ABI-007 and Bevacizumab in Treating Women With Recurrent or Metastatic Breast Cancer

NCT00404404 | Unknown Phase 2

• 5 other identifiers: CDR0000515534PREMIERE-AVF3678sPREMIERE-20061500GENENTECH-PREMIERE-AVF3678sABRAXIS-PREMIERE-AVF3678s
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 stop the growth of tumor cells by blocking blood flow to the tumor. Giving ABI-007 together with bevacizumab may kill more tumor cells. PURPOSE: This phase II is studying how well giving ABI-007 together with bevacizumab works in treating women with recurrent or metastatic breast cancer.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival as measured by RECIST criteria at 1 and 2 years

Secondary Outcomes (5)

• Response rate measured every 3 courses during treatment

• Overall survival

• Time to progression

• Disease-free survival

• Toxicity

Interventions

bevacizumab BIOLOGICAL

paclitaxel albumin-stabilized nanoparticle formulation DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed invasive breast cancer * Recurrent or metastatic disease OR locally recurrent disease not amenable to resection with curative intent * Measurable or nonmeasurable disease * No CNS metastases by CT scan or MRI * No HER2-neu-positive tumors * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * Performance status 0-1 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count \> 100,000/mm³ * Creatinine \< 2.0 mg/dL * Bilirubin normal * AST ≤ 2 times upper limit of normal (ULN) (5 times ULN if there is known liver involvement) * Urine protein:creatinine ratio \< 1.0 OR proteinuria \< 2+ by urine dipstick OR ≤ 1 g protein on 24-hour urine collection * No peripheral neuropathy \> grade 1 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancies within the past 5 years except carcinoma in situ of the cervix, melanoma in situ, or basal cell carcinoma of the skin * No inadequately controlled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg and/or diastolic BP \> 100 mm Hg on antihypertensive medications * No prior hypertensive crisis or hypertensive encephalopathy * No New York Heart Association class II-IV congestive heart failure * No myocardial infarction or unstable angina within the past 6 months * No stroke or transient ischemic attack within the past 6 months * No significant vascular disease (e.g., aortic aneurysm or aortic dissection) * No symptomatic peripheral vascular disease * No evidence of bleeding diathesis or coagulopathy * No significant traumatic injury within the past 28 days * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * No serious, nonhealing wound, ulcer, or bone fracture * No known hypersensitivity to any component of bevacizumab PRIOR CONCURRENT THERAPY: * No prior paclitaxel albumin-stabilized nanoparticle formulation (ABI-007; Abraxane\^®) or bevacizumab * No prior chemotherapy for metastatic disease * Prior hormonal therapy for metastatic disease allowed * At least 4 weeks since any prior therapy for cancer * More than 12 months since prior adjuvant chemotherapy, including use of a taxane * More than 28 days since prior major surgery or open biopsy * More than 7 days since prior core biopsy or minor surgery (excluding placement of a vascular access device) * No concurrent major surgery * No other concurrent therapy for breast cancer * Concurrent bisphosphonates allowed if there is bone involvement * No concurrent prophylactic granulocyte colony-stimulating factors

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Premiere Oncology: lead

Study Sites (1)

Premiere Oncology

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Taxes

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; Economics; Health Care Economics and Organizations

Study Officials

• Linnea Chap, MD

  Premiere Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 27, 2006
• First Posted: November 28, 2006
• Study Start: October 1, 2006
• Last Updated: December 18, 2013

Record last verified: 2007-04

Locations

US (1)