Bevacizumab and Abraxane as Second-line Therapy in Triple Negative Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00472693
First received: May 11, 2007
Last updated: January 31, 2013
Last verified: January 2012
  Purpose

The purpose of this study is to determine whether the addition of bevacizumab to Abraxane as second-line therapy in Her-2 negative, hormone receptor negative metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: Bevacizumab, Abraxane
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Bevacizumab and ABI-007 (Abraxane) as Second-line Therapy in Her-2 Negative, Hormone Receptor Negative Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • To determine progression-free survival among women receiving bevacizumab + ABI-007 given as second-line combination therapy for hormone receptive negative, Her-2 negative metastatic breast cancer. [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the overall response rate to bevacizumab + ABI-007 in this study population. [ Time Frame: Study completion ] [ Designated as safety issue: Yes ]
  • To determine the toxicity of bevacizumab + ABI-007 in this study population. [ Time Frame: Study completion ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: May 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab and ABI-007 (Abraxane)
Bevacizumab and ABI-007 (Abraxane)
Drug: Bevacizumab, Abraxane
Bevacizumab, 10 mg/m2 IV days 1 and 15; ABI-007, 100 mg/m2 IV days 1, 8, 15 of each 28 day cycle. Continue treatment until disease progression, patient withdrawal or unacceptable toxicities.

  Eligibility

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

Inclusion Criteria:

  • Female, aged 18 years or older and able to give informed consent.
  • Histologically- or cytologically-proven adenocarcinoma of the breast at time of first diagnosis
  • ECOG performance status 0 or 1
  • Life expectancy > 12 weeks
  • Stage IV disease and have at least one lesion measurable by standard RECIST criteria
  • Disease progression after at least one prior chemotherapy regimen for metastatic disease or within 12 months of adjuvant chemotherapy initiation.
  • All chemotherapy must be stopped > 2 weeks before enrollment.
  • Primary or metastatic tumor must be negative for estrogen and progesterone receptor expression. Testing must be done in a CLIA-approved laboratory.
  • Primary or metastatic tumor must have 0 or 1+ staining for HER2/neu identified immunohistochemically (IHC), by an approved method using one of the standard monoclonal or polyclonal antibodies (HercepTest, cb-11, PAb1, or TAB250), or if FISH status is known, it must be negative. Testing must be done in a CLIA-approved laboratory.
  • Left ventricular ejection fraction must be >= institutional lower limit of normal as determined by MUGA or echocardiogram
  • Patient must be able to comply with treatment and follow-up procedures:
  • Adequate bone marrow, liver and renal function; Absolute neutrophil count >= 1500/mm3; Hemoglobin >= 10 g/dl; Platelet count >= 100,000/mm3; Creatinine <= 2.0; PTT and either INR or PT < 1.5x normal; Total bilirubin <= 1.5 X upper limit of normal; AST, ALT, and alkaline phosphatase <= 2 X upper limit of normal (or <= 5X upper limit of normal if known liver metastases)
  • If female is of childbearing potential, pregnancy test must be negative and patient must be willing to use effective contraception while on treatment and for at least 3 months after the last dose of study medication

Exclusion Criteria:

  • Prior treatment with VEGF targeted therapy
  • Prior taxane therapy for metastatic disease or for adjuvant therapy within the previous 12 months
  • History of prior cancer, excluding carcinoma in situ of the cervix and non-melanoma skin cancers
  • Known CNS disease
  • Inadequately controlled hypertension (defined as systolic blood pressure>150 and/or diastolic blood pressure>100 mmHg on antihypertensive medications)
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 6 months prior to study enrollment
  • History of stroke or transient ischemic attack within 6 months prior to study enrollment
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
  • Symptomatic peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
  • Serious, non-healing wound, ulcer or bone fracture
  • Proteinuria at screening as demonstrated by either: Urine protein:creatinine (UPC) ratio >1.0 at screening OR Urine dipstick for proteinuria >2+ (patients discovered to have >2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate <1g of protein in 24 hours to be eligible)
  • Patients with active infection
  • Women who are pregnant or lactating
  • Radiation therapy within 3 weeks of study entry
  • Patients with hypersensitivity to ABI-007, Chinese hamster ovary cell products, or other recombinant human antibodies
  • Baseline neuropathy > grade 2
  • Participation in an investigational study of an antineoplastic agent within 4 weeks of first infusion of this study.
  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: NCT00472693

Locations
United States, Pennsylvania
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Genentech
Investigators
Principal Investigator: Angela DeMichele, M.D. Abramson Cancer Center of University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00472693     History of Changes
Other Study ID Numbers: UPCC 02106
Study First Received: May 11, 2007
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Breast cancer
Metastatic breast cancer
Second-Line Therapy
Triple Negative
Her-2 negative
Hormone receptor negative
Abraxane
Bevacizumab

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Bevacizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014