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

NCT00472693 | Completed Phase 2 DMC

• 1 other identifier: UPCC 02106
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Metastatic breast cancer; Second-Line Therapy; Triple Negative; Her-2 negative; Hormone receptor negative; Abraxane; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• 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.

  Study Completion

Secondary Outcomes (2)

• To determine the overall response rate to bevacizumab + ABI-007 in this study population.

  Study completion

• To determine the toxicity of bevacizumab + ABI-007 in this study population.

  Study completion

Study Arms (1)

Bevacizumab and ABI-007 (Abraxane)

EXPERIMENTAL

Bevacizumab and ABI-007 (Abraxane)

Drug: Bevacizumab, Abraxane

Interventions

Bevacizumab, Abraxane DRUG

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.

Bevacizumab and ABI-007 (Abraxane)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins

Study Officials

• Angela DeMichele, M.D.

  Abramson Cancer Center of University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2007
• First Posted: May 14, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 9, 2020

Record last verified: 2020-04

Locations

US (1)