Male Breast CarcinomaPhase 2NCT00861705
Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery
A Phase 2 study testing Bevacizumab, Carboplatin and Cyclophosphamide in people with Male Breast Carcinoma and Stage IIA Breast Cancer AJCC v6 and v7, run by National Cancer Institute (NCI) at 448 sites in United States.
Trial summary
This randomized phase II trial studies how well paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Male Breast Carcinoma, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7
- What is being tested?
- Bevacizumab, Carboplatin and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 454 participants
- Where
- 448 sitesUnited States
- Study dates
- 21 Jul 2009to 2 Sep 2025
- 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
- Invasive breast cancer, diagnosed by core needle or incisional biopsy (excisional biopsy not permitted)
- The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor (ER) and progesterone receptor (PgR) negative or staining present in =< 10% of invasive cancer cells by immunohistochemistry (IHC)
- The invasive tumor must be HER2-negative, defined as IHC 0-1+ or with a fluorescent in situ hybridization (FISH) ratio (HER2 gene copy/chromosome 17) of < 2.0 if IHC 2+
- Clinical stage II-III invasive breast cancer with intent to perform surgical resection after neoadjuvant therapy; patients with inflammatory breast cancer are not eligible; staging to rule out metastatic disease is recommended for clinical stage III patients
- Patients with multicentric or bilateral disease are eligible if the target lesion meets eligibility criteria
- Patient agrees to undergo pretreatment research biopsies
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- No prior chemotherapy, hormone therapy, or radiation therapy with therapeutic intent for this cancer
- The target lesion in the breast must be >= 1 cm, clinically or radiographically; palpable or radiographically measurable axillary adenopathy will be recorded but will not serve as measurable disease for the primary endpoint; patients with axillary disease only (no identifiable tumor in the breast that is >= 1 cm on physical exam or radiographic study) are not eligible to participate
- Patients with a history of significant bleeding episodes (e.g., hemoptysis, upper or lower gastrointestinal [GI] bleeding) within 6 months of registration are not eligible
- No serious or non-healing wound, skin ulcers or bone fracture; no abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within the past 6 months; no major surgical procedure within 28 days prior to randomization or anticipation of need for major surgery during the course of study
- The following are not considered to be major surgical procedures that would be prohibited in the 28 days prior to, or following study randomization: obtaining the required research needle biopsies; placement of a radiopaque clip to localize a tumor or tumors for subsequent surgical resection; placement of a port for central venous access; fine needle aspiration of a prominent or suspicious axillary lymph node; needle biopsy of a clinically or radiographically detected lesion to rule out metastatic disease; or pretreatment sentinel lymph node sampling
- No baseline neuropathy grade >= 2
- Zubrod performance status 0-1
- Pregnant or nursing women are not eligible; all women of reproductive potential must have a negative pregnancy test at baseline and agree to use an effective, non-hormonal method of contraception during the entire period of treatment on the study
- Patients with congestive heart failure are not eligible, nor are patients with myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia attack (TIA) within the past 12 months, uncontrolled hypertension (systolic blood pressure [SBP] > 160 or diastolic blood pressure [DBP] > 90), uncontrolled or symptomatic arrhythmia, or grade II or greater peripheral vascular disease
- Patients must have a pretreatment multi gated acquisition (MUGA) scan or echocardiogram with a left ventricular ejection fraction (LVEF) above the institutional lower limit of normal
- Granulocytes > 1,000/mcl
- Platelets > 100,000/mcl
- Total bilirubin =< 1.5 x upper limits of normal
- Calculated or measured > 30 ml/min
- Urine protein =< 1+ or urine protein to creatinine (UPC) ratio < 1
- Patients discovered to have >= 2+ proteinuria at baseline must undergo a 24-hour urine collection that must demonstrate < 1 g of protein/24 hr, or UPC ratio < 1 to allow participation in the study
- Serum alanine aminotransferase (ALT) =< 2.5 x upper limits of normal
- Serum beta human chorionic gonadotropin (HCG) negative (for women of child bearing potential)
- Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN)
- Unless patient is on therapeutic doses of warfarin; if so, the patient must have an INR =< 3 on a stable dose of warfarin, must have not active bleeding or pathologic condition that is associated with a high risk of bleeding
Who cannot join
None listed.
