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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00390455
Other study ID # NCI-2009-00475
Secondary ID NCI-2009-00475CD
Status Completed
Phase Phase 3
First received
Last updated
Start date September 15, 2006
Est. completion date July 2, 2014

Study information

Verified date November 2019
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase III trial studies fulvestrant and lapatinib to see how well they work compared to fulvestrant and a placebo in treating postmenopausal women with stage III or stage IV breast cancer that is hormone receptor-positive. Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of breast cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether fulvestrant is more effective with or without lapatinib in treating breast cancer.


Description:

PRIMARY OBJECTIVES:

I. To compare the effect, in terms of progression free survival, of the antiestrogen fulvestrant alone with fulvestrant administered in combination with the dual-kinase inhibitor lapatinib for postmenopausal women with estrogen receptor (ER) and/or progesterone receptor (PgR) positive advanced breast cancer.

SECONDARY OBJECTIVES:

I. To compare the effects of fulvestrant alone with fulvestrant and lapatinib on other clinical endpoints, including response rate, response and stable disease rate (complete response [CR] + partial response [PR] + stable disease >= 6 months), duration of response, overall survival, symptom checklist scores, and toxicity.

II. To define predictive markers of clinical activity among women receiving fulvestrant with or without lapatinib.

III. To determine if the clinical benefits for combination of hormonal and growth factor inhibitor therapy are most pronounced in women whose tumors express higher levels of ER, epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (HER2), phosphorylated protein kinase B (pAkt), and/or phosphorylated mitogen-activated protein kinase 1/2 (pERK1/2).

IV. To serologically determine if HER2 extracellular domain (ECD) and EGFR ECD levels can identify patients with a greater likelihood of response and clinical benefit to fulvestrant with or without lapatinib.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive lapatinib ditosylate orally (PO) once daily (QD) on days 1-28 and fulvestrant intramuscularly (IM) on days 1 and 15 of course 1 and on day 1 of each subsequent course.

ARM II: Patients receive placebo PO QD on days 1-28 and fulvestrant as in Arm I.

In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 3 years.


Recruitment information / eligibility

Status Completed
Enrollment 295
Est. completion date July 2, 2014
Est. primary completion date July 1, 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologic, pathologic or cytologic diagnosis of cancer of the female breast in either primary or metastatic setting; histological documentation of metastatic/recurrent disease is not required if there is unequivocal clinical evidence for recurrence

- Stage IV breast cancer (using American Joint Committee on Cancer [AJCC] criteria, 6th edition), or locally advanced (stage III) breast cancer not considered amenable to curative therapy

- Patients with symptomatic brain metastases or other symptomatic central nervous system (CNS) metastases are not eligible for the study; no screening studies are required among asymptomatic patients; patients with previously treated brain metastases, who are free of symptoms referable to CNS disease and who are > 3 months from treatment for brain metastases are eligible

- Tumors (as determined on pathology from either primary or metastatic sites) must be potentially sensitive to endocrine therapy, defined as expressing estrogen receptor (ER) and/or progesterone receptor (PgR) as determined immunohistochemical methods according to the local institution's standard protocol, >= 1% cells will be considered to be positive

- The protocol has been amended to permit tumors with any HER2 status, though a determination of HER2 status must have been made; patients will be considered to be eligible if HER2 expression is documented by one of the following methods:

- Immunohistochemistry (IHC) 0 (i.e., negative), 1+, 2+, or 3+ levels of expression, or

- Gene amplification (fluorescent in situ hybridization [FISH]) positive or negative

- Patients must have at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2.0 cm with conventional techniques or as >= 1.0 cm with spiral computed tomography (CT) scan

- Exception: Patients with lytic or blastic bone metastases as their only site of disease will be eligible for the study even though these patients are not considered to have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria; these patients will be evaluable for time to progression, but not response

- Patients with all other lesions, including small lesions (longest diameter < 2.0 cm with conventional techniques or < 1.0 cm with spiral CT scan) and truly non-measurable lesions including those listed below are not eligible

