Assessing the Accuracy of Tumor Biopsies After Chemotherapy to Determine if Patients Can Avoid Breast Surgery
Invasive Breast Carcinoma, Stage II Breast Cancer, Stage IIA Breast Cancer

About this trial
This is an interventional other trial for Invasive Breast Carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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)
- 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.
Exclusion Criteria:
- 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
- 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.)
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- University of South Alabama Mitchell Cancer Institute
- Cancer Center at Saint Joseph's
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- Mercy Hospital Fort Smith
- Kaiser Permanente-Deer Valley Medical Center
- Sutter Auburn Faith Hospital
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Alta Bates Summit Medical Center-Herrick Campus
- Mills-Peninsula Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Eden Hospital Medical Center
- Sutter Davis Hospital
- Epic Care-Dublin
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Kaiser Permanente-Fremont
- Palo Alto Medical Foundation-Fremont
- Fresno Cancer Center
- Kaiser Permanente-Fresno
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Contra Costa Regional Medical Center
- Memorial Medical Center
- Kaiser Permanente-Modesto
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Sutter Cancer Research Consortium
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Kaiser Permanente Oakland-Broadway
- Kaiser Permanente-Oakland
- Palo Alto Medical Foundation Health Care
- Stanford Cancer Institute Palo Alto
- Keck Medical Center of USC Pasadena
- Kaiser Permanente-Rancho Cordova Cancer Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Rohnert Park Cancer Center
- Kaiser Permanente-Roseville
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- The Permanente Medical Group-Roseville Radiation Oncology
- Kaiser Permanente Downtown Commons
- Sutter Medical Center Sacramento
- Kaiser Permanente-South Sacramento
- South Sacramento Cancer Center
- Kaiser Permanente - Sacramento
- Naval Medical Center -San Diego
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Kaiser Permanente-San Rafael
- Kaiser San Rafael-Gallinas
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Kaiser Permanente-Santa Rosa
- Sutter Pacific Medical Foundation
- Kaiser Permanente Cancer Treatment Center
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Palo Alto Medical Foundation-Sunnyvale
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut Creek
- Epic Care Cyberknife Center
- Rocky Mountain Cancer Centers-Aurora
- University of Colorado Hospital
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Denver Health Medical Center
- National Jewish Health-Main Campus
- The Women's Imaging Center
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Western Surgical Care
- Mountain Blue Cancer Care Center - Swedish
- Swedish Medical Center
- Poudre Valley Hospital
- National Jewish Health-Western Hematology Oncology
- Saint Mary's Hospital and Regional Medical Center
- Grand Valley Oncology
- North Colorado Medical Center
- Good Samaritan Medical Center
- Rocky Mountain Cancer Centers-Littleton
- Rocky Mountain Cancer Centers-Sky Ridge
- McKee Medical Center
- National Jewish Health-Northern Hematology Oncology
- SCL Health Lutheran Medical Center
- Smilow Cancer Center/Yale-New Haven Hospital
- Yale University
- Beebe Medical Center
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- TidalHealth Nanticoke / Allen Cancer Center
- Christiana Care Health System-Wilmington Hospital
- John Fitzgerald Kennedy Medical Center
- University of Florida Health Science Center - Gainesville
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
- Orlando Health Cancer Institute
- Memorial Hospital West
- Emory University Hospital Midtown
- Piedmont Hospital
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- Dekalb Medical Center
- Piedmont Fayette Hospital
- Medical Center of Central Georgia
- Hawaii Cancer Care - Westridge
- Pali Momi Medical Center
- Queen's Cancer Center - Pearlridge
- The Cancer Center of Hawaii-Pali Momi
- Hawaii Cancer Care Inc - Waterfront Plaza
- Island Urology
- Queen's Cancer Cenrer - POB I
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Kuakini Medical Center
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and Children
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Health - Coeur d'Alene
- Walter Knox Memorial Hospital
- Idaho Urologic Institute-Meridian
- Saint Alphonsus Cancer Care Center-Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Kootenai Cancer Clinic
- Rush - Copley Medical Center
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- Rush University Medical Center
- University of Chicago Comprehensive Cancer Center
- Carle at The Riverfront
- Carle Physician Group-Effingham
- Northwestern Medicine Lake Forest Hospital
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Marjorie Weinberg Cancer Center at Loyola-Gottlieb
- Trinity Medical Center
- Good Samaritan Regional Health Center
- UC Comprehensive Cancer Center at Silver Cross
- University of Chicago Medicine-Orland Park
- Carle Cancer Center
- The Carle Foundation Hospital
- Rush-Copley Healthcare Center
- Deaconess Clinic Downtown
- Parkview Hospital Randallia
- Parkview Regional Medical Center
- Goshen Center for Cancer Care
- Chancellor Center for Oncology
- University of Iowa/Holden Comprehensive Cancer Center
- Coffeyville Regional Medical Center
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- HaysMed University of Kansas Health System
- University of Kansas Cancer Center
- Kansas Institute of Medicine Cancer and Blood Center
- Minimally Invasive Surgery Hospital
- Olathe Health Cancer Center
- Menorah Medical Center
