Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Bevacizumab

Sunitinib

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

bevacizumab

sunitinib

paclitaxel

Jai Balkissoon, M.D.

This is a multicenter, Phase II, randomized, controlled, open label trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with bevacizumab and paclitaxel in patients who have not previously received chemotherapy for locally recurrent or metastatic breast cancer.

A Study of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer (SABRE-B)

A Multicenter, Phase II, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer

The best overall response is the best response, per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.

All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator

All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. Grading: 1=Mild AE; 2=Moderate AE; 3=Severe AE; 4=Life-threatening or disabling AE; 5=Death related to AE

All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0

Genentech, Inc.

Jai Balkissoon, M.D., Study Director

Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest

Bevacizumab + Paclitaxel + Sunitinib

Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest

Bevacizumab + Paclitaxel

Total

< 18 Years

Between 18 and 40 Years

Between 41 and 64 Years

>= 65 Years

Age, Customized

Age Continuous

Sex: Female, Male

Based on the early safety results from this study, further recruitment and treatment was halted. Insufficient efficacy data were available to perform all protocol-specified analyses and limited the interpretation of the analyses performed.

Medical Communications Specialist

Complete Response

Partial Response

Stable Disease

Progressive Disease

Unable to Evaluate

Missing

Randomized patients with at least one scan available at baseline and post-baseline

Best Response

Febrile Neutropenia

Haemolytic Anaemia

Neutropenia

Constipation

Diarrhoea

Gastrointestinal Perforation

Haemorrhoids

Vomiting

Chest Pain

Asthenia

Anaphylactic Reaction

Drug Hypersensitivity

Upper Respiratory Tract Infection

Cellulitis

Pneumonia

Tooth Infection

Spinal Compression Fracture

Dehydration

Hypoglycaemi

Syncope

Pulmonary Embolism

Epistaxis

Hypoxia

Skin Ulcer

Serious Adverse Events (SAEs)

Leukopenia

Lymphopenia

Nausea

Small Intestinal Obstruction

Fatigue

Mucosal Inflammation

Hyperbilirubinaemia

Otitis Media

Urinary Tract Infection

Thermal Burn

Haemoglobin Decreased

Neutrophil Count Decreased

Anorexia

Hypoglycaemia

Neuropathy Peripheral

Headache

Migraine

Haematuria

Palmar-Plantar Erythrodysaesthesia Syndrome

Hypertension

Grade ≥ 3 Adverse Events (AEs)

Adverse Events Leading to Death

Thrombocytopenia

Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction

Spots Global Cancer Trial Database for A Study of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer (SABRE-B)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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