- Lesions that are considered non-measurable include the following:

- Bone lesions (women with bone lesions will be eligible as described above)

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast cancer

- Lymphangitis cutis/pulmonitis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Patients must have had one or two prior endocrine treatments for breast cancer in either the adjuvant or metastatic setting, exclusive of treatment-related amenorrhea or ovarian suppression; sequential use of two different third-generation aromatase inhibitors is considered "one" treatment; it is not required that tumors be resistant to such treatments; for example:

- A patient with de novo metastatic breast cancer who had never received endocrine therapy is not eligible;

- A patient who received adjuvant tamoxifen and subsequent therapy with an aromatase inhibitor (adjuvant or metastatic) is eligible;

- A patient who received an aromatase inhibitor in either the adjuvant or metastatic setting, and who discontinued therapy after several months because of side effects, is eligible;

- A patient who received an aromatase inhibitor in the adjuvant setting is eligible, regardless of whether they did or did not receive tamoxifen at some point;

- A patient who received adjuvant tamoxifen, and subsequently a nonsteroidal aromatase inhibitor and a steroidal aromatase inhibitor for advanced breast cancer in the adjuvant or metastatic setting is eligible;

- A patient who received adjuvant tamoxifen, and then a nonsteroidal aromatase inhibitor and subsequently megesterol acetate for advanced breast cancer is not eligible

- Tumors potentially sensitive to endocrine therapy, defined as >= 3 months of prior endocrine therapy without disease progression in the adjuvant or metastatic setting

- Patients must have had prior treatment in either the adjuvant or metastatic setting with a commercially available third-generation aromatase inhibitor (i.e. anastrozole, exemestane, or letrozole); it is not required that tumors be resistant to such therapies

- Patients may have received up to one prior chemotherapy regimen for stage IV breast cancer; prior chemotherapy in the adjuvant and/or neoadjuvant setting is permitted; patients must have finished chemotherapy at least 1 week prior to starting protocol based treatment

- Patients may have received prior trastuzumab therapy for stage IV breast cancer, in combination with up to one chemotherapy and/or endocrine therapy regimen, but that must have concluded at least 3 weeks prior to starting protocol-based therapy; prior trastuzumab therapy in the adjuvant and/or neoadjuvant setting is permitted, but must have concluded at least 3 weeks prior to starting protocol-based therapy

- Prior therapy with commercially available inhibitor of EGFR (including but not limited to gefitinib, erlotinib, lapatinib or cetuximab) or experimental inhibitors of EGFR is prohibited

- Patients may have initiated bisphosphonate therapy prior to study entry; such patients will have bone lesions considered evaluable for progression but not for response

- Prior fulvestrant therapy is prohibited

- Patients receiving a gonadotropin-releasing hormone (GnRH) agonist for ovarian suppression must remain on such therapy throughout the course of protocol treatment; patients must discontinue other endocrine treatments, including systemic hormone-replacement therapy and intravaginal estrogens prior to study entry; patients must have concluded radiation therapy prior to study entry; patients must be at least 1 week from prior chemotherapy or 3 weeks from prior trastuzumab therapy, with adequate recovery of bone marrow function and performance status

- Patients must be postmenopausal women, defined as a woman fulfilling any of the following criteria:

- Age >= 60 years; or

- Age >= 45 years with an intact uterus and amenorrhea for 12 months or more; or

- History of bilateral oophorectomy; or

- Follicle stimulating hormone (FSH) levels within postmenopausal range according to the ranges established by the testing facility; or

- Treatment with a GnRH agonist for ovarian suppression for at least 3 consecutive months prior to study registration, and remaining on such therapy throughout the course of protocol treatment

- Women who are pregnant or nursing are not eligible for the study; clinicians should advise patients that there are no data for the safety of lapatinib or fulvestrant among pregnant patients, nor data on the impact of these agents on fertility or pregnancy

- Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-2

- Absence of pending visceral crisis, in the opinion of the treating physician

- Absence of acquired or inherited bleeding disorder

- Absence of need for therapeutic systemic anticoagulation (defined as maintaining international normalized ratio [INR] > 1.6); patients may take low-dose warfarin or aspirin (or equivalent) for maintenance of central venous catheter patency

- Granulocytes >= 1,000/µl

- Platelet count >= 100,000/µl

- Creatinine =< 2 mg/dl

- Total bilirubin =< 1.5 x upper limits of normal (ULN) unless due to Gilbert's syndrome

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN without liver metastases; =< 5 x ULN with liver metastases

- INR =< 1.6

- Left ventricular ejection fraction (LVEF) within institutional limits of normal

Study Design


Intervention

Drug:
Fulvestrant
Given IM
Other:
Laboratory Biomarker Analysis
Correlative studies
Drug:
Lapatinib Ditosylate
Given PO
Other:
Placebo Administration
Given PO

Locations

Country Name City State
United States Avera Cancer Institute-Aberdeen Aberdeen South Dakota
United States Abington Memorial Hospital Abington Pennsylvania
United States Cleveland Clinic Akron General Akron Ohio
United States Saint Anthony's Health Alton Illinois
United States American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah
United States McFarland Clinic PC - Ames Ames Iowa
United States AnMed Health Hospital Anderson South Carolina
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Hospital District Sixth of Harper County Anthony Kansas
United States Arroyo Grande Community Arroyo Grande California
United States PCR Oncology Arroyo Grande California
United States Mission Hospital Asheville North Carolina
United States Rush - Copley Medical Center Aurora Illinois
United States Greater Baltimore Medical Center Baltimore Maryland
United States Saint Agnes Hospital Baltimore Maryland
United States University of Maryland/Greenebaum Cancer Center Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States Baton Rouge General Medical Center Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States Franciscan Saint Francis Health-Beech Grove Beech Grove Indiana
United States Mary Rutan Hospital Bellefontaine Ohio
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont
United States Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania
United States University of Iowa Healthcare Cancer Services Quad Cities Bettendorf Iowa
United States Spectrum Health Big Rapids Hospital Big Rapids Michigan
United States Billings Clinic Cancer Center Billings Montana
United States Montana Cancer Consortium NCORP Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States Saint Vincent Frontier Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Mid Dakota Clinic Bismarck North Dakota
United States Saint Alexius Medical Center Bismarck North Dakota
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Saint Joseph Medical Center Bloomington Illinois
United States Boca Raton Regional Hospital Boca Raton Florida
United States Saint Luke's Mountain States Tumor Institute Boise Idaho
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Bozeman Deaconess Hospital Bozeman Montana
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Saint Vincent's Medical Center Bridgeport Connecticut
United States Roswell Park Cancer Institute Buffalo New York
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States University of Vermont and State Agricultural College Burlington Vermont
United States Fairview Ridges Hospital Burnsville Minnesota
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Cooper Hospital University Medical Center Camden New Jersey
United States Aultman Health Foundation Canton Ohio
United States Graham Hospital Association Canton Illinois
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Missouri Hospital Cape Girardeau Missouri
United States Memorial Hospital Carthage Illinois
United States East Bay Radiation Oncology Center Castro Valley California
United States Eden Hospital Medical Center Castro Valley California
United States Valley Medical Oncology Consultants-Castro Valley Castro Valley California
United States Sandra L Maxwell Cancer Center Cedar City Utah
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Saint Luke's Hospital Chesterfield Missouri
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States University of Illinois Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States UCHealth Memorial Hospital Central Colorado Springs Colorado
United States Missouri Cancer Associates Columbia Missouri
United States University of Missouri - Ellis Fischel Columbia Missouri
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States New Hampshire Oncology Hematology PA-Concord Concord New Hampshire
United States Mercy Hospital Coon Rapids Minnesota
United States Heartland Oncology and Hematology LLP Council Bluffs Iowa
United States Danville Regional Medical Center Danville Virginia
United States Genesis Cancer Care Institute Davenport Iowa
United States Genesis Medical Center - East Campus Davenport Iowa
