Trial record 1 of 67 for:    S0800
Previous Study | Return to List | Next Study

S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00856492
First received: March 4, 2009
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, 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. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which treatment regimen is more effective in treating women with breast cancer.

PURPOSE: This randomized phase II trial is studying paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin, cyclophosphamide, and pegfilgrastim to compare how well they work when given with or without bevacizumab in treating women with inflammatory or locally advanced breast cancer.


Condition Intervention Phase
Breast Cancer
Biological: bevacizumab
Biological: pegfilgrastim
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A)and Cyclophosphamide (C) Plus Pegfilgrastim (PEG-G) as Neoadjuvant Therapy For Inflammatory and Locally Advanced HER-2/NEU Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Pathological complete response rate [ Time Frame: pre-study pathology vs. post chemo surgery pathology ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration. ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: Assessed every 4 weeks while on treatment. ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration or until recurrence ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
Biological: bevacizumab
Given IV
Biological: pegfilgrastim
Given subcutaneously
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IV
Active Comparator: Arm II
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
Biological: pegfilgrastim
Given subcutaneously
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IV
Active Comparator: Arm III
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.
Biological: pegfilgrastim
Given subcutaneously
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IV

Detailed Description:

OBJECTIVES:

  • To compare the pathologic complete response rates in women with HER2/neu-negative inflammatory or locally advanced breast cancer treated with paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin hydrochloride, cyclophosphamide, and pegfilgrastim with vs without bevacizumab.
  • To compare the overall survival of patients treated with these regimens.
  • To assess whether there is a correlation between bevacizumab and stratification factors (type of disease and hormone receptor status).
  • To compare the toxicities of these regimens.
  • To explore the molecular biomarkers related to the biology and outcome of inflammatory breast cancer.
  • To explore potential molecular biomarkers that predict response to therapy and drug sensitivity.
  • To evaluate biomarkers with respect to the sequence of paclitaxel albumin-stabilized nanoparticle formulation and doxorubicin hydrochloride/cyclophosphamide/pegfilgrastim administration in patients not receiving bevacizumab.
  • To explore residual cancer burden and correlate it with outcome.
  • To evaluate the time to treatment failure prior to surgery.
  • To evaluate disease-free survival from the time of surgery in patients undergoing definitive surgery.

OUTLINE: This is a multicenter study. Patients are stratified according to type of disease (inflammatory vs locally advanced breast cancer) and hormone receptor status (positive [estrogen receptor (ER)+ and/or progesterone receptor (PgR)+] vs negative [ER- and PgR-]). Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
  • Arm II: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
  • Arm III: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.

In all arms, patients with stable or responding disease undergo surgery 3-6 weeks after completion of chemotherapy. Patients may then undergo radiotherapy 5 days a week for 6 weeks.

Serum, whole blood, and tissue samples are collected periodically for biomarker analysis, circulating endothelial cell analysis, and pharmacogenomic studies, respectively.

After completion of study treatment, patients are followed every 6 months for 1 year and then annually for 4 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or pathologically confirmed breast cancer meeting one of the following criteria:

    • Locally advanced disease (stage IIIB disease, stage IIB/IIIA, or stage IIIC disease)
    • Inflammatory disease meeting the following two clinicopathologic criteria:

      • Diffuse erythema AND edema (peau d'orange) of the breast involving the majority of the skin of the breast, i.e., more than 50%
      • A biopsy demonstrating cancer either within the dermal lymphatics OR in the breast parenchyma itself
  • HER2/neu-negative tumor as demonstrated by 0 or 1+ (weak or no staining) by DAKO, IHC, or equivalent test OR no gene amplification by FISH*

    • 2+ by DAKO or IHC allowed provided FISH* negative
  • NOTE: *A negative FISH test ratio is < 1.8 or FISH HER2 gene copy < 4.0; if only a positive or negative result is available from the FISH test, a negative result is acceptable for study entry
  • Hormone receptor status known