Trial locations and contacts
448 sites in 1 country.
300 sites in 1 country
United States300 sites
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Bixby Medical Center
Adrian, Michigan, 49221
Hickman Cancer Center
Adrian, Michigan, 49221
Summa Health System - Akron Campus
Akron, Ohio, 44304
Cleveland Clinic Akron General
Akron, Ohio, 44307
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221
AnMed Health Cancer Center
Anderson, South Carolina, 29621
AnMed Health Hospital
Anderson, South Carolina, 29621
Fox Valley Surgical Associates Limited
Appleton, Wisconsin, 54911
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Randolph Hospital
Asheboro, North Carolina, 27203
Mission Hospital
Asheville, North Carolina, 28801
Piedmont Hospital
Atlanta, Georgia, 30309
Atlanta Regional CCOP
Atlanta, Georgia, 30342
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Northside Hospital
Atlanta, Georgia, 30342
MultiCare Auburn Medical Center
Auburn, Washington, 98001
The Medical Center of Aurora
Aurora, Colorado, 80012
WellStar Cobb Hospital
Austell, Georgia, 30106
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237
Eastern Maine Medical Center
Bangor, Maine, 04401
Summa Health System - Barberton Campus
Barberton, Ohio, 44203
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, 46107
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015
Billings Clinic Cancer Center
Billings, Montana, 59101
Saint Vincent Healthcare
Billings, Montana, 59101
Montana Cancer Consortium NCORP
Billings, Montana, 59102
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, 43402
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Cox Cancer Center Branson
Branson, Missouri, 65616
Hartford HealthCare - Saint Vincent's Medical Center
Bridgeport, Connecticut, 06606
Maimonides Medical Center
Brooklyn, New York, 11219
Coney Island Hospital
Brooklyn, New York, 11235
Roswell Park Cancer Institute
Buffalo, New York, 14263
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Highline Medical Center-Main Campus
Burien, Washington, 98166
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
Butler Memorial Hospital
Butler, Pennsylvania, 16001
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Aultman Health Foundation
Canton, Ohio, 44710
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
Rocky Mountain Oncology
Casper, Wyoming, 82609
East Bay Radiation Oncology Center
Castro Valley, California, 94546
Eden Hospital Medical Center
Castro Valley, California, 94546
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, 94546
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
Saint Luke's Hospital
Cedar Rapids, Iowa, 52402
Mercy Hospital
Cedar Rapids, Iowa, 52403
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Roper Hospital
Charleston, South Carolina, 29401
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Erlanger Medical Center
Chattanooga, Tennessee, 37403
Saint Luke's Hospital
Chesterfield, Missouri, 63017
Mount Sinai Hospital Medical Center
Chicago, Illinois, 60608
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
University of Illinois
Chicago, Illinois, 60612
Presence Resurrection Medical Center
Chicago, Illinois, 60631
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Weiss Memorial Hospital
Chicago, Illinois, 60640
North Coast Cancer Care-Clyde
Clyde, Ohio, 43410
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212
John B Amos Cancer Center
Columbus, Georgia, 31904
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301
Mercy Hospital
Coon Rapids, Minnesota, 55433
Bay Area Hospital
Coos Bay, Oregon, 97420
Grandview Hospital
Dayton, Ohio, 45405
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406
Miami Valley Hospital
Dayton, Ohio, 45409
Miami Valley Hospital North
Dayton, Ohio, 45415
Dayton NCI Community Oncology Research Program
Dayton, Ohio, 45459
Emory Decatur Hospital
Decatur, Georgia, 30033
AdventHealth Porter
Denver, Colorado, 80210
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218
Rose Medical Center
Denver, Colorado, 80220
Western States Cancer Research NCORP
Denver, Colorado, 80222
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
Miller-Dwan Hospital
Duluth, Minnesota, 55805
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057
Fairview Southdale Hospital
Edina, Minnesota, 55435
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042
Elkhart Clinic
Elkhart, Indiana, 46514-2098
