Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer (HERO)
HER2-positive Breast Cancer
About this trial
This is an interventional treatment trial for HER2-positive Breast Cancer
Eligibility Criteria
Inclusion Criteria: The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information. female and male patients who have undergone breast conserving surgery and completed a minimum of 4 cycles (12 weeks) of neoadjuvant or adjuvant chemotherapy in combination with HER2-targeted therapy. -≥ 40 years of age ECOG performance status of 0 ,1, or 2/Karnofsky performance status above 60 Histologically or cytologically confirmed invasive breast carcinoma. tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results. Patient must have undergone axillary staging, either sentinel node biopsy (SNB) or axillary lymph nodal dissection (ALND). In neoadjuvant patients, SNB following neoadjuvant therapy is strongly recommended. SNB prior to neoadjuvant therapy is discouraged, but patients are permitted if node negative (pN0). The following staging criteria must be met according to AJCC 8th edition criteria: Adjuvant cohort : By pathologic evaluation, the patient's primary tumor must be </= 2 cm and ipsilateral nodes must be pN0. Surgical lumpectomy margins must be negative for invasive cancer and ductal carcinoma in situ (no ink on tumor). Neoadjuvant cohort: Prior to neoadjuvant therapy, the patient's primary tumor must be < 3 cm by imaging studies, with negative axillary nodes (cN0) based on axillary U/S, CT, PET or MRI. Physical examination is not sufficient documentation of cN0 status; • Must be ypT0N0 at surgery (lumpectomy); patients with residual non-invasive disease (DCIS) in the surgical specimen (ypTis), are NOT eligible. For the Adjuvant cohort, adjuvant therapy must have consisted of a minimum of 4 cycles (12 weeks) of chemotherapy in combination with HER2-targeted therapy. For the Neoadjuvant cohort, neoadjuvant therapy must have consisted of a minimum of 4 cycles (12 weeks) of chemotherapy in combination with HER2-targeted therapy.- ; Patients who did not receive chemotherapy in the neoadjuvant setting are not eligible, even if they achieved pCR with their preoperative treatment; nor would these patients become eligible by receiving chemotherapy after surgery. In patients assigned to radiation therapy, treatment should start ≤ 12 weeks from surgery on the Neoadjuvant cohort and ≤ 8 weeks from the completion of chemotherapy on the Adjuvant cohort. Patients should continue HER2-targeted therapy during assigned study treatment (radiation or observation). Bilateral mammogram or MRI within 52 weeks prior to randomization. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. Exclusion Criteria: Definitive clinical or radiologic evidence of metastatic disease. On the Adjuvant cohort, patients with a primary tumor >2 cm on pathologic examination of the surgical specimen. On the Neoadjuvant cohort, patients with a primary tumor > 3 cm or with abnormal or suspicious ipsilateral axillary nodes by pretreatment imaging, unless demonstrated to be negative by cytologic or histologic examination. Pathologically positive axillary nodes at any time including of pN0(i+) or pN0(mol+) ypN0(i+) or ypN0(mol+) disease. Patient planning for or status-post mastectomy. Radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary lymph nodes, unless there is histological confirmation that these nodes are negative for metastatic disease. Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast), or mass or non-mass enhancement on MRI (if performed) aside from the known cancer, unless biopsied and found to be benign. Non-epithelial breast malignancies such as sarcoma or lymphoma. Multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by > 4 centimeters. If multifocal, all foci should be confined to a maximum tumor bed of 3 cm determined by pathological assessment. Paget's disease of the nipple. Synchronous (unilateral or bilateral) invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible.) On the Adjuvant cohort, surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible). Treatment plan that includes regional nodal irradiation. Patients treated for a prior invasive breast malignancy are excluded. Contralateral DCIS ≥ 10 years prior to enrollment is permissible. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Patients on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible unless discontinued prior to randomization. Prior ipsilateral breast or thoracic RT for any condition (contralateral RT for DCIS ≥ 10 years prior to randomization is permitted). Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active systemic lupus erythematosus, or scleroderma. Clinicians should consider whether any conditions would make this protocol unreasonably hazardous for the patient. Pregnancy or lactation at the time of randomization or intention to become pregnant during treatment. (Note: Pregnancy testing according to institutional standards for patients of childbearing potential must be performed within 14 days prior to randomization.) Use of any investigational product within 30 days prior to randomization.
