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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 (C) Plus Pegfilgrastim (PEG-G) as Neoadjuvant Therapy For Inflammatory and Locally Advanced HER-2/NEU Negative Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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


- 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

- 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

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.

Inclusion Criteria


- Histologically or pathologically confirmed breast cancer meeting one of the following

- Locally advanced disease (stage IIIB disease, stage IIB/IIIA, or stage IIIC

- 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


- 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

- 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

- 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


- 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

- No concurrent brachytherapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological complete response rate

Outcome Time Frame:

pre-study pathology vs. post chemo surgery pathology

Safety Issue:


Principal Investigator

Zeina Nahleh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

April 2010

Completion Date:

December 2016

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms



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University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Valley Medical Oncology Consultants - Castro Valley Castro Valley, California  94546
Valley Medical Oncology Fremont, California  94538
Memorial Hospital Cancer Center - Colorado Springs Colorado Springs, Colorado  80909
Minnesota Oncology - Maplewood Maplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
Lakeview Hospital Stillwater, Minnesota  55082
Minnesota Oncology - Woodbury Woodbury, Minnesota  55125
CCOP - Kansas City Prairie Village, Kansas  66208
Erlanger Cancer Center at Erlanger Hospital - Baroness Chattanooga, Tennessee  37403
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center Burbank, California  91505
Shaw Regional Cancer Center Edwards, Colorado  81632
San Luis Valley Regional Medical Center Alamosa, Colorado  81101
Valley View Hospital Cancer Center Glenwood Springs, Colorado  81601
Piedmont Fayette Hospital Fayetteville, Georgia  30214
Castle Medical Center Kailua, Hawaii  96734
Kauai Medical Clinic Lihue, Hawaii  96766
Clemens Regional Medical Center Mount Clemens, Michigan  48043
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital Albuquerque, New Mexico  87110
University of New Mexico Cancer Center - South Las Cruces, New Mexico  88011
Cleveland Clinic Beachwood Family Health and Surgery Center Beachwood, Ohio  44122
Cleveland Clinic Foundation - Strongsville Strongsville, Ohio  44136
Island Hospital Cancer Care Center at Island Hospital Anacortes, Washington  98221
Highline Medical Center Cancer Center Burien, Washington  98166
New Ulm Medical Center New Ulm, Minnesota  56073
St. Nicholas Hospital Sheboygan, Wisconsin  53081
Northeast Georgia Cancer Care, LLC - Medical Oncology Athens, Georgia  30607
Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center Long Beach, California  90806
Overlake Cancer Center at Overlake Hospital Medical Center Bellevue, Washington  98004
Southern Ohio Medical Center Cancer Center Portsmouth, Ohio  45662
McLaren Cancer Institute Flint, Michigan  48532
Providence Regional Cancer Partnership Everett, Washington  98201
Cancer Center of Kansas, PA - McPherson McPherson, Kansas  67460
St. Joseph Regional Medical Center Lewiston, Idaho  83501
Swedish Medical Center - Issaquah Campus Issaquah, Washington  98029
Epic Care - Oakland Oakland, California  94612
Singh and Arora Hematology Oncology, PC Flint, Michigan  48532
Great Lakes Cancer Institute - Lapeer Campus Lapeer, Michigan  48446
Sutter Pacific Medical Foundation Santa Rosa, California  95403