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Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients With High-Risk, Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer

Description

OBJECTIVES: Primary - To compare whether the addition of one year of everolimus (10 mg daily) to standard adjuvant endocrine therapy improves invasive disease-free survival (IDFS) in patients with high-risk, hormone-receptor (HR)-positive, and human epidermal growth factor receptor (HER)2-negative breast cancer. Secondary - To compare whether the addition of one year of everolimus to standard adjuvant endocrine therapy improves overall survival (OS) and distant recurrence-free survival (DRFS) in this patient population. - To evaluate the safety, toxicities, and tolerability of one year of everolimus in combination with standard adjuvant endocrine therapy and to compare it with standard adjuvant endocrine therapy plus placebo in this patient population. - To determine whether the benefit of one year of everolimus use in addition to standard adjuvant endocrine therapy varies by recurrence score (RS), nodal status, or other commonly used prognostic factors. - To evaluate adherence to 1-year treatment of everolimus in comparison to placebo in addition to standard adjuvant endocrine therapy in this patient population. - To collect specimens in order to evaluate biomarkers of therapeutic efficacy. (exploratory) OUTLINE: This is a multicenter study. Patients are stratified according to risk level (node-negative and recurrence score [RS] > 25 in the primary tumor, and a tumor measuring ≥ 2 cm in greatest diameter treated with adjuvant therapy vs 1-3 positive lymph nodes and RS > 25 treated with adjuvant therapy vs ≥ 4 positive lymph nodes [any RS value] treated with adjuvant therapy vs ≥ 4 positive lymph nodes [any RS value] prior to or after neoadjuvant chemotherapy). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive an approved endocrine therapy comprising tamoxifen citrate*, goserelin acetate** or leuprolide acetate**, or aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo orally (PO) daily for 1 year in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity. NOTE: *Men receive tamoxifen citrate PO for 5 years. NOTE: **Goserelin acetate or leuprolide acetate is given if patient is or becomes postmenopausal. Blood and tissue samples are collected for biomarker studies. After completion of study treatment, patients are followed up every 6 months for 2 years and then yearly thereafter for 10 years.

Phase

N/A

Inclusion and Exclusion Criteria

  • - Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen (ER)- and/or progesterone-receptor (PR) status, and negative human epidermal growth factor receptor (HER)2, for whom standard adjuvant endocrine therapy is planned - ER and PR positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as either ER or PR ≥ 1% positive nuclear staining - HER2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using IHC, ISH or both. HER2 is negative if a single test (or all tests) performed in a tumor specimen show:
  • IHC negative (0 or 1+)
  • ISH negative using single probe or dual probe. If IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+. HER2 equivocal is not eligible. - Patients must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral, and primary inflammatory breast cancers are allowed - Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant - Multicentric disease is defined as more than one invasive cancer ≥ 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants - Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other - Patients must be high risk by belonging to one of the following risk groups: - Completion of adjuvant chemotherapy and pathologically negative axillary nodes, and a tumor measuring ≥ 2 cm in greatest diameter, and an Oncotype DX

Sites

  • California

    • Los Angeles County-USC Medical Center, Los Angeles, California, 90033
    • Providence Saint Joseph Medical Center, Burbank, California, 91505
    • City of Hope, Duarte, California, 91010
    • Saint Joseph Hospital, Orange, California, 92868
    • UC San Diego Moores Cancer Center, LA Jolla, California, 92093
    • Mercy UC Davis Cancer Center, Merced, California, 95340
    • Community Hospital of Monterey Peninsula, Monterey, California, 93940
    • Valley Medical Oncology Consultants-Fremont, Fremont, California, 94538
    • Valley Medical Oncology Consultants-Castro Valley, Castro Valley, California, 94546
    • Mills - Peninsula Hospitals, Burlingame, California, 94010
    • East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill, Pleasant Hill, California, 94523
    • Tom K Lee Inc, Oakland, California, 94609
    • Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, 94704
    • California Pacific Medical Center, San Francisco, California, 94118
    • UC Davis Comprehensive Cancer Center, Sacramento, California, 95817
    • Sutter Solano Medical Center, Vallejo, California, 94589
    • Sutter Health Western Division Cancer Research Group, Greenbrae, California, 94904
    • Tahoe Forest Cancer Center, Truckee, California, 96161
    • Sutter Pacific Medical Foundation, Santa Rosa, California, 95403
  • Nevada

    • University Medical Center of Southern Nevada, Las Vegas, Nevada, 89102
    • Nevada Cancer Research Foundation CCOP, Las Vegas, Nevada, 89106
    • Carson-Tahoe Specialty Medical Center, Carson City, Nevada, 89703
  • Arizona

