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A Phase II Study of Carboplatin, Nanoparticle Albumin-Bound Paclitaxel (ABI-007) and Avastin as the First Line Therapy in Metastatic Breast Cancer.

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

A Phase II Study of Carboplatin, Nanoparticle Albumin-Bound Paclitaxel (ABI-007) and Avastin as the First Line Therapy in Metastatic Breast Cancer.



- To determine the progression-free survival of patients with locally recurrent or
metastatic breast cancer treated with carboplatin, paclitaxel albumin-stabilized
nanoparticle formulation, and bevacizumab as first-line therapy.


- To determine the response rate in these patients.

- To determine the overall survival of these patients.

- To evaluate the toxicity profile of this regimen in these patients.

OUTLINE: Patients receive carboplatin IV over 1 hour and bevacizumab IV on days 1, 22 and
43. Patients also receive paclitaxel albumin-bound nanoparticle formulation IV over 30
minutes on days 1, 8 ,15, 22, 29, 36, 43, and 50. Treatment continues in the absence of
disease progression or unacceptable toxicity.

Formalin-fixed paraffin-embedded archived tumor tissue samples are assessed by IHC for
various biomarkers. Levels of Notch-1, Notch-4, cyclin A, cyclin B, Jagged-1, and DLL4 in
tumor-associated endothelial cells are correlated with response in both estrogen- and
progesterone-positive and negative tumors, and independently of p53 status.

After completion of study treatment, patients are followed for up to 2 years.

Inclusion Criteria


- Histologically or cytologically confirmed primary adenocarcinoma of the breast

- Locally recurrent or metastatic disease

- Must have HER-2-negative breast cancer or, if HER-2-positive, must be unable to
receive trastuzumab (Herceptin®) or have previously received trastuzumab in the past

- Measurable disease, defined as at least one lesion that can be accurately measured in
at least one dimension (longest diameter to be recorded) as > 20 mm by conventional
techniques or as > 10 mm by spiral CT scan.

- No known CNS disease

- Hormone receptor status not specified


Inclusion criteria:

- Postmenopausal status not specified

- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%

- Life expectancy > 12 weeks

- WBC ≥ 3,000/mcL

- Absolute neutrophil count ≥ 1,500/mcL

- Platelet count ≥ 100,000/mcL

- Total bilirubin normal

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

- Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastasis is present in the
absence of liver metastasis)

- Creatinine ≤ 1.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other concurrent malignancies within the past 5 years except basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

Exclusion criteria:

- Pre-existing neuropathy ≥ grade 1

- Uncontrolled intercurrent illness including, but not limited to, any of the

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Serious, non-healing wound, ulcer, or bone fracture

- Psychiatric illness/social situations that would limit compliance with study

- Inadequately controlled hypertension (defined as systolic blood pressure > 150 mm Hg
and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications)

- History of hypertensive crisis or hypertensive encephalopathy

- New York Heart Association class II-IV congestive heart failure

- History of myocardial infarction or unstable angina within the past 6 months

- History of stroke or transient ischemic attack within the past 6 months

- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)

- Symptomatic peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Significant traumatic injury within the past 28 days

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within the past 6 months

- Proteinuria, as demonstrated by either urine protein:creatinine ratio ≥ 1.0 OR urine
dipstick for proteinuria ≥ 2+

- Patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline
must demonstrate 24-hour urine protein ≤ 1g

- History of allergy or hypersensitivity to paclitaxel albumin-stabilized nanoparticle
formulation, paclitaxel, bevacizumab, carboplatin, albumin, drug product excipients,
or chemically similar agents


- See Disease Characteristics

- Recovered from all prior therapy

- No prior chemotherapy for locally recurrent or metastatic disease

- Prior neoadjuvant or adjuvant chemotherapy allowed

- More than 1 week since prior core biopsy or other minor surgical procedure, excluding
placement of a vascular access device

- More than 4 weeks since prior and no concurrent major surgical procedure or open

- More than 4 weeks since prior radiotherapy

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)

- At least 1 year since prior taxane regimen

- No other concurrent investigational agents

- Concurrent anticoagulation allowed, provided the following criteria are met:

- Stable dose of warfarin or low molecular weight heparin

- INR within desired range (2-3)

- No evidence of active bleeding or coagulopathy

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent radiotherapy, chemotherapy, immunotherapy, or antitumor hormonal

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

Treatment will continue until disease progression.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Shelly Lo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loyola University


United States: Food and Drug Administration

Study ID:




Start Date:

October 2007

Completion Date:

February 2013

Related Keywords:

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



Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
Swedish-American Regional Cancer Center Rockford, Illinois  61104-2315
Edward Hospital Cancer Center Naperville, Illinois  60540
Delnor Community Hospital - Geneva Geneva, Illinois  60134
Central Dupage Cancer Center Warrenville, Illinois  60555
Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital Downers Grove, Illinois  60515-1500