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ABI-007 In Combination With Bevacizumab in Women With Metastatic Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

ABI-007 In Combination With Bevacizumab in Women With Metastatic Breast Cancer

A Phase II Trial of Weekly Administration of ABI-007 In Combination With Bevacizumab in Women With Metastatic Breast Cancer

NCT00394082•Celgene

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and tolerability of weekly ABI-007 in combination with bevacizumab. The evaluation of progression-free survival of weekly ABI-007 in combination with bevacizumab for patients with previously untreated advanced/metastatic breast cancer.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Pathologically confirmed adenocarcinoma of the breast.
•Stage IV disease.
•Measurable disease (defined as the presence of at least one lesion that can be accurately measured in at least one dimension with longest diameter greater or = 1.0 cm with spiral computed tomography (CT) scan).
•Patients must not be a candidate for Herceptin therapy (i.e., patients with HER-2 positive disease (gene amplification by fluorescence in situ hybridization (FISH) or 3 + overexpression by ICH) and patients with unknown HER-2 status are ineligible unless the treating physicians has determined that Herceptin-based therapy would be inappropriate or not indicated).
•For subjects with prior anthracycline exposure, normal cardiac function including a baseline left ventricle ejection fraction \>50% or above institution's lower limit of normal and a normal electrocardiogram (ECG) (as assessed by the investigator).
•At least 2 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease within the radiation portal.
•International Normalized Ratio (INR) \< 1.5 and activated partial thromboplastin time within normal limits (APTT WNL).
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
•Female \> 18 years of age.
•Patients have the following blood counts at Baseline: absolute neutrophil count (ANC) greater or equal to 1.5 x 10\^9 cells/L; platelets greater or equal 100 x 10\^9 cells/L; hemoglobin (Hgb) greater or equal to 9g/dL.
+4 more criteria

Exclusion Criteria

•No prior chemotherapy for metastatic or locally recurrent disease is allowed.
•Prio neo-adjuvant chemotherapy is allowed, and patients must have recovered from the acute toxicity of such therapies.
•* if a taxane was part of the adjuvant regimen, at least 12 months must have elapsed between the last dose of the taxane and the date of diagnosis of metastatic disease.
•* if a non-taxane-based adjuvant therapy was administered, at least six months must have elapsed between the last dose of the non- taxane-containing chemotherapy and the date of diagnosis of metastatic disease.
•Concurrent immunotherapy or hormonal therapy.
•Parenchymal brain metastases, including leptomeningeal involvement.
•Uncontrolled hypertension (defined as blood pressure of \> 150/100 mmHg)
•NYHA Grade 2 or greater congestive heart failure
•History of coagulopathy, bleeding diathesis, therapeutic anticoagulation other than low dose or chronic ASA greater than or equal to 325 mg per day. Low dose coumadin for anticoagulation of venous access device or low dose molecular weight heparin (LMWH)for deep vein thrombosis prophylaxis or low dose (325 mg or less) ASA prophylaxis are allowed, but are best avoided if the treating physician feels it is safe to do so.
•Urine protein:creatinine ratio less than or equal to 1.0 at screening.
+10 more criteria

Locations (20)

Melbourne, Florida, United States

Ocoee, Florida, United States

Niles, Illinois, United States

Terre Haute, Indiana, United States

Columbia, Maryland, United States

Westminister, Maryland, United States

Saint Joseph, Missouri, United States

Rochester, New York, United States

Bedford, Texas, United States

Dallas, Texas, United States

Key Dates

Start Date

June 1, 2006

Primary Completion Date

September 1, 2009

Completion Date

February 1, 2011

Last Updated

November 25, 2019

Enrollment

ACTUAL participants

Conditions

Metastatic Breast Cancer

Interventions

ABI-007

DRUG

Bevacizumab

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ABI-007 In Combination With Bevacizumab in Women With Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

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