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Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer



- Determine the antitumor activity of ABI-007 and gemcitabine, in terms of response rate
in women with metastatic breast cancer.

- Determine the toxicity profile of this regimen, in terms of incidence and severity of
observed toxic effects, in these patients.


* Determine the time to disease progression and survival of patients treated with this

OUTLINE: This is a multicenter study. Patients receive ABI-007 IV over 30 minutes and
gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence
of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for up to 5 years.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 20 months.

Inclusion Criteria


- Histologically or cytologically confirmed invasive breast cancer

- Clinical evidence of metastatic disease

+ No bone metastases or other non-measurable disease as the only evidence of

- Measurable disease, defined as at least 1 measurable lesion

- The following are considered non-measurable disease:

- Small lesions (< 2 cm)

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural or pericardial effusions

- Inflammatory breast disease

- Lymphangitis cutis or pulmonis

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

- Cystic lesions

- HER2(human epidermal growth factor receptor 2)-positive disease allowed provided
patient has received prior treatment with trastuzumab

- No evidence of active brain metastasis, including leptomeningeal involvement

- Hormone receptor status:

- Not specified



- 18 and over Sex

- Female Menopausal status

- Not specified Performance status

- ECOG 0-1 Life expectancy

- At least 12 weeks Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL Hepatic

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN Renal

- Creatinine ≤ 1.5 mg/dL Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after
completion of study treatment

- No pre-existing peripheral neuropathy > grade 1

- No other clinically significant illness or significant medical condition that would
preclude study participation

- No history of allergy or hypersensitivity to paclitaxel protein-bound particles in an
injectable suspension, paclitaxel, gemcitabine, albumin, drug product excipients, or
agents that are chemically similar to study drugs

- No serious medical risk factors involving any of the major organ systems that would
preclude study participation

- No active stage III or IV invasive non-breast malignancy within the past 5 years


Biologic therapy

- See Disease Characteristics Chemotherapy

- No more than 1 prior adjuvant chemotherapy regimen

- No prior chemotherapy for metastatic disease

- At least 6 months since prior adjuvant or neoadjuvant taxane

- More than 2 weeks since prior cytotoxic chemotherapy

- Prior neoadjuvant chemotherapy allowed

- No other concurrent chemotherapy Endocrine therapy

- Prior hormonal treatment as adjuvant therapy or for metastatic disease allowed

- Prior radiotherapy to target lesion allowed provided there is evidence of disease
progression after completion of treatment

- More than 2 weeks since prior radiotherapy, except radiotherapy to a non-target
lesion only or single-dose palliative radiotherapy

- No concurrent radiotherapy Surgery

- Not specified Other

- More than 2 weeks since prior investigational drugs

- No concurrent participation in another clinical trial that is studying
investigational procedures or therapies

- Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed for palliation
of pain or lytic lesions from breast cancer

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of Patients With Confirmed Responses

Outcome Description:

Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart. Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.

Outcome Time Frame:

Two consecutive evaluations at least 6 weeks apart

Safety Issue:


Principal Investigator

Vivek Roy, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

August 2005

Completion Date:

August 2010

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • Breast Neoplasms



Mayo Clinic Rochester, Minnesota  55905
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Aurora Presbyterian Hospital Aurora, Colorado  80012
Boulder Community Hospital Boulder, Colorado  80301-9019
Penrose Cancer Center at Penrose Hospital Colorado Springs, Colorado  80933
Porter Adventist Hospital Denver, Colorado  80210
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
St. Joseph Hospital Denver, Colorado  80218
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
Sky Ridge Medical Center Lone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United Hospital Longmont, Colorado  80502
North Suburban Medical Center Thornton, Colorado  80229
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Seton Cancer Institute - Saginaw Saginaw, Michigan  48601
St. John Macomb Hospital Warren, Michigan  48093
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
CCOP - Duluth Duluth, Minnesota  55805
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Meeker County Memorial Hospital Lichfield, Minnesota  55355
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Rapid City Regional Hospital Rapid City, South Dakota  57709
Methodist Medical Center of Illinois Peoria, Illinois  61636
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
Hinsdale, Illinois  60521
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
St. Vincent Mercy Medical Center Toledo, Ohio  43608
CCOP - Colorado Cancer Research Program, Incorporated Denver, Colorado  80224
Northside Hospital Cancer Center Atlanta, Georgia  30342-1611
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
St. Mary's - Duluth Clinic Cancer Center Duluth, Minnesota  55805
Green Bay Oncology, Limited - Escanaba Escanaba, Michigan  49431
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto Falls Oconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
Siouxland Hematology-Oncology Associates Sioux City, Iowa  51101
Siouxland Regional Cancer Center Sioux City, Iowa  51101-1733
Cancer Center of Kansas, P.A. - El Dorado El Dorado, Kansas  67042
Southwest Medical Center Liberal, Kansas  67901
Cancer Center of Kansas, P.A. - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, P.A. - Wichita Wichita, Kansas  67214
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
St. Mary-Corwin Regional Medical Center Pueblo, Colorado  81004
Saint Joseph's Hospital of Atlanta Atlanta, Georgia  30342-1701
Piedmont Hospital Atlanta, Georgia  30309
WellStar Cobb Hospital Austell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur, Georgia  30033
Gwinnett Medical Center Lawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta, Georgia  30060
Southern Regional Medical Center Riverdale, Georgia  30274-2600
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
Galesburg Clinic Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
Kewanee Hospital Kewanee, Illinois  61443
McDonough District Hospital Macomb, Illinois  61455
Trinity Medical Center - East Moline, Illinois  61265
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Margaret's Hospital Spring Valley, Illinois  61362
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
McFarland Clinic, P. C. Ames, Iowa  50010
Bettendorf, Iowa  52722
St. Luke's Hospital Cedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids, Iowa  52403
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Capitol Hospital Des Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des Moines West Des Moines, Iowa  50266
Cancer Center of Kansas, P.A. - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas, P.A. - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, P.A. - Newton Newton, Kansas  67114
Cancer Center of Kansas, P.A. - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, P.A. - Salina Salina, Kansas  67042
Cancer Center of Kansas, P.A. - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, P.A. - Medical Arts Tower Wichita, Kansas  67208
Associates in Womens Health, P.A. - North Review Wichita, Kansas  67203
Cancer Center of Kansas, P.A. - Winfield Winfield, Kansas  67156
Hickman Cancer Center at Bixby Medical Center Adrian, Michigan  49221
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital Ann Arbor, Michigan  48106-0995
Green Bay Oncology, Limited - Iron Mountain Iron Mountain, Michigan  49801
Haematology-Oncology Associates of Ohio and Michigan, P.C. Lambertville, Michigan  48144
Community Cancer Center of Monroe Monroe, Michigan  48162
Mercy Memorial Hospital System Monroe, Michigan  48162
Alexandria, Minnesota  56308
MeritCare Clinic - Bemidji Bemidji, Minnesota  56601
Brainerd Medical Center Brainerd, Minnesota  56401
St. Joseph's Medical Center Brainerd, Minnesota  56401
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Chippewa County - Montevideo Hospital Montevideo, Minnesota  56265
Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale, Minnesota  55422-2900
Coborn Cancer Center Saint Cloud, Minnesota  56303
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Park Nicollet Health Services St. Louis Park, Minnesota  55416
Cancer Care Center at Medcenter One Hospital Bismarck, North Dakota  58501
Bismarck Cancer Center Bismarck, North Dakota  58501
St. Alexius Medical Center Bismarck, North Dakota  58502
Mid Dakota Clinic, P. C. Bismarck, North Dakota  58501
MeritCare Medical Group Fargo, North Dakota  58122
Wood County Oncology Center Bowling Green, Ohio  43402
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Fremont Memorial Hospital Fremont, Ohio  43420
Kenton Oncology, Incorporated Kenton, Ohio  43326
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
Middletown Regional Hospital Middletown, Ohio  45044
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Firelands Regional Medical Center Sandusky, Ohio  44870
Promedica Cancer Center at Flower Hospital Sylvania, Ohio  43560
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
Toledo Surgical Specialists Toledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Fulton County Health Center Wauseon, Ohio  43567
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Green Bay Oncology, Limited at St. Vincent Hospital Green Bay, Wisconsin  54301-3526
Rose Ramer Cancer Clinic at Anderson Area Medical Center Anderson, South Carolina  29621
Miller-Dwan Medical Center Duluth, Minnesota  55805
Geisinger Medical Group State College, Pennsylvania  16801
Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City, Iowa  50401
Saint Francis Cancer Center Shakopee, Minnesota  55379
St. Joseph's Hospital St Paul, Minnesota  55102
Cancer Resource Center - Lincoln Lincoln, Nebraska  68510
Altru Cancer Center at Altru Hospital Grand Forks, North Dakota  58201
St. Francis Medical Center Honolulu, Hawaii  96817
Queen's Cancer Institute at Queen's Medical Center Honolulu, Hawaii  96813
Immanuel St. Joseph's Clinic Mankato, Minnesota  56002
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Mayo Clinic in Arizona Scottsdale, Arizona  85259-5404
Mayo Clinic in Florida Jacksonville, Florida  32224
Woodwinds Health Campus Woodbury, Minnesota  55125
Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Straub Clinic and Hospital, Incorporated Honolulu, Hawaii  96813
OnCare Hawaii, Incorporated - Kuakini Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Lusitana Honolulu, Hawaii  96813
United States Air Force Medical Center Wright-Patterson Wright-Patterson Afb, Ohio  45433-5529
Ottumwa Regional Health Center Cancer Center Ottumwa, Iowa  52501