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514
Elkhart General Hospital
Elkhart, Indiana, 46515
Christiana Care - Union Hospital
Elkton, Maryland, 21921
Elmhurst Hospital Center
Elmhurst, New York, 11373
Hematology Oncology Center Incorporated
Elyria, Ohio, 44035
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035
Bay Area Breast Surgeons Inc
Emeryville, California, 94608
Epic Care Partners in Cancer Care
Emeryville, California, 94608
Swedish Medical Center
Englewood, Colorado, 80113
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
Exeter Hospital
Exeter, New Hampshire, 03833
Piedmont Fayette Hospital
Fayetteville, Georgia, 30214
Saint Francis Hospital
Federal Way, Washington, 98003
Blanchard Valley Hospital
Findlay, Ohio, 45840
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Aurora Cancer Care-Franklin
Franklin, Wisconsin, 53132
Frederick Memorial Hospital
Frederick, Maryland, 21701
Fredericksburg Oncology Inc
Fredericksburg, Virginia, 22401
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia, 22408
Valley Medical Oncology Consultants-Fremont
Fremont, California, 94538
Unity Hospital
Fridley, Minnesota, 55432
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Adams Cancer Center
Gettysburg, Pennsylvania, 17325
Aurora Cancer Care-Glendale
Glendale, Wisconsin, 53212
Glens Falls Hospital
Glens Falls, New York, 12801
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534
Altru Cancer Center
Grand Forks, North Dakota, 58201
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Great Falls Clinic
Great Falls, Montana, 59405
Banner North Colorado Medical Center
Greeley, Colorado, 80631
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Cone Health Cancer Center
Greensboro, North Carolina, 27403
Wayne Hospital
Greenville, Ohio, 45331
Saint Francis Hospital
Greenville, South Carolina, 29601
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
Greenwich Hospital
Greenwich, Connecticut, 06830
Self Regional Healthcare
Greenwood, South Carolina, 29646
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Virginia Oncology Associates-Hampton
Hampton, Virginia, 23666
WellSpan Medical Oncology and Hematology
Hanover, Pennsylvania, 17331
Hartford Hospital
Hartford, Connecticut, 06102
Northern Montana Hospital
Havre, Montana, 59501
HaysMed
Hays, Kansas, 67601
Saint Peter's Community Hospital
Helena, Montana, 59601
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Hawaii Cancer Care Inc - Waterfront Plaza
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
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Saint Mary's Medical Center
Huntington, West Virginia, 25702
Hutchinson Regional Medical Center
Hutchinson, Kansas, 67502
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350
Cancer Center of Kansas-Independence
Independence, Kansas, 67301
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Queens Hospital Center
Jamaica, New York, 11432
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, 72401
Jupiter Medical Center
Jupiter, Florida, 33458
Castle Medical Center
Kailua, Hawaii, 96734
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Beacon Kalamazoo
Kalamazoo, Michigan, 49048
Glacier Oncology PLLC
Kalispell, Montana, 59901
Kalispell Medical Oncology
Kalispell, Montana, 59901
Logan Health Medical Center
Kalispell, Montana, 59901
University of Kansas Cancer Center
Kansas City, Kansas, 66160
University Health Truman Medical Center
Kansas City, Missouri, 64108
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Saint Joseph Health Center
Kansas City, Missouri, 64114
North Kansas City Hospital
Kansas City, Missouri, 64116
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, 64118
Research Medical Center
Kansas City, Missouri, 64132
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Kettering Medical Center
Kettering, Ohio, 45429
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068
ECU Health Oncology Kinston
Kinston, North Carolina, 28501
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916
Community Howard Regional Health
Kokomo, Indiana, 46904
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
AMITA Health Adventist Medical Center
La Grange, Illinois, 60525
IU Health La Porte Hospital
La Porte, Indiana, 46350
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, 03246
Cancer Center of South Florida-Lake Worth
Lake Worth, Florida, 33461