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • Zubrod performance status 0-2
  • Granulocyte count > 1,500/mm^3
  • ANC ≥ 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin 9.0 g/dL
  • Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 mg/dL
  • ALT and AST ≤ 3 times ULN
  • Alkaline phosphatase ≤ 2.5 ULN (unless bone metastasis is present in the absence of liver metastasis)
  • Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg on 24-hour urine collection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to take oral medications (e.g., no uncontrolled nausea, vomiting, or diarrhea, lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome)
  • QTc < 500 msec by EKG
  • LVEF normal by MUGA or ECHO (for patients with hypertension or for patients > 60 years of age)
  • NYHA class II cardiac function by baseline ECHO/MUGA (for patients who have received central thoracic radiotherapy that included the heart in the radiotherapy port, or for patients who have a history of class II heart failure but are asymptomatic on treatment are eligible)
  • No history of stroke (cerebrovascular accident), transient ischemic attack, or cardiac event within the past 12 months, including any of the following:

    • Myocardial infarction (including severe/unstable angina)
    • Coronary/peripheral artery bypass graft
    • Symptomatic congestive heart failure
    • Pulmonary embolism
  • No poorly controlled hypertension, defined as recurrent or persistent (≥ 24 hours) elevated blood pressure (i.e., systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg)
  • No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • Peripheral neuropathy < grade 2

PRIOR CONCURRENT THERAPY:

  • No prior tyrosine kinase inhibitors
  • More than 5 years since prior chemotherapy, radiotherapy, or biologic therapy (e.g., trastuzumab or bevacizumab) for invasive breast cancer
  • At least 7 days since prior hormonal therapy
  • At least 7 days since prior and no concurrent strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or grapefruit juice
  • No concurrent CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's wort)
  • No other concurrent therapy for the treatment of breast cancer except for bisphosphonates
  • No concurrent brachytherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856492

