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A Phase II Trial of Open-Label Bevacizumab Administered With Anastrozole or Fulvestrant as First-Line Therapy in Postmenopausal Hormone Receptor- Positive Metastatic Breast Cancer (With Trastuzumab in HER2-Positive Patients)


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Breast Neoplasms

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Trial Information

A Phase II Trial of Open-Label Bevacizumab Administered With Anastrozole or Fulvestrant as First-Line Therapy in Postmenopausal Hormone Receptor- Positive Metastatic Breast Cancer (With Trastuzumab in HER2-Positive Patients)


Regimen A: Bevacizumab/anastrozole (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)] and anastrozole (1 mg orally daily). Treatment will be given in
4-week cycles. Response assessments will be performed after 2 cycles. Patients who respond
to treatment or have stable disease will continue to be evaluated every 2 cycles. After 6
months, response assessment will occur every 3 months. A patient may remain on study if
radiation is deemed necessary and appropriate, provided that there are other sites of
measurable disease outside the field of radiation that may be followed. Treatment occurs
until disease progression. Patients will be selected for this treatment arm per the
following guidelines: >=12 months from adjuvant endocrine therapy OR >=12 months from
adjuvant aromatase inhibitors OR Endocrine therapy naive OR Prior tamoxifen exposure or
tamoxifen intolerance

Regimen B: 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 intramuscular on Day 1 of Cycle 1, followed
by 250 mg intramuscular 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 intramuscularly of fulvestrant). Treatment will be given in 4-week cycles. Response
assessments will be performed after 2 cycles. Patients who respond to treatment or have
stable disease will continue to be evaluated every 2 cycles. After 6 months, response
assessment will occur every 3 months. A patient may remain on study if radiation is deemed
necessary and appropriate, provided that there are other sites of measurable disease outside
the field of radiation that may be followed. Treatment occurs until disease progression.
Patients will be selected for this treatment arm per the following guidelines: <12 months
from adjuvant aromatase inhibitor therapy OR Intolerant of aromatase inhibitors OR Disease
progression on adjuvant aromatase inhibitors OR Physician discretion

Trastuzumab: Patients in Treatment Arm A or Treatment Arm B who have FISH HER2+ or IHC3+
breast cancer will also receive treatment with trastuzumab in addition to their treatment
with the combination of bevacizumab with either anastrozole or fulvestrant. Trastuzumab will
be administered ONLY to patients with HER2+ breast cancer (FISH-positive or IHC3+). An 8
mg/kg loading dose of IV trastuzumab will be administered on Day 1, followed by doses of 6
mg/kg IV trastuzumab once every 3 weeks. These patients will have the option of receiving
their bevacizumab doses at 15 mg/kg every 3 weeks rather than 10 mg/kg every 2 weeks (if
they prefer to keep their bevacizumab dosing schedule consistent with their trastuzumab
dosing schedule so that the number of visits they must make to the study site is minimized).
The dosing schedules for anastrozole (for HER2+ patients in Treatment Arm A) and fulvestrant
(for HER2+ patients in Treatment Arm B) will not change.


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

There are additional inclusion/exclusion criteria. The study center will determine if you
meet all of the criteria. If you do not qualify for the trial, study personnel will
explain the reasons. If you do qualify, study personnel will explain the trial in detail
and answer any questions you may have. You can then decide if you wish to participate.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

Defined as the interval, in months, from the date of first treatment to the date of disease progression or death, whichever occurred first.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Denise A Yardley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI BRE 86

NCT ID:

NCT00405938

Start Date:

November 2006

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms
  • Breast cancer
  • Metastatic breast cancer
  • Bevacizumab
  • Anastrozole
  • Fulvestrant
  • Breast Neoplasms
  • Neoplasms

Name

Location

Florida Hospital Cancer InstituteOrlando, Florida  32804
Florida Cancer SpecialistsFort Myers, Florida  33901
Northeast Georgia Medical CenterGainesville, Georgia  30501
Baton Rouge General Medical CenterBaton Rouge, Louisiana  70821-2511
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
St. Louis Cancer CareChesterfield, Missouri  63017
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Wellstar Cancer ResearchMarietta, Georgia  30060
Graves-Gilbert ClinicBowling Green, Kentucky  42101