Sites / Locations
- Banner University Medical Center - TucsonRecruiting
- University of Arizona Cancer Center-North CampusRecruiting
- Kaiser Permanente-Deer Valley Medical CenterRecruiting
- Mission Hope Medical Oncology - Arroyo GrandeRecruiting
- Kaiser Permanente DublinRecruiting
- Kaiser Permanente-FremontRecruiting
- Fresno Cancer CenterRecruiting
- Kaiser Permanente-FresnoRecruiting
- Los Angeles County-USC Medical CenterRecruiting
- USC / Norris Comprehensive Cancer CenterRecruiting
- Kaiser Permanente-ModestoRecruiting
- Kaiser Permanente Oakland-BroadwayRecruiting
- Kaiser Permanente-OaklandRecruiting
- UC Irvine Health/Chao Family Comprehensive Cancer CenterRecruiting
- Stanford Cancer Institute Palo AltoRecruiting
- Pomona Valley Hospital Medical CenterRecruiting
- Kaiser Permanente-Rancho Cordova Cancer CenterRecruiting
- Kaiser Permanente- Marshall Medical OfficesRecruiting
- Kaiser Permanente-RichmondRecruiting
- Rohnert Park Cancer CenterRecruiting
- Kaiser Permanente-RosevilleRecruiting
- The Permanente Medical Group-Roseville Radiation OncologyRecruiting
- Kaiser Permanente Downtown CommonsRecruiting
- Kaiser Permanente-South SacramentoRecruiting
- South Sacramento Cancer CenterRecruiting
- Kaiser Permanente-San FranciscoRecruiting
- Kaiser Permanente-Santa Teresa-San JoseRecruiting
- Stanford Cancer Center South BayRecruiting
- Kaiser Permanente San LeandroRecruiting
- Pacific Central Coast Health Center-San Luis ObispoRecruiting
- Kaiser San Rafael-GallinasRecruiting
- Ridley-Tree Cancer CenterRecruiting
- Kaiser Permanente Medical Center - Santa ClaraRecruiting
- Mission Hope Medical Oncology - Santa MariaRecruiting
- Kaiser Permanente-Santa RosaRecruiting
- Kaiser Permanente Cancer Treatment CenterRecruiting
- Kaiser Permanente-South San FranciscoRecruiting
- Kaiser Permanente-StocktonRecruiting
- Kaiser Permanente Medical Center-VacavilleRecruiting
- Kaiser Permanente-VallejoRecruiting
- Kaiser Permanente-Walnut CreekRecruiting
- UCHealth University of Colorado HospitalRecruiting
- Rocky Mountain Cancer Centers-PenroseRecruiting
- UCHealth Memorial Hospital CentralRecruiting
- Memorial Hospital NorthRecruiting
- Poudre Valley HospitalRecruiting
- Cancer Care and Hematology-Fort CollinsRecruiting
- UCHealth Greeley HospitalRecruiting
- UCHealth Highlands Ranch HospitalRecruiting
- Medical Center of the RockiesRecruiting
- John Fitzgerald Kennedy Medical CenterRecruiting
- Morton Plant HospitalRecruiting
- GenesisCare USA - PlantationRecruiting
- Saint Luke's Cancer Institute - BoiseRecruiting
- Saint Luke's Cancer Institute - FruitlandRecruiting
- Saint Luke's Cancer Institute - MeridianRecruiting
- Saint Luke's Cancer Institute - NampaRecruiting
- Saint Luke's Cancer Institute - Twin FallsRecruiting
- Centralia Oncology ClinicRecruiting
- Saint Mary's HospitalRecruiting
- Northwestern UniversityRecruiting
- John H Stroger Jr Hospital of Cook CountyRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- Northwestern Medicine Lake Forest HospitalRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Loyola University Medical CenterRecruiting
- Cancer Care Center of O'FallonRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Northwest Cancer Center - Main CampusRecruiting
- Northwest Oncology LLCRecruiting
- Northwest Cancer Center - HobartRecruiting
- Saint Mary Medical CenterRecruiting
- The Community HospitalRecruiting
- Women's Diagnostic Center - MunsterRecruiting
- Memorial Hospital of South BendRecruiting
- Northwest Cancer Center - ValparaisoRecruiting
- Medical Oncology and Hematology Associates-West Des MoinesRecruiting
- Mercy Cancer Center-West LakesRecruiting
- Greater Regional Medical CenterRecruiting
- Iowa Methodist Medical CenterRecruiting
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Mercy Medical Center - Des MoinesRecruiting
- Mission Cancer and Blood - LaurelRecruiting
- Mercy Medical Center-West LakesRecruiting
- University of Kansas Cancer CenterRecruiting
- Olathe Health Cancer CenterRecruiting
- University of Kansas Cancer Center-Overland ParkRecruiting
- University of Kansas Hospital-Indian Creek CampusRecruiting
- Salina Regional Health CenterRecruiting
- University of Kansas Health System Saint Francis CampusRecruiting
- University of Kansas Hospital-Westwood Cancer CenterRecruiting
- Greater Baltimore Medical CenterRecruiting
- Henry Ford Cancer Institute-DownriverRecruiting
- GenesisCare USA - ClarkstonRecruiting
- Henry Ford Macomb Hospital-Clinton TownshipRecruiting
- Henry Ford Medical Center-FairlaneRecruiting
- Henry Ford HospitalRecruiting