Saint Anthony Hospital
Lakewood, Colorado, 80228
Saint Clare Hospital
Lakewood, Washington, 98499
Doctor's Hospital of Laredo
Laredo, Texas, 78041
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
Northside Hospital - Gwinnett
Lawrenceville, Georgia, 30046
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086
Beebe Medical Center
Lewes, Delaware, 19958
Lewistown Hospital
Lewistown, Pennsylvania, 17044
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905
Liberty Hospital
Liberty, Missouri, 64068
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766
Saint Rita's Medical Center
Lima, Ohio, 45801
Lima Memorial Hospital
Lima, Ohio, 45804
AdventHealth Littleton
Littleton, Colorado, 80122
Logan Regional Hospital
Logan, Utah, 84321
Sky Ridge Medical Center
Lone Tree, Colorado, 80124
Monmouth Medical Center
Long Branch, New Jersey, 07740
Longmont United Hospital
Longmont, Colorado, 80501
Banner McKee Medical Center
Loveland, Colorado, 80539
Texas Tech University Health Sciences Center-Lubbock
Lubbock, Texas, 79430
Manchester Memorial Hospital
Manchester, Connecticut, 06040
Dartmouth Cancer Center - Manchester
Manchester, New Hampshire, 03102
Elliot Hospital
Manchester, New Hampshire, 03103
Solinsky Center for Cancer Care
Manchester, New Hampshire, 03103
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Wellstar Kennestone Hospital
Marietta, Georgia, 30060
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
Bay Area Medical Center
Marinette, Wisconsin, 54143
Contra Costa Regional Medical Center
Martinez, California, 94553-3156
Saint Luke's Hospital
Maumee, Ohio, 43537
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, 43537
Cancer Center of Kansas - McPherson
McPherson, Kansas, 67460
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Garnet Health Medical Center
Middletown, New York, 10940
MyMichigan Medical Center Midland
Midland, Michigan, 48670
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts, 01757
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545
Montana Cancer Specialists
Missoula, Montana, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
Mercy Memorial Hospital
Monroe, Michigan, 48162
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, 48162
Virtua Memorial
Mount Holly, New Jersey, 08060
Skagit Valley Hospital
Mount Vernon, Washington, 98274
El Camino Hospital
Mountain View, California, 94040
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040
Intermountain Medical Center
Murray, Utah, 84107
Nashville Oncology Associates PC
Nashville, Tennessee, 37203
Meharry Medical College
Nashville, Tennessee, 37208
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
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Rutgers New Jersey Medical School
Newark, New Jersey, 07101
Cancer Center of Kansas - Newton
Newton, Kansas, 67114
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
Norwalk Hospital
Norwalk, Connecticut, 06856
Fisher-Titus Medical Center
Norwalk, Ohio, 44857
Sutter Cancer Research Consortium
Novato, California, 94945
Wilma Chan Highland Hospital
Oakland, California, 94602
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609
Bay Area Tumor Institute
Oakland, California, 94609
Hematology and Oncology Associates-Oakland
Oakland, California, 94609
Tom K Lee Inc
Oakland, California, 94609
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
McKay-Dee Hospital Center
Ogden, Utah, 84403
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Cancer Care Associates
Oklahoma City, Oklahoma, 73120
Integris Cancer Institute of Oklahoma
Oklahoma City, Oklahoma, 73142
Providence - Saint Peter Hospital
Olympia, Washington, 98506-5166
Saint Joseph Hospital - Orange
Orange, California, 92868
Saint Charles Hospital
Oregon, Ohio, 43616
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, 43616
AdventHealth Orlando
Orlando, Florida, 32803
About this study
Official title: Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer
This randomized phase II trial studies how well paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine whether adding bevacizumab to neoadjuvant weekly paclitaxel (+/- carboplatin) and subsequent dose-dense doxorubicin and cyclophosphamide (ddAC) significantly raises the rate of pathologic complete response (pCR) in the breast in patients with hormone receptor (HR)-poor/human epidermal growth factor receptor 2 (HER2) (-), resectable breast cancer.
