carcinoma in situ (DCIS), in cases of clinical and radiologic complete response with trimodality imaging.
SECONDARY OBJECTIVES:
- To collect axillary pathology results, surgical staging methods (sentinel lymph node biopsy and/or axillary lymph node dissection), and management (surgery and/or radiation) in order to determine axillary nodal response to neoadjuvant chemotherapy and its relationship to breast pCR.
II. To correlate imaging results with pathologic nodal status following neoadjuvant chemotherapy for future planning of axillary management in the next study.
III. To retrospectively assess the negative predictive value (NPV) of a trimodality imaging algorithm in combination with the tumor bed biopsy for predicting pCR.
IV. To collect all trimodality imaging data to determine which combination of the trimodality imaging best identifies the group achieving pCR.
- To correlate the number of needle cores and tumor bed clip retrieval with the NPV of the tumor site biopsy.
VI. To determine the clinical, imaging, pathologic, and molecular tumor factors associated with the highest NPVs of post-NST tumor bed biopsies.
VII. To improve identification and selection of patients with breast and possible axillary pCR for future trial planning, routine biomarkers (estrogen receptor [ER], progesterone receptor [PR], HER2 neu, and Ki67) will be collected to allow comparison to image/clinical complete response (CR), and tumor bed biopsies.
OUTLINE:
After completion of neoadjuvant therapy, patients undergo stereotactic biopsy of breast tumor any time prior to breast conserving surgery. Patients then undergo breast conserving surgery as per standard of care. Patients may also undergo postoperative radiation therapy per standard of care or adjuvant therapy at the investigator's discretion.
- Conditions
- Invasive Breast Carcinoma, Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer
- Being tested
- Biopsy of Breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy of BreastProcedure or surgery
Also called Breast Biopsy
Undergo stereotactic biopsy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (biopsy of breast) | Experimental | After completion of neoadjuvant therapy, patients undergo stereotactic biopsy of breast tumor any time prior to breast conserving surgery. Patients then undergo breast conserving surgery as per standard of care. Patients may also undergo postoperative radiation therapy per standard of care or adjuvant therapy at the investigator's discretion. Receives: Procedure: Biopsy of Breast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with pCR
The proportion of tumor bed biopsies that are negative among those who are shown to have pCR at surgery will be determined. The point estimate and 95% confidence interval will be calculated.
Measured: Up to 18 months
Secondary outcomes (6)
Improvement of negative predictive value
Analysis will be performed to assess the improvement in the negative predictive value of the trimodality imaging algorithm when the results of tumor bed biopsy are added.
Measured: Up to 18 months
Incidence of adverse events associated with tumor bed biopsy
Descriptive analysis will be performed to determine the frequencies of adverse events associated with tumor bed biopsy.
Measured: Up to 18 months
Number of needle cores performed
Descriptive analysis will be performed to determine the distribution of the number of needle cores performed and the proportion of clips retrieved.
Measured: Up to 18 months
Proportion of clips retrieved
Descriptive analysis will be performed.
Measured: Up to 18 months
Residual cancer burden score
Descriptive analysis will be performed to determine the distribution of residual cancer burden score.
Measured: Up to 18 months
Trimodality imaging algorithm +/- biopsy as a predictor of pCR
Analysis will be performed to assess the improvement in the negative predictive value of the trimodality imaging algorithm when the results of tumor bed biopsy are added.
Measured: Up to18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start13 Apr 2017
- Primary completion5 Jul 2019
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Invasive Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by NRG OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- NRG Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mark Basik, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188393
- Sponsor's protocol ID
- NRG-BR005
- Other IDs
- NCI-2016-01825, NRG-BR005, NRG-BR005, NRG-BR005, U10CA180868
- Status last verified
- May 2025
- First submitted
- 13 Jun 2017
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Basik M, Cecchini RS, De Los Santos JF, Umphrey HR, Julian TB, Mamounas EP, White JR, Lucas PC, Balanoff CR, Tan AR, Weber JJ, Edmonson DA, Brown-Glaberman UA, Diego EJ, Teshome M, Matsen CB, Seaward SA, Wapnir IL, Wagner JL, Tjoe JA, Thompson AM, Wolmark N. Breast Tumor-Bed Biopsy for Pathological Complete Response Prediction: The NRG-BR005 Nonrandomized Clinical Trial. JAMA Surg. 2025 Jul 1;160(7):723-731. doi: 10.1001/jamasurg.2025.1072.
PubMed 40332918Gharzai LA, Szczygiel LA, Shumway DA, Bandos H, Julian TB, Mamounas EP, White J, De Los Santos JF, Basik M, Ganz PA, Jagsi R. A qualitative study to evaluate physician attitudes regarding omission of surgery among exceptional responders to neoadjuvant systemic therapy for breast cancer (NRG-CC006). Breast Cancer Res Treat. 2021 Jun;187(3):777-784. doi: 10.1007/s10549-021-06172-0. Epub 2021 Mar 19.
PubMed 33740205