United States Dayton Veterans Affairs Medical Center Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Decatur Memorial Hospital Decatur Illinois
United States Heartland Cancer Research NCORP Decatur Illinois
United States Grady Memorial Hospital Delaware Ohio
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Capitol Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Saint Luke's Hospital of Duluth Duluth Minnesota
United States Duke University Medical Center Durham North Carolina
United States Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York
United States University of Maryland Shore Medical Center at Easton Easton Maryland
United States Fairview-Southdale Hospital Edina Minnesota
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Elkhart Clinic Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Union Hospital of Cecil County Elkton Maryland
United States Bay Area Breast Surgeons Inc Emeryville California
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Eureka Hospital Eureka Illinois
United States Saint Anne's Hospital Fall River Massachusetts
United States Blanchard Valley Hospital Findlay Ohio
United States Poudre Valley Hospital Fort Collins Colorado
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Fort Wayne Medical Oncology and Hematology Inc-Parkview Fort Wayne Indiana
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Frederick Memorial Hospital Frederick Maryland
United States Valley Medical Oncology Consultants-Fremont Fremont California
United States Unity Hospital Fridley Minnesota
United States Galesburg Cottage Hospital Galesburg Illinois
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States CaroMont Regional Medical Center Gastonia North Carolina
United States Glendale Memorial Hospital and Health Center Glendale California
United States Addison Gilbert Hospital Gloucester Massachusetts
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Goshen Center for Cancer Care Goshen Indiana
United States Altru Cancer Center Grand Forks North Dakota
United States Cancer Research Consortium of West Michigan NCORP Grand Rapids Michigan
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Berdeaux, Donald MD (UIA Investigator) Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin
United States Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Mason District Hospital Havana Illinois
United States Saint Rose Hospital Hayward California
United States Saint Peter's Community Hospital Helena Montana
United States Maria Parham Hospital Henderson North Carolina
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Holland Community Hospital Holland Michigan
United States New Hampshire Oncology Hematology PA-Hooksett Hooksett New Hampshire
United States Hopedale Medical Complex - Hospital Hopedale Illinois
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Cancer Center of Kansas-Independence Independence Kansas
United States Cleveland Clinic Cancer Center Independence Independence Ohio
United States Community Cancer Center East Indianapolis Indiana
United States Community Cancer Center North Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States Mercyhealth Hospital and Cancer Center - Janesville Janesville Wisconsin
United States Joliet Oncology-Hematology Associates Limited Joliet Illinois
United States Freeman Health System Joplin Missouri
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Glacier Oncology PLLC Kalispell Montana
United States Kalispell Medical Oncology Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States Presence Saint Mary's Hospital Kankakee Illinois
United States University of Kansas Cancer Center Kansas City Kansas
United States Keesler Medical Center Keesler Air Force Base Mississippi
United States Kadlec Clinic Hematology and Oncology Kennewick Washington
United States Kettering Medical Center Kettering Ohio
United States Kewanee Hospital Kewanee Illinois
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Wellmont Holston Valley Hospital and Medical Center Kingsport Tennessee
United States Vidant Oncology-Kinston Kinston North Carolina
United States University of Tennessee - Knoxville Knoxville Tennessee
United States Community Howard Regional Health Kokomo Indiana
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States AMITA Health Adventist Medical Center La Grange Illinois
United States IU Health La Porte Hospital La Porte Indiana
United States LRGHealthcare-Lakes Region General Hospital Laconia New Hampshire
United States Fairfield Medical Center Lancaster Ohio
United States Saint Mary Medical and Regional Cancer Center Langhorne Pennsylvania
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Beebe Medical Center Lewes Delaware
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Southwest Medical Center Liberal Kansas
United States Saint Rita's Medical Center Lima Ohio
United States Meeker County Memorial Hospital Litchfield Minnesota
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Saint Barnabas Medical Center Livingston New Jersey
United States Logan Regional Hospital Logan Utah
United States Doctors Carrol, Sheth, Raghavan Louisville Kentucky
United States Lowell General Hospital Lowell Massachusetts