- GenesisCare USA - Farmington HillsRecruiting
- Allegiance HealthRecruiting
- GenesisCare USA - MacombRecruiting
- GenesisCare USA - Madison HeightsRecruiting
- Henry Ford Medical Center-ColumbusRecruiting
- William Beaumont Hospital-Royal OakRecruiting
- William Beaumont Hospital - TroyRecruiting
- GenesisCare USA - TroyRecruiting
- Henry Ford West Bloomfield HospitalRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Saint Luke's Hospital of DuluthRecruiting
- Baptist Memorial Hospital and Cancer Center-Golden TriangleRecruiting
- Baptist Cancer Center-GrenadaRecruiting
- Baptist Memorial Hospital and Cancer Center-Union CountyRecruiting
- Baptist Memorial Hospital and Cancer Center-OxfordRecruiting
- Baptist Memorial Hospital and Cancer Center-DesotoRecruiting
- Saint Francis Medical CenterRecruiting
- Parkland Health Center - FarmingtonRecruiting
- University of Kansas Cancer Center - NorthRecruiting
- University of Kansas Cancer Center - Lee's SummitRecruiting
- University of Kansas Cancer Center at North Kansas City HospitalRecruiting
- Mercy Hospital SouthRecruiting
- Missouri Baptist Medical CenterRecruiting
- Mercy Hospital Saint LouisRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Cancer Partners of Nebraska - Pine LakeRecruiting
- Southeast Nebraska Cancer Center - 68th Street PlaceRecruiting
- Memorial Sloan Kettering Basking RidgeRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Montefiore Medical Center-Einstein CampusRecruiting
- Montefiore Medical Center-Weiler HospitalRecruiting
- Montefiore Medical Center - Moses CampusRecruiting
- Memorial Sloan Kettering CommackRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Highland HospitalRecruiting
- Pluta Cancer CenterRecruiting
- University of RochesterRecruiting
- Memorial Sloan Kettering NassauRecruiting
- Wilmot Cancer Institute at WebsterRecruiting
- Wake Forest University Health SciencesRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Miami Valley Hospital SouthRecruiting
- Miami Valley HospitalRecruiting
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Miami Valley Hospital NorthRecruiting
- Atrium Medical Center-Middletown Regional HospitalRecruiting
- Dayton Physicians LLC-AtriumRecruiting
- Dayton Physicians LLC - TroyRecruiting
- Upper Valley Medical CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Cancer Institute Clackamas ClinicRecruiting
- Legacy Mount Hood Medical CenterRecruiting
- Providence Newberg Medical CenterRecruiting
- Providence Willamette Falls Medical CenterRecruiting
- Legacy Good Samaritan Hospital and Medical CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Legacy Meridian Park HospitalRecruiting
- UPMC-Magee Womens HospitalRecruiting
- Women and Infants HospitalRecruiting
- Medical University of South CarolinaRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Baptist Memorial Hospital and Cancer Center-ColliervilleRecruiting
- Baptist Memorial Hospital and Cancer Center-MemphisRecruiting
- MD Anderson in The WoodlandsRecruiting
- M D Anderson Cancer CenterRecruiting
- MD Anderson West HoustonRecruiting
- MD Anderson League CityRecruiting
- MD Anderson in Sugar LandRecruiting
- Farmington Health CenterRecruiting
- University of Utah Sugarhouse Health CenterRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- Bon Secours Memorial Regional Medical CenterRecruiting
- Bon Secours Saint Francis Medical CenterRecruiting
- Bon Secours Saint Mary's HospitalRecruiting
- Bon Secours Cancer Institute at Reynolds CrossingRecruiting
- Legacy Cancer Institute Medical Oncology and Day TreatmentRecruiting
- Legacy Salmon Creek HospitalRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Froedtert Menomonee Falls HospitalRecruiting
- Medical College of WisconsinRecruiting
- ProHealth D N Greenwald CenterRecruiting
- Drexel Town Square Health CenterRecruiting
- ProHealth Oconomowoc Memorial HospitalRecruiting
- UW Cancer Center at ProHealth CareRecruiting
- Froedtert West Bend Hospital/Kraemer Cancer CenterRecruiting
- Cancer Center-Metro Medical Center BayamonRecruiting
- Doctors Cancer CenterRecruiting
- San Juan Community Oncology GroupRecruiting
- Centro Comprensivo de Cancer de UPRRecruiting
- San Juan City HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Standard of Care Adjuvant Breast Radiation
Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation
Patients continue to receive their current planned adjuvant breast radiation and systemic HER2-targeted therapies
Patients continue to receive their current systemic HER2-targeted therapy without breast adjuvant radiation