II. To determine whether adding carboplatin every 3 weeks to neoadjuvant weekly paclitaxel followed by ddAC (+/- bevacizumab) significantly raises the rate of pCR in the breast in patients with HR-poor/HER2(-), resectable breast cancer.
III. To determine whether adding bevacizumab every 2 weeks to neoadjuvant weekly paclitaxel (+/- carboplatin) and subsequent ddAC significantly raises the rate of pCR in the breast in patients with basal-like breast cancers, as defined by gene expression array.
IV. To determine whether adding carboplatin every 3 weeks to neoadjuvant weekly paclitaxel followed by ddAC (+/- bevacizumab) significantly raises the rate of pCR in the breast in patients with basal-like breast cancers, as defined by gene expression array.
SECONDARY OBJECTIVES:
- To determine the pCR rates in the breast and axilla, using American Joint Committee On Cancer (AJCC) TNM criteria (version 6), to neoadjuvant weekly paclitaxel, with or without carboplatin, followed by ddAC, with or without bevacizumab, given concurrently with the weekly paclitaxel and ddAC, in (a) patients with HR-poor/HER2(-), resectable breast cancer and (b) the subset of patients with basal-like breast cancers, as defined by gene expression array.
II. To assess whether there is an interaction between the addition of carboplatin and bevacizumab to neoadjuvant chemotherapy (NAC) with weekly paclitaxel followed by ddAC as regards the path pCR rates in (a) patients with HR-poor/HER2(-), resectable breast cancer and (b) the subset of patients with basal-like breast cancers, as defined by gene expression array.
III. To assess the toxicity of the control regimen (weekly paclitaxel followed by ddAC) and any incremental toxicities associated with the addition of carboplatin and/or bevacizumab in this patient population, including the incidence of febrile neutropenia, grade >= 3 thrombocytopenia, grade >= 2 neurotoxicity, grade >= 3 hypertension, and clinically significant bleeding or thrombotic (including cardiovascular and cerebrovascular) events.
IV. To determine the recurrence-free survival (RFS) measured from definitive surgery to first event, and time to first failure (TFF) measured from study entry to first event.
- To determine overall survival (OS), defined as time from registration to death from any cause.
VI. To assess the impact of NAC with weekly paclitaxel followed by ddAC, with or without carboplatin and/or bevacizumab, on axillary lymph node involvement at surgery, particularly in patients with clinically or histologically positive axillary lymph nodes prior to initiation of NAC.
VII. To assess the impact of the addition of bevacizumab to NAC on the incidence and severity of post-op complications, especially excessive bleeding, delayed wound healing, and thrombotic complications.
VIII. To evaluate residual cancer burden (RCB) as a predictor of RFS, TFF and OS.
IX. To determine the correlation between clinical, radiographic, and pathologic response.
TERTIARY OBJECTIVES:
- To assess whether the impact of the addition of carboplatin and/or bevacizumab to NAC with weekly paclitaxel followed by ddAC on achievement of pathologic CRs in patients with HR-poor/HER2(-), resectable breast cancer is influenced by molecular subtype, as defined by gene expression array.
II. To obtain blood, fresh frozen and fixed tumor tissue to test specific hypotheses for which biomarker data exist and to evaluate biomarkers in tissue, blood, and serum that may influence response to and toxicity of weekly paclitaxel, ddAC, carboplatin, and/or bevacizumab.
III. To obtain blood samples to test specific hypotheses for which biomarker data exist and to evaluate biomarkers in blood that may influence response to and toxicity of weekly paclitaxel, ddAC, carboplatin and/or bevacizumab.