  Hide Study Locations
Locations
United States, Alabama
Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States, 36608
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
Peninsula Medical Center
Burlingame, California, United States, 94010
Valley Medical Oncology Consultants - Castro Valley
Castro Valley, California, United States, 94546
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546
Valley Medical Oncology
Fremont, California, United States, 94538
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
Marysville, California, United States, 95901
El Camino Hospital Cancer Center
Mountain View, California, United States, 94040
Sutter Health - Western Division Cancer Research Group
Novato, California, United States, 94945
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Highland General Hospital
Oakland, California, United States, 94602
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
Tom K Lee, Incorporated
Oakland, California, United States, 94609
Larry G Strieff MD Medical Corporation
Oakland, California, United States, 94609
Bay Area Breast Surgeons, Incorporated
Oakland, California, United States, 94609
Epic Care - Oakland
Oakland, California, United States, 94612
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States, 92868
Desert Regional Medical Center Comprehensive Cancer Center
Palm Springs, California, United States, 92262
Valley Medical Oncology Consultants - Pleasanton
Pleasanton, California, United States, 94588
University of California Davis Cancer Center
Sacramento, California, United States, 95817
California Pacific Medical Center - California Campus
San Francisco, California, United States, 94118
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States, 94806
Sutter Pacific Medical Foundation
Santa Rosa, California, United States, 95403
Tahoe Forest Cancer Center
Truckee, California, United States, 96161
Sutter Solano Medical Center
Vallejo, California, United States, 94589
United States, Colorado
San Luis Valley Regional Medical Center
Alamosa, Colorado, United States, 81101
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
Memorial Hospital Cancer Center - Colorado Springs
Colorado Springs, Colorado, United States, 80909
Shaw Regional Cancer Center
Edwards, Colorado, United States, 81632
Valley View Hospital Cancer Center
Glenwood Springs, Colorado, United States, 81601
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
Montrose Memorial Hospital Cancer Center
Montrose, Colorado, United States, 81401
United States, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States, 33458
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Georgia
Phoebe Cancer Center at Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31701
Northeast Georgia Cancer Care, LLC - Medical Oncology
Athens, Georgia, United States, 30607
Piedmont Hospital
Atlanta, Georgia, United States, 30309
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342-1701
Northside Hospital Cancer Center
Atlanta, Georgia, United States, 30342-1611
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912
WellStar Cobb Hospital
Austell, Georgia, United States, 30106
John B. Amos Cancer Center
Columbus, Georgia, United States, 31904
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States, 30033
Piedmont Fayette Hospital
Fayetteville, Georgia, United States, 30214
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274-2600
Harbin Clinic Cancer Center - Medical Oncology
Rome, Georgia, United States, 30165
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Hawaii
Kapiolani Medical Center at Pali Momi
Aiea, Hawaii, United States, 96701
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii, United States, 96813
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States, 96813
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, United States, 96817
Hawaii Medical Center - East
Honolulu, Hawaii, United States, 96817
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, United States, 96813
Castle Medical Center
Kailua, Hawaii, United States, 96734
Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
Maui Memorial Medical Center
Wailuku, Hawaii, United States, 96793
Pacific Cancer Institute - Maui
Wailuku, Hawaii, United States, 96793
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
St. Joseph Regional Medical Center
Lewiston, Idaho, United States, 83501
United States, Illinois
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare - Bloomington
Bloomington%, Illinois, United States, 61701
Graham Hospital
Canton, Illinois, United States, 61520
Illinois CancerCare - Canton
Canton, Illinois, United States, 61520
Illinois CancerCare - Carthage
Carthage, Illinois, United States, 62321
Memorial Hospital
Carthage, Illinois, United States, 62321
Resurrection Medical Center
Chicago, Illinois, United States, 60631
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Illinois CancerCare - Eureka
Eureka, Illinois, United States, 61530
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare - Galesburg
Galesburg, Illinois, United States, 61401
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Mason District Hospital
Havana, Illinois, United States, 62644
Illinois CancerCare - Havana
Havana, Illinois, United States, 62644
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, United States, 61443
McDonough District Hospital
Macomb, Illinois, United States, 61455
Illinois CancerCare - Macomb
Macomb, Illinois, United States, 61455
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Illinois CancerCare - Monmouth
Monmouth, Illinois, United States, 61462
OSF Holy Family Medical Center
Monmouth, Illinois, United States, 61462
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center
Normal, Illinois, United States, 61761
Illinois CancerCare - Community Cancer Center
Normal, Illinois, United States, 61761
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Illinois CancerCare - Pekin
Pekin, Illinois, United States, 61603
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Proctor Hospital
Peoria, Illinois, United States, 61614
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Illinois CancerCare - Peru
Peru, Illinois, United States, 61354
Illinois CancerCare - Princeton
Princeton, Illinois, United States, 61356
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, United States, 61362
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46845
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51102
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Saint Luke's Hospital - South
Overland Park, Kansas, United States, 66213
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
CCOP - Kansas City
Prairie Village, Kansas, United States, 66208
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
CCOP - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, United States, 21204
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Bay Regional Medical Center
Bay City, Michigan, United States, 48708
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
McLaren Cancer Institute
Flint, Michigan, United States, 48532
Singh and Arora Hematology Oncology, PC
Flint, Michigan, United States, 48532
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Dickinson County Healthcare System
Iron Mountain, Michigan, United States, 49801
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
Great Lakes Cancer Institute - Lapeer Campus
Lapeer, Michigan, United States, 48446
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
MidMichigan Medical Center - Midland
Midland, Michigan, United States, 48670
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
Clemens Regional Medical Center
Mount Clemens, Michigan, United States, 48043
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States, 48075
