Bevacizumab Given With Either Anastrozole or Fulvestrant With Trastuzumab for Postmenopausal Metastatic Breast Cancer

NCT00405938 | Completed Phase 2 Results

• 1 other identifier: SCRI BRE 86
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 11

Brief Summary

This is a phase II trial combining bevacizumab with either fulvestrant or anastrozole with trastuzumab in the treatment of metastatic breast cancer in postmenopausal women. It is hoped that these combinations will keep the cancer from growing and spreading further.

Conditions

Breast Cancer; Breast Neoplasms

Keywords

Breast cancer; Metastatic breast cancer; Bevacizumab; Anastrozole; Fulvestrant

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

  Progression Free Survival (PFS) is defined as the interval, in months, from the date of first treatment to the date of disease progression or death, whichever occurred first.

  18 months

Secondary Outcomes (1)

• Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

  18 months

Study Arms (2)

Bevacizumab/anastrozole

EXPERIMENTAL

Bevacizumab 10mg/kg IV every 2 weeks \[patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)\] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.

Drug: Bevacizumab; Drug: Anastrozole

Bevacizumab/fulvestrant

EXPERIMENTAL

Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks \[patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)\] fulvestrant (500 mg IM on Day 1 of Cycle 1, followed by 250 mg IM of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg IM of fulvestrant). Treatment will be given in 4-week cycles.

Drug: Bevacizumab; Drug: Fulvestrant

Interventions

Bevacizumab DRUG

Bevacizumab 10mg/kg IV every 2 weeks

Also known as: Avastin

Bevacizumab/anastrozole; Bevacizumab/fulvestrant

Anastrozole DRUG

anastrozole (1 mg orally daily)

Also known as: Arimidex

Bevacizumab/anastrozole

Fulvestrant DRUG

fulvestrant (500 mg IM on Day 1 of Cycle 1, followed by 250 mg IM of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg IM of fulvestrant).

Also known as: Faslodex

Bevacizumab/fulvestrant

Eligibility Criteria

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

You may qualify if:

• Postmenopausal breast cancer (adenocarcinoma) estrogen (ER)and/or progesterone (PR) receptor positive that is locally advanced or locally recurrent and not able to be surgically removed OR with measurable and/or disease that is able to be assessed including isolated bone metastasis
• Female patients 18 years or older
• Documentation of ER+ and/or PR+
• No prior chemotherapy or hormone therapy for metastatic breast cancer or inoperable breast cancer that is locally recurrent or locally advanced
• Measurable or evaluable disease
• Radiation therapy to painful bone lesions or impending fractures is allowed as long as there is measurable or evaluable disease outside the radiated area.
• Must have adequate bone marrow, renal and liver function
• Patients receiving prior treatment with an anthracycline based chemotherapy must have a normal left ventricle ejection fraction

You may not qualify if:

• No metastatic disease to the Central Nervous System
• No history of myocardial infarction (MI), stroke or transient ischemic attacks in the last 6 months
• No symptoms of peripheral vascular disease
• No history of abdominal fistula, gastrointestinal perforation or intrabdominal abscess in the past 6 months
• No known hypersensitivity to phosphate, trehalose or polysorbate
• No serious non-healing wound, ulcer or bone fracture
• No uncontrolled high blood pressure or history of hypertensive crisis
• No New York Hear Association class II congestive heart failure
• No extensive cancer involvement of the liver or lungs
• No history of significant psychiatric disorders
• No significant vascular disease

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Genentech, Inc.: collaborator
• AstraZeneca: collaborator

Study Sites (11)

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Integrated Community Oncology Network

Jacksonville, Florida, 32256, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Wellstar Cancer Research

Marietta, Georgia, 30060, United States

Location

Graves-Gilbert Clinic

Bowling Green, Kentucky, 42101, United States

Location

Baton Rouge General Medical Center

Baton Rouge, Louisiana, 70806, United States

Location

St. Louis Cancer Care

Chesterfield, Missouri, 63017, United States

Location

Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Chattanooga Oncology & Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• Yardley DA, Burris HA 3rd, Clark BL, Shipley D, Rubin M, Barton J Jr, Arrowsmith E, Hainsworth JD. Hormonal therapy plus bevacizumab in postmenopausal patients who have hormone receptor-positive metastatic breast cancer: a phase II Trial of the Sarah Cannon Oncology Research Consortium. Clin Breast Cancer. 2011 Jun;11(3):146-52. doi: 10.1016/j.clbc.2011.03.010. Epub 2011 Apr 20.

  PMID: 21665134 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Anastrozole; Fulvestrant

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; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: John Hainsworth, MD
• Organization: Sarah Cannon Research Institute

asksarah@scresearch.net

1-877-691-7274

Study Officials

• Denise A Yardley, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

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: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 30, 2006
• Study Start: November 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2011
• Last Updated: November 18, 2021
• Results First Posted: February 15, 2013

Record last verified: 2021-11

Locations

US (11)