IV. To determine the surgical practice patterns for breast conservation and sentinel lymphadenectomy in patients undergoing neoadjuvant chemotherapy.
- To examine the practice patterns and use of sentinel lymphadenectomy (pre-chemotherapy or post-chemotherapy) in patients with T2 or T3 breast cancer.
VI. To examine the proportion of patients who presented with T2 or T3 cancers who undergo mastectomy despite cytoreduction adequate for breast conservation.
VII. To determine the radiotherapy practice patterns for post-mastectomy and regional nodal irradiation in patients undergoing neoadjuvant chemotherapy.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive paclitaxel intravenously (IV) over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 3-10 minutes and cyclophosphamide IV over 5-60 minutes (ddAC) once in weeks 13, 15, 17, and 19.
ARM II: Patients receive paclitaxel and ddAC as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes once in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.
ARM III: Patients receive paclitaxel and ddAC as in Arm I. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
ARM IV: Patients receive paclitaxel and ddAC as in Arm I, bevacizumab as in Arm II, and carboplatin as in Arm III.
Patients in all arms undergo definitive surgery (i.e., modified radical mastectomy or breast-conserving surgery with appropriate management of the axilla) between 4-8 weeks after completion of neoadjuvant therapy.
After completion of study treatment, patients are followed up periodically for up to 10 years.
- Conditions
- Male Breast Carcinoma, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IIIA Breast Cancer AJCC v7, Triple-Negative Breast Carcinoma
- Being tested
- Bevacizumab, Carboplatin, Cyclophosphamide, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis
- Medical subject headings
- Breast Neoplasms, Male, Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabBiological
Also called ABP 215, ABP-215, ABP215, Alymsys
Given IV
CarboplatinDrug
Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino
Given IV
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518
Given IV
Also called 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (paclitaxel, doxorubicin, cyclophosphamide) | Active comparator | Patients receive paclitaxel IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19. Receives: Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel |
| Arm II (paclitaxel, ddAC, bevacizumab) | Experimental | Patients receive paclitaxel and ddAC as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17. Receives: Biological: Bevacizumab; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel |
| Arm III (paclitaxel, ddAC, carboplatin) | Experimental | Patients receive paclitaxel and ddAC as in Arm I. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10. Receives: Drug: Carboplatin; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel |
| Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin) | Experimental | Patients receive paclitaxel and ddAC as in Arm I, bevacizumab as in Arm II, and carboplatin as in Arm III. Receives: Biological: Bevacizumab; Drug: Carboplatin; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).
Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain carboplatin (arms 3\&4) versus not (arms 1\&2) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.
Measured: At the time of definitive surgical removal, up to 28 weeks
Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).
Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain bevacizumab (arms 2\&4) versus not (arms 1\&3) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.
Measured: At the time of definitive surgical removal, up to 28 weeks
Secondary outcomes (9)
Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).
Comparing regimens that contain carboplatin (arms 3\&4) versus not (arms 1\&2).
Measured: At the time of definitive surgical removal, up to 28 weeks
Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).
Comparing regimens that contain bevacizumab (arms 2\&4) versus not (arms 1\&3).
Measured: At the time of definitive surgical removal, up to 28 weeks
Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6)
Stage II is (T2,T3, N0, M0) tumor size more than 2 cm but no deep extradermal structure invasion, no regional lymph node metastasis, and no distant metastasis. Stage III is (T4, N0, M0) tumor invasion of deep extradermal structures, no regional lymph node metasis, and no distant metasasis or (Any T, N1, M0) Any tumor size, regional lymph node metastasis, and no distant metastasis.