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Minnesota Oncology - Maplewood
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology - Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
St. John's Regional Medical Center
Joplin, Missouri, United States, 64804
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Heartland Hematology Oncology Associates, Incorporated
Kansas City, Missouri, United States, 64118
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Parvin Radiation Oncology
Liberty, Missouri, United States, 64068
Phelps County Regional Medical Center
Rolla, Missouri, United States, 65401
Saint Joseph Oncology, Incorporated
Saint Joseph, Missouri, United States, 64507
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59102
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
Big Sky Oncology
Great Falls, Montana, United States, 59405-5309
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
St. Peter's Hospital
Helena, Montana, United States, 59601
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
United States, New Jersey
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
Albuquerque, New Mexico, United States, 87110
University of New Mexico Cancer Center - South
Las Cruces, New Mexico, United States, 88011
United States, New York
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States, 12801
Nalitt Cancer Institute at Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Kinston Medical Specialists
Kinston, North Carolina, United States, 28501
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Barberton Citizens Hospital
Barberton, Ohio, United States, 44203
Cleveland Clinic Beachwood Family Health and Surgery Center
Beachwood, Ohio, United States, 44122
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
CCOP - Columbus
Columbus, Ohio, United States, 43215
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Grandview Hospital
Dayton, Ohio, United States, 45405
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
CCOP - Dayton
Dayton, Ohio, United States, 45420
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Community Cancer Center
Elyria, Ohio, United States, 44035
Hematology Oncology Center
Elyria, Ohio, United States, 44035
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Cleveland Clinic Cancer Center
Independence, Ohio, United States, 44131
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537-1839
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Parma Community General Hospital
Parma, Ohio, United States, 44129
Southern Ohio Medical Center Cancer Center
Portsmouth, Ohio, United States, 45662
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Cleveland Clinic Foundation - Strongsville
Strongsville, Ohio, United States, 44136
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
St. Anne Mercy Hospital
Toledo, Ohio, United States, 43623
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Toledo Hospital
Toledo, Ohio, United States, 43606
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Cleveland Clinic - Wooster
Wooster, Ohio, United States, 44691
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
United States, Oregon
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland, Oregon, United States, 97210
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States, 97227
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, United States, 19464
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
United States, South Carolina
AnMed Cancer Center
Anderson, South Carolina, United States, 29621
McLeod Regional Medical Center
Florence, South Carolina, United States, 29501
Bon Secours St. Francis Health System
Greenville, South Carolina, United States, 29601
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Erlanger Cancer Center at Erlanger Hospital - Baroness
Chattanooga, Tennessee, United States, 37403
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States, 37662
United States, Texas
Doctor's Hospital of Laredo
Laredo, Texas, United States, 78045
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Utah
American Fork Hospital
American Fork, Utah, United States, 84003
Sandra L. Maxwell Cancer Center
Cedar City, Utah, United States, 84720
Logan Regional Hospital
Logan, Utah, United States, 84321
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States, 84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Virginia
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
Southwest Virginia Regional Cancer Center at Wellmonth Health
Norton, Virginia, United States, 24273
United States, Washington
Island Hospital Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
Overlake Cancer Center at Overlake Hospital Medical Center
Bellevue, Washington, United States, 98004
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Highline Medical Center Cancer Center
Burien, Washington, United States, 98166
Providence Centralia Hospital
Centralia, Washington, United States, 98531-9027
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
St. Francis Hospital
Federal Way, Washington, United States, 98003
Swedish Medical Center - Issaquah Campus
Issaquah, Washington, United States, 98029
Columbia Basin Hematology
Kennewick, Washington, United States, 99336
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, United States, 98274
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States, 98506-5166
Harrison Poulsbo Hematology and Onocology
Poulsbo, Washington, United States, 98370
Good Samaritan Cancer Center
Puyallup, Washington, United States, 98372
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195
Group Health Central Hospital
Seattle, Washington, United States, 98112
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Harborview Medical Center
Seattle, Washington, United States, 98104
Polyclinic First Hill
Seattle, Washington, United States, 98122
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, United States, 98284
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Evergreen Hematology and Oncology, PS
Spokane, Washington, United States, 99218
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States, 99204
Allenmore Hospital
Tacoma, Washington, United States, 98405
Franciscan Cancer Center at St. Joseph Medical Center
Tacoma, Washington, United States, 98405-3004
St. Clare Hospital
Tacoma, Washington, United States, 98499
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States, 98405
CCOP - Northwest
Tacoma, Washington, United States, 98405
Legacy Salmon Creek Medical Center
Vancouver, Washington, United States, 98686
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801-2028
United States, Wisconsin
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, United States, 54221-1450
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
St. Nicholas Hospital
Sheboygan, Wisconsin, United States, 53081
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Puerto Rico
San Juan City Hospital
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Principal Investigator: Zeina Nahleh, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00856492     History of Changes
Other Study ID Numbers: CDR0000636131, S0800, U10CA032102
Study First Received: March 4, 2009
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
inflammatory breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
HER2-negative breast cancer
estrogen receptor-negative breast cancer
estrogen receptor-positive breast cancer
progesterone receptor-negative breast cancer
progesterone receptor-positive breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Bevacizumab
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Paclitaxel
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014