United States Southeastern Regional Medical Center Lumberton North Carolina
United States Mcdonough District Hospital Macomb Illinois
United States Dean Hematology and Oncology Clinic Madison Wisconsin
United States Elliot Hospital Manchester New Hampshire
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Marietta Memorial Hospital Marietta Ohio
United States Bay Area Medical Center Marinette Wisconsin
United States Fremont - Rideout Cancer Center Marysville California
United States Mercy Medical Center - North Iowa Mason City Iowa
United States Loyola University Medical Center Maywood Illinois
United States University of Tennessee Health Science Center Memphis Tennessee
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Mid-Michigan Medical Center - Midland Midland Michigan
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Virginia Piper Cancer Institute Minneapolis Minnesota
United States Trinity Cancer Care Center Minot North Dakota
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Community Medical Hospital Missoula Montana
United States Guardian Oncology and Center for Wellness Missoula Montana
United States Montana Cancer Specialists Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Morristown Medical Center Morristown New Jersey
United States Virtua Memorial Mount Holly New Jersey
United States Northern Westchester Hospital Mount Kisco New York
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Skagit Valley Hospital Mount Vernon Washington
United States El Camino Hospital Mountain View California
United States Palo Alto Medical Foundation-Camino Division Mountain View California
United States Cottonwood Hospital Medical Center Murray Utah
United States Intermountain Medical Center Murray Utah
United States Mercy Health Mercy Campus Muskegon Michigan
United States Mercy Health Partners-Hackley Campus Muskegon Michigan
United States Yale University New Haven Connecticut
United States Louisiana State University Health Science Center New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States Memorial Sloan Kettering Cancer Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Licking Memorial Hospital Newark Ohio
United States Cancer Center of Kansas - Newton Newton Kansas
United States Bromenn Regional Medical Center Normal Illinois
United States Community Cancer Center Foundation Normal Illinois
United States Southwest VA Regional Cancer Center Norton Virginia
United States Alta Bates Summit Medical Center - Summit Campus Oakland California
United States Bay Area Tumor Institute Oakland California
United States Hematology and Oncology Associates-Oakland Oakland California
United States Highland General Hospital Oakland California
United States Tom K Lee Inc Oakland California
United States Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin
United States McKay-Dee Hospital Center Ogden Utah
United States Nebraska Methodist Hospital Omaha Nebraska
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Ottumwa Regional Health Center Ottumwa Iowa
United States Granville Medical Center Oxford North Carolina
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois
United States Pekin Hospital Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois Valley Hospital Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst North Carolina
United States Via Christi Hospital-Pittsburg Pittsburg Kansas
United States Valley Care Health System - Pleasanton Pleasanton California
United States Valley Medical Oncology Consultants Pleasanton California
United States Portneuf Medical Center Pocatello Idaho
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Perry Memorial Hospital Princeton Illinois
United States Utah Valley Regional Medical Center Provo Utah
United States Duke Raleigh Hospital Raleigh North Carolina
United States Rapid City Regional Hospital Rapid City South Dakota
United States Reid Health Richmond Indiana
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States West Suburban Medical Center River Forest Illinois
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States OSF Saint Anthony Medical Center Rockford Illinois
United States Person Memorial Hospital Roxboro North Carolina
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Rutherford Hospital Rutherfordton North Carolina
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Dixie Medical Center Regional Cancer Center Saint George Utah
United States Lakeland Medical Center Saint Joseph Saint Joseph Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Oncology Care Associates PLLC Saint Joseph Michigan
United States Center for Cancer Care and Research Saint Louis Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis-Cape Girardeau CCOP Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Metro Minnesota Community Oncology Research Consortium Saint Louis Park Minnesota
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States Saint Joseph's Hospital - Healtheast Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Cancer Center of Kansas - Salina Salina Kansas
United States Salinas Valley Memorial Salinas California
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States Intermountain Health Care Salt Lake City Utah