- University of Kansas Cancer Center-Overland Park
- University of Kansas Hospital-Indian Creek Campus
- Ascension Via Christi - Pittsburg
- Salina Regional Health Center
- University of Kansas Health System Saint Francis Campus
- University of Kansas Hospital-Westwood Cancer Center
- Louisiana State University Health Science Center
- University Medical Center New Orleans
- Anne Arundel Medical Center
- Greater Baltimore Medical Center
- UM Upper Chesapeake Medical Center
- Lahey Hospital and Medical Center
- Winchester Hospital
- Henry Ford Cancer Institute-Downriver
- Henry Ford Macomb Hospital-Clinton Township
- Henry Ford Medical Center-Fairlane
- Henry Ford Hospital
- Allegiance Health
- Henry Ford Medical Center-Columbus
- Henry Ford West Bloomfield Hospital
- Sanford Joe Lueken Cancer Center
- Fairview Ridges Hospital
- Cambridge Medical Center
- Mercy Hospital
- Fairview Southdale Hospital
- Unity Hospital
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- Monticello Cancer Center
- New Ulm Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Fairview Lakes Medical Center
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - Bolivar
- Cox Cancer Center Branson
- Siteman Cancer Center at West County Hospital
- Centerpoint Medical Center LLC
- Freeman Health System
- Mercy Hospital Joplin
- Truman Medical Centers
- The University of Kansas Cancer Center-South
- Research Medical Center
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Mercy Hospital South
- Siteman Cancer Center-South County
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Mercy Hospital Washington
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Community Medical Hospital
- The Cancer Institute of New Jersey Hamilton
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
- Rutgers Cancer Institute of New Jersey
- University of New Mexico Cancer Center
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- Roswell Park Cancer Institute
- Mount Sinai Union Square
- Mount Sinai West
- Mount Sinai Hospital
- State University of New York Upstate Medical University
- SUNY Upstate Medical Center-Community Campus
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Atrium Health Pineville/LCI-Pineville
- Duke University Medical Center
- Wake Forest University at Elkin
- Wake Forest University at Lexington
- Atrium Health Union/LCI-Union
- Wake Forest University at Mount Airy
- Wake Forest University Health Sciences
- Sanford Bismarck Medical Center
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- UHHS-Chagrin Highlands Medical Center
- Case Western Reserve University
- Ohio State University Comprehensive Cancer Center
- UH Seidman Cancer Center at Saint John Medical Center
- UHHS-Westlake Medical Center
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Saint Alphonsus Medical Center-Baker City
- Saint Alphonsus Medical Center-Ontario
- Jefferson Abington Hospital
- UPMC-Heritage Valley Health System Beaver
- Christiana Care Health System-Concord Health Center
- Ephrata Cancer Center
- Ephrata Community Hospital
- Adams Cancer Center
- UPMC Cancer Centers - Arnold Palmer Pavilion
- Cherry Tree Cancer Center
- UPMC Pinnacle Harrisburg
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
- Sechler Family Cancer Center
- UPMC Cancer Center at UPMC McKeesport
- UPMC Hillman Cancer Center in Coraopolis
- Allegheny General Hospital
- UPMC-Magee Womens Hospital
- UPMC-Presbyterian Hospital
- UPMC-Saint Margaret
- University of Pittsburgh Cancer Institute (UPCI)
- UPMC-Shadyside Hospital
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- UPMC Cancer Center at UPMC Northwest
- UPMC Uniontown Hospital Radiation Oncology
- UPMC Washington Hospital Radiation Oncology
- Reading Hospital
- Wexford Health and Wellness Pavilion
- WellSpan Health-York Cancer Center
- WellSpan Health-York Hospital
- Women and Infants Hospital
- Prisma Health Cancer Institute - Spartanburg
- Prisma Health Cancer Institute - Easley
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Prisma Health Cancer Institute - Seneca
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Vanderbilt-Ingram Cancer Center Cool Springs
- Baptist Memorial Hospital and Cancer Center-Memphis
- Vanderbilt Breast Center at One Hundred Oaks
- Vanderbilt University/Ingram Cancer Center
- Houston Methodist Hospital
- M D Anderson Cancer Center
- Doctor's Hospital of Laredo
- Scott and White Healthcare Round Rock
- Houston Methodist Sugar Land Hospital
- Scott and White Memorial Hospital
- Farmington Health Center
- Huntsman Cancer Institute/University of Utah
- South Jordan Health Center
- Sentara Cancer Institute at Sentara CarePlex Hospital
- Sentara Leigh Hospital
- Sentara Norfolk General Hospital
- Virginia Commonwealth University/Massey Cancer Center
- Sentara Virginia Beach General Hospital
- Sentara Princess Anne Hospital
- United Hospital Center
- WVUH-Berkely Medical Center
- West Virginia University Healthcare
- Camden Clark Medical Center
- Aurora Cancer Care-Southern Lakes VLCC
- Aurora Health Center-Fond du Lac
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Aurora BayCare Medical Center
- Aurora Cancer Care-Kenosha South
- Aurora Bay Area Medical Group-Marinette
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Aurora Sinai Medical Center
- Cancer Center of Western Wisconsin
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Vince Lombardi Cancer Clinic-Sheboygan
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Cheyenne Regional Medical Center-West
- Billings Clinic-Cody
- Welch Cancer Center
- University Health Network-Princess Margaret Hospital
- CHUM - Centre Hospitalier de l'Universite de Montreal
- The Research Institute of the McGill University Health Centre (MUHC)
- Jewish General Hospital
Arms of the Study
Arm 1
Experimental
Diagnostic (biopsy of breast)
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.