Measured: at definitive surgery, up to 28 weeks
Radiographic Response Assessed by Tumor Measurement
Assessed by RECIST, each patient will have a pre-therapy baseline radiographic tumor measurement, preferably by MRI, however if logistic or practical or financial issues preclude MRI use, mammogram or ultrasound may be substituted. The longest diameter (LD) of the target lesion at the time of study initiation will be reported as the baseline LD. The baseline LD of the target lesion will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease. Radiographic complete response: Disappearance of the target lesion. Radiographic partial response (PR): At least a 30% decrease in the longest diameter (LD) of the target lesion taking as reference the baseline LD.
Measured: Baseline; at completion of neoadjuvant therapy
Clinical Response Assessed by Tumor Measurement
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST). Both target and, in the event of multifocal or multicentric invasive breast cancer, nontarget lesions should be followed clinically and their clinical size recorded at aseline. Measurements thereafter are required at the completion of 12 weeks of paclitaxel or paclitaxel/carboplatin and at the completion of all neoadjuvant chemotherapy. At any time point, these lesions should be categorized regarding whether there is evidence of progression. If "yes", the study chair should be notified in order to determine whether the patient should come off protocol treatment. In-situcarcinoma does not represent a non-target lesion and should not be recorded or followed.
Measured: Baseline; at completion of neoadjuvant therapy
Overall Survival
Number of Participants who Died Due to Any Cause
Measured: up to 10 years
Recurrence-free Survival
From definitive surgery to first instance of ipsilateral invasive breast tumor recurrence, local/regional invasive breast cancer recurrence, distant recurrence, or death from any cause. Number of Participants who Died Due to Any Cause or had a recurrence.
Measured: up to 10 years
Count of Participants With a First Failure, Defined as First Instance of Ipsilateral Invasive Breast Tumor Recurrence, Local/Regional Invasive Breast Cancer Recurrence, Distant Recurrence, or Death From Any Cause
From study entry to first event.
Measured: up to 10 years
Incidence and Severity of Post-op Complications, Namely Excessive Bleeding, Delayed Wound Healing, and Wound Dehiscence.
Assessed by physician observation.
Measured: at definitive surgery, up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study start21 Jul 2009
- Primary completion1 Aug 2014
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Male Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- William M Sikov, Principal investigator, Alliance for Clinical Trials in Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861705
- Sponsor's protocol ID
- NCI-2009-01172
- Other IDs
- NCI-2009-01172, CALGB 40603/CTSU 40603, CALGB-40603, CDR0000636850, CALGB 40603, CALGB-40603, U10CA180821, U10CA031946
- Status last verified
- Jun 2026
- First submitted
- 12 Mar 2009
- Last updated
- 29 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Publications
Radler PD, Felsheim BM, Fernandez-Martinez A, Pfefferle AD, Hayward MC, Singh B, Sikov W, Carey LA, Perou CM. Molecular evaluation of residual disease following neoadjuvant chemotherapy in triple negative breast cancer CALGB40603 (Alliance). J Clin Invest. 2026 Aug 4:e205962. doi: 10.1172/JCI205962. Online ahead of print.
PubMed 42550611Shepherd JH, Ballman K, Polley MC, Campbell JD, Fan C, Selitsky S, Fernandez-Martinez A, Parker JS, Hoadley KA, Hu Z, Li Y, Soloway MG, Spears PA, Singh B, Tolaney SM, Somlo G, Port ER, Ma C, Kuzma C, Mamounas E, Golshan M, Bellon JR, Collyar D, Hahn OM, Hudis CA, Winer EP, Partridge A, Hyslop T, Carey LA, Perou CM, Sikov WM. CALGB 40603 (Alliance): Long-Term Outcomes and Genomic Correlates of Response and Survival After Neoadjuvant Chemotherapy With or Without Carboplatin and Bevacizumab in Triple-Negative Breast Cancer. J Clin Oncol. 2022 Apr 20;40(12):1323-1334. doi: 10.1200/JCO.21.01506. Epub 2022 Jan 19.
PubMed 35044810Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol. 2015 Jan 1;33(1):13-21. doi: 10.1200/JCO.2014.57.0572. Epub 2014 Aug 4.
PubMed 25092775