    • Arizona Cancer Center at UMC Orange Grove, Tucson, Arizona, 85704
    • Arizona Cancer Center at University Medical Center North, Tucson, Arizona, 85719
    • University of Arizona Health Sciences Center, Tucson, Arizona, 85724
  • New Mexico

    • University of New Mexico, Albuquerque, New Mexico, 87106
    • Hematology Oncology Associates, Albuquerque, New Mexico, 87106
    • Presbyterian Kaseman Hospital, Albuquerque, New Mexico, 87110
    • Memorial Medical Center - Las Cruces, Las Cruces, New Mexico, 88011
    • New Mexico Cancer Care Associates, Santa Fe, New Mexico, 87505
  • Oregon

    • Saint Charles Medical Center-Bend, Bend, Oregon, 97701
    • Bay Area Hospital, Coos Bay, Oregon, 97420
    • Providence Milwaukie Hospital, Milwaukie, Oregon, 97222
    • Legacy Mount Hood Medical Center, Glesham, Oregon, 97030
    • Columbia River Oncology Program, Portland, Oregon, 97225
  • Colorado

    • Memorial Hospital Colorado Springs, Colorado Springs, Colorado, 80909
    • Kaiser Permanente-Franklin, Denver, Colorado, 80205
    • Kaiser Permanente-Rock Creek, Lafayette, Colorado, 80026
    • Front Range Cancer Specialists, Fort Collins, Colorado, 80528
    • Poudre Valley Hospital, Fort Collins, Colorado, 80524
  • Washington

    • Northwest Cancer Specialists, Vancouver, Washington, 98684
    • Providence Centralia Hospital, Centralia, Washington, 98531
    • Saint Clare Hospital, Tacoma, Washington, 98499
    • Auburn Regional Medical Center, Auburn, Washington, 98002
    • Harborview Medical Center, Seattle, Washington, 98104
    • Group Health Cooperative, Seattle, Washington, 98112
    • Harrison Bremerton Hematology and Oncology, Bremerton, Washington, 98310
    • Harrison Poulsbo Hematology and Oncology, Poulsbo, Washington, 98370
    • United General Hospital, Sedro-Woolley, Washington, 98284
  • Montana

    • Montana Cancer Specialists, Missoula, Montana, 59802
    • Hematology-Oncology Centers of the Northern Rockies PC, Billings, Montana, 59102
    • Great Falls Clinic, Great Falls, Montana, 59405
  • Texas

    • Southwest Oncology Group (SWOG) Research Base, San Antonio, Texas, 78245
    • Baylor Medical Center at Irving, Irving, Texas, 75061
    • Baylor University Medical Center, Dallas, Texas, 75246
  • Oklahoma

    • Natalie W Bryant Cancer Center, Tulsa, Oklahoma, 74136
  • Nebraska

    • Lincoln Medical Education Foundation Cancer Resource Center, Lincoln, Nebraska, 68510
    • Alegent Health Lakeside Hospital, Omaha, Nebraska, 68130
    • Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, 68124
    • Alegent Health Immanuel Medical Center, Omaha, Nebraska, 68122
    • Missouri Valley Cancer Consortium CCOP, Omaha, Nebraska, 68106
    • Creighton University Medical Center, Omaha, Nebraska, 68131
  • South Dakota

    • Conklin Regional Cancer Center, Aberdeen, South Dakota, 57401
    • Avera Cancer Institute, Sioux Falls, South Dakota, 57105
  • Missouri

    • Saint John's Regional Medical Center, Joplin, Missouri, 64804
    • Freeman Health System, Joplin, Missouri, 64804
    • Central Care Cancer Center-Carrie J Babb Cancer Center, Bolivar, Missouri, 65613
    • Cox Medical Center, Springfield, Missouri, 65807
    • CoxHealth Cancer Center, Branson, Missouri, 65616
    • Saint John's Hospital, Springfield, Missouri, 65804
    • Saint John's Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, 65401
    • Phelps County Regional Medical Center, Rolla, Missouri, 65401
    • Saint John's Mercy Medical Center, Saint Louis, Missouri, 63141
    • Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, 63109
  • Louisiana

    • Louisiana State University, Shreveport, Louisiana, 71130
    • Christus Schumpert Saint Mary's Place, Shreveport, Louisiana, 71101
  • Iowa

    • Medical Oncology and Hematology Associates, Des Moines, Iowa, 50314
    • McFarland Clinic, Ames, Iowa, 50010
    • Ottumwa Regional Health Center, Ottumwa, Iowa, 52501
    • Constantinou, Costas L MD (UIA Investigator), Bettendorf, Iowa, 52722
  • Minnesota

    • CentraCare Clinic, Saint Cloud, Minnesota, 56303
    • Metro-Minnesota CCOP, Saint Louis Park, Minnesota, 55416
    • Mayo Clinic, Rochester, Minnesota, 55905
  • Arkansas

    • NEA Baptist Clinic-Matthews, Jonesboro, Arkansas, 72401
  • Illinois

    • Illinois CancerCare-Monmouth, Monmouth, Illinois, 61462
    • Spector, David MD (UIA Investigator), Moline, Illinois, 61265
    • Garneau, Stewart C MD (UIA Investigator), Moline, Illinois, 61265
    • Porubcin, Michael MD (UIA Investigator), Moline, Illinois, 61265
    • Trinity Medical Center, Moline, Illinois, 61265
    • Medical and Surgical Specialists, Galesburg, Illinois, 61401
    • Illinois Oncology Research Association CCOP, Peoria, Illinois, 61615
    • Proctor Hospital, Peoria, Illinois, 61614
    • Illinois CancerCare-Pekin, Pekin, Illinois, 61603
    • Good Samaritan Regional Medical Center, Mt. Vernon, Illinois, 62864
    • Swedish American Hospital, Rockford, Illinois, 61104
    • Ottawa Regional Hospital and Healthcare Center, Ottawa, Illinois, 61350
    • Carle Foundation - Carle Cancer Center, Urbana, Illinois, 61801
    • Sherman Hospital, Elgin, Illinois, 60123
    • Rush - Copley Medical Center, Aurora, Illinois, 60504
    • Presence Saint Mary's Hospital, Kankakee, Illinois, 60901
    • North Shore Hematology Oncology, Libertyville, Illinois, 60048
    • West Suburban Cancer Center, River Forest, Illinois, 60305
    • Illinois Cancer Specialists-Niles, Niles, Illinois, 60714
    • Hematology Oncology Associates of Illinois-Highland Park, Highland Park, Illinois, 60035
    • Hematology Oncology Associates of Illinois - Skokie, Skokie, Illinois, 60076
    • University of Illinois, Chicago, Illinois, 60612
    • Rush University Medical Center, Chicago, Illinois, 60612
    • Northwestern University, Chicago, Illinois, 60611
  • Wisconsin

    • Marshfield Clinic Cancer Center at Sacred Heart, Eau Claire, Wisconsin, 54701
    • Marshfield Clinic-Rice Lake Center, Rice Lake, Wisconsin, 54868
    • Marshfield Clinic-Chippewa Center, Chippewa Falls, Wisconsin, 54729
    • Marshfield Clinic, Marshfield, Wisconsin, 54449
    • Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, 54494
    • Marshfield Clinic Cancer Care at Saint Michael's Hospital, Stevens Point, Wisconsin, 54481
    • Marshfield Clinic-Wausau Center, Wausau, Wisconsin, 54401
    • Marshfield Clinic - Weston Center, Weston, Wisconsin, 54476
    • Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, 54548
    • Aurora Medical Center in Summit, Summit, Wisconsin, 53066
    • Marshfield Clinic at James Beck Cancer Center, Rhinelander, Wisconsin, 54501
    • Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh, Wisconsin, 54904
    • Columbia Saint Mary's Hospital - Ozaukee, Mequon, Wisconsin, 53097
    • Columbia Saint Mary's Water Tower Medical Commons, Milwaukee, Wisconsin, 53211
    • Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan, Wisconsin, 53081
    • Vince Lombardi Cancer Clinic, Two Rivers, Wisconsin, 54241
    • Vince Lombardi Cancer Clinic-Marinette, Marinette, Wisconsin, 54143
  • Tennessee

    • Nashville Breast Center, Nashville, Tennessee, 37203
    • Vanderbilt Breast Center at One Hundred Oaks, Nashville, Tennessee, 37204
    • Vanderbilt-Ingram Cancer Center Cool Springs, Franklin, Tennessee, 37067
  • Indiana

    • Saint Anthony Memorial Health Center, Michigan City, Indiana, 46360
    • Indiana University Medical Center, Indianapolis, Indiana, 46202
    • Wishard Hospital, Indianapolis, Indiana, 46202
    • Franciscan St. Francis Health, Indianapolis, Indiana, 46237
  • Michigan

    • Marquette General Hospital, Marquette, Michigan, 49855
    • Central Michigan Community Hospital, Mount Pleasant, Michigan, 48858
  • Kentucky

    • University of Kentucky, Lexington, Kentucky, 40536
  • Ohio

    • Grandview Hospital, Dayton, Ohio, 45405
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