United States LDS Hospital Salt Lake City Utah
United States Utah Cancer Specialists-Salt Lake City Salt Lake City Utah
United States Kaiser Permanente-San Diego Mission San Diego California
United States UCSF Medical Center-Mount Zion San Francisco California
United States Zuckerberg San Francisco General Hospital San Francisco California
United States Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo California
United States Kaiser Permanente Washington Seattle Washington
United States Minor and James Medical PLLC Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States University of Washington Medical Center Seattle Washington
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Welch Cancer Center Sheridan Wyoming
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Avera McKennan Hospital and University Health Center Sioux Falls South Dakota
United States Medical X-Ray Center Sioux Falls South Dakota
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Memorial Hospital of South Bend South Bend Indiana
United States Michiana Hematology Oncology PC-South Bend South Bend Indiana
United States Northern Indiana Cancer Research Consortium South Bend Indiana
United States Spartanburg Medical Center Spartanburg South Carolina
United States Cancer Care Northwest - Spokane South Spokane Washington
United States Evergreen Hematology and Oncology PS Spokane Washington
United States Saint Margaret's Hospital Spring Valley Illinois
United States Memorial Medical Center Springfield Illinois
United States Springfield Regional Medical Center Springfield Ohio
United States Staten Island University Hospital Staten Island New York
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Overlook Hospital Summit New Jersey
United States State University of New York Upstate Medical University Syracuse New York
United States Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas
United States Smilow Cancer Hospital-Torrington Care Center Torrington Connecticut
United States Munson Medical Center Traverse City Michigan
United States Saint Francis Medical Center Trenton New Jersey
United States Upper Valley Medical Center Troy Ohio
United States Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California
United States Carle Cancer Center Urbana Illinois
United States Northbay Cancer Center Vacaville California
United States Inspira Medical Center Vineland Vineland New Jersey
United States Virtua Voorhees Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States MedStar Georgetown University Hospital Washington District of Columbia
United States Sibley Memorial Hospital Washington District of Columbia
United States Harold Leever Regional Cancer Center Waterbury Connecticut
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Wenatchee Valley Hospital and Clinics Wenatchee Washington
United States Saint Ann's Hospital Westerville Ohio
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Rice Memorial Hospital Willmar Minnesota
United States Clinton Memorial Hospital Wilmington Ohio
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Woodwinds Health Campus Woodbury Minnesota
United States Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio
United States UMass Memorial Medical Center - University Campus Worcester Massachusetts
United States Wright-Patterson Medical Center Wright-Patterson Air Force Base Ohio
United States Metro Health Hospital Wyoming Michigan
United States Greene Memorial Hospital Xenia Ohio
United States York Hospital York Maine
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Progression-free Survival for Participants With HER2-negative Tumors PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first. Up to 5 years
Other Progression-free Survival for Participants With HER2-positive Tumors PFS was defined as the interval from study entry until disease progression or death resulting from any cause, whichever occurred first. Up to 5 years
Other Objective Tumor Response Rate for Participants With HER2-negative Tumors Response was defined by the RECIST. A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions). The response rate of measurable tumors will be estimated with its 95% confidence interval according to treatment arm. Up to 5 years
Other Objective Tumor Response Rate for Participants With HER2-positive Tumors Response was defined by the RECIST. A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions). The response rate of measurable tumors will be estimated with its 95% confidence interval according to treatment arm. Up to 5 years
Primary Progression-free Survival (PFS) PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per RECIST criteria). Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years
Secondary Objective Tumor Response Rate Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions). The response rate of measurable tumors will be estimated with its 95% confidence interval according to treatment arm. Up to 5 years
Secondary Overall Survival (OS) Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Study entry to death or last follow-up, up to 5 years
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