Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:April 2010

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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 ©) PLUS PEGFILGRASTIM (PEG-G) AS NEOADJUVANT THERAPY FOR INFLAMMATORY AND LOCALLY ADVANCED HER-2/NEU NEGATIVE BREAST CANCER


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.


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.

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
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Carthage, Illinois 62321
(217) 357-8500
Memorial Hospital Memorial Hospital is a vital force in establishing and maintaining the well-being of...
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Carthage, IL
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160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Carthage, IL
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6501 E 2nd St
Casper, Wyoming 82609
(307) 235-5433
Rocky Mountain Oncology Rocky Mountain Oncology Center is a spacious, comfortable, state-of-the-art 19,000 square foot...
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Casper, WY
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20126 Stanton Ave
Castro Valley, California 94546
(510) 581-0556
East Bay Radiation Oncology Center East Bay Radiation Oncology Center offers superior medical and technical...
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Castro Valley, CA
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20055 Lake Chabot Rd #130
Castro Valley, California 94546
(510) 888-0657
Valley Medical Oncology Consultants - Castro Valley Valley Medical Oncology Consultants (VMOC) has been helping...
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Castro Valley, CA
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1303 North Main Street
Cedar City, Utah 84721
(435) 868-5680
Sandra L. Maxwell Cancer Center The Huntsman-Intermountain Cancer Center at Valley View Medical Center in...
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Cedar City, UT
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914 S Scheuber Rd
Centralia, Washington 98531
(360) 736-2803
Providence Centralia Hospital We are a 127-bed, not for profit hospital providing emergency, diagnostic, cancer,...
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Centralia, WA
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505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Chanute, KS
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Chattanooga, TN
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Chicago, Illinois 60631
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Chicago, IL
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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Chillicothe, OH
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18101 Lorain Avenue
Cleveland, Ohio 44111
216.476.7000
Cleveland Clinic Cancer Center at Fairview Hospital Fairview Hospital is a 488-bed hospital located at...
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Cleveland, OH
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Colorado Springs, Colorado 80909
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Colorado Springs, CO
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1831 Fifth Avenue
Columbus, Georgia 31904
(706) 320-8700
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
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Columbus, GA
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