Study of Avastin (Bevacizumab) to Reverse Acquired Estrogen Independence in Previously Hormone Responsive Metastatic Breast Ca.

NCT00240071 | Completed Phase 2 Results DMC

• 2 other identifiers: F050103001UAB 0461
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if acquired hormone therapy resistance can be reversed by Avastin (Bevacizumab), as measured by time to disease progression and evaluate toxicity of the combination of hormone treatment plus Avastin (Bevacizumab).

Conditions

Metastatic Breast Cancer

Keywords

Breast cancer; Metastatic breast cancer; Hormonal therapy; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression free survival is defined as time from date of registration until the date of first documented disease progression or date of death from any cause, whichever occurs first.

  From date of registration until disease progression or death, whichever occurs first

Secondary Outcomes (1)

• Objective Response Rate (Defined as the Rate of Complete and Partial Responses).

  From date of registration until disease progression or death, whichever occurs first

Study Arms (1)

Avastin

EXPERIMENTAL

The patient will continue the same hormonal therapy used prior to study enrollment but will combine it with Avastin.

Drug: Avastin; Drug: Hormonal therapy

Interventions

Avastin DRUG

All patients will received Avastin 15 mg/kg IV every three weeks. The first evaluation will be done at Week 6. Patients with objective response or stable disease will continue therapy with restaging every 6 weeks until evidence of disease progression. Patients with progression of disease will be taken off study.

Also known as: Bevacizumab

Avastin

Hormonal therapy DRUG

aromatase inhibitor (letrozole 2.5mg/d PO, anastrazole 1mg/d PO, or exemestane 25mg/d PO)or Selective Estrogen Receptor Modulator (SERM) (tamoxifen 20mg/d PO)

Also known as: Femara (letrozole), Arimidex (anastrazole), Aromasin (exemestane), Nolvadex (tamoxifen)

Avastin

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have cytologically or histologically proven breast cancer which is estrogen receptor or progesterone receptor positive and is locally advanced and /or metastatic.
• Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice (Appendix E).
• Be female and greater than or equal to 19 years of age (age limit required by the State of Alabama). Women of childbearing potential must have a negative pregnancy test and must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Be ambulatory (outpatient) and have an Eastern Cooperative Oncology Group (ECOG) PS \<2 (Appendix B).
• Previous treatment: Patients must have responded to first or second line hormonal therapy (Partial and complete response greater than 6 months using RECIST criteria. Patients with stable disease for more than 6 months will be eligible) and became resistant to the hormonal agent. They must remain on the current hormone therapy to which they initially responded but now are resistant.
• Clear documentation of acquired hormonal resistance.
• Evaluable disease will be considered eligible, but measurable disease according to RECIST criteria will be preferable (Appendix C). The target lesion(s) must not have been previously irradiated (newly arising lesions in previously irradiated areas are acceptable).
• Patients must have adequate organ and marrow function as defined as follows: absolute neutrophil count \> 1,500/mm3, hemoglobin \> 8.0 g/dl, platelets \> 75,000/mm3, total bilirubin \< 2 mg/dl, serum creatinine \< 2 mg/dl, transaminases (AST, ALT) may be up to 2.5 x institutional upper limit of normal for patients with no liver metastases and up to 5 x institutional upper normal limit for patients with documented liver metastases. In addition \< 1 gr of protein in 24 hr urine collection and urine protein/creatinine ratio \< 1.0
• Prior chemotherapy does not exclude patients from study as long as the current therapy was hormonal therapy alone.
• Patients with de novo hormone therapy resistance will not be eligible.
• No life threatening parenchymal disease or rapidly progressing disease warranting cytotoxic chemotherapy.
• No history of brain metastases.
• No history of thrombosis during the previous year, including transient ischemic attack.
• Hypertension must be controlled (\< 150/100 mmHg).
• Ejection Fraction \> 50%.

You may not qualify if:

• Patients who are "de novo" resistant to hormone therapy.
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than this Genentech-sponsored bevacizumab cancer study.
• Blood pressure of \>150/100 mmHg
• Unstable angina
• New York Heart Association (NYHA) Grade II or greater congestive heart failure
• History of myocardial infarction within 6 months
• History of stroke within 6 months
• Clinically significant peripheral vascular disease
• History of a bleeding disorder
• Presence of central nervous system or brain metastases
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
• Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
• Pregnant (positive pregnancy test) or lactating
• Urine protein: creatinine ratio greater than or equal to 1.0 at screening. Patients demonstrating \> 1 gr of protein in 24 hr urine collection within 4 weeks prior to study entry will not participate in the trial.
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Letrozole; Anastrozole; exemestane; Tamoxifen

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; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

A Phase II trial.

Results Point of Contact

• Title: Carla I Falkson
• Organization: University of Alabama at Birmingham

cfalkson@uab.edu

205-975-2691

Study Officials

• Carla Falkson, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 13, 2005
• First Posted: October 17, 2005
• Study Start: October 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2011
• Last Updated: October 30, 2019
• Results First Posted: September 27, 2011

Record last verified: 2019-10

Locations

US (1)