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

NCT00434356 | Terminated Phase 2 Results

• 1 other identifier: AVF4057g
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Keywords

Avastin; MBC; Breast Cancer; Sutent

Outcome Measures

Primary Outcomes (1)

• Best Response

  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.

  From randomization until disease progression/recurrence (by patient)

Secondary Outcomes (5)

• Serious Adverse Events (SAEs)

  30 days following the last administration of study treatment

• Grade ≥ 3 Adverse Events (AEs)

  30 days following the last administration of study treatment

• Adverse Events Leading to Death

  30 days following the last administration of study treatment

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

  30 days following the last administration of study treatment

• Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption

  30 days following the last administration of study treatment

Study Arms (2)

1

EXPERIMENTAL

Drug: bevacizumab; Drug: sunitinib; Drug: paclitaxel

2

PLACEBO COMPARATOR

Drug: bevacizumab; Drug: paclitaxel

Interventions

bevacizumab DRUG

Intravenous repeating dose

1; 2

sunitinib DRUG

Oral repeating dose

1

paclitaxel DRUG

Intravenous repeating dose

1; 2

Eligibility Criteria

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

You may qualify if:

• Signed Informed Consent Form
• Histologically or cytologically confirmed adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease
• Age ≥ 18 years
• Adequate left ventricular function at study entry, defined as an Left Ventricular Ejection Fraction (LVEF) \> 50% by either Multi Gated Acquisition(MUGA) scan or Electrocardiogram (ECHO)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Ability and willingness to comply with study and follow-up procedures

You may not qualify if:

• Unknown HER2 status or known HER2-positive status
• Prior chemotherapy for locally recurrent or metastatic disease
• Prior hormonal therapy within 2 weeks prior to Day 1
• Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior to Day 1
• Prior adjuvant or neoadjuvant non-taxane chemotherapy within 6 months prior to Day 1
• For patients who have received recent radiotherapy, ongoing Grade ≥ 3 acute toxicity
• Patients with brain metastasis on full dose anticoagulation therapy
• Life expectancy of \< 12 weeks
• Current, recent (within 4 weeks of Day 1), or planned participation in an experimental drug study
• Inadequate organ function within 28 days prior to Day 1
• Untreated abnormal thyroid function tests
• Uncontrolled serious medical or psychiatric illness
• Active infection requiring IV antibiotics at enrollment or randomization
• History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
• Inadequately controlled hypertension

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Sunitinib; 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; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

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.

Results Point of Contact

• Title: Medical Communications Specialist
• Organization: Genentech, Inc.

800-821-8590

Study Officials

• Jai Balkissoon, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 9, 2007
• First Posted: February 13, 2007
• Study Start: March 1, 2007
• Primary Completion: May 1, 2008
• Last Updated: December 3, 2009
• Results First Posted: December 3, 2009

Record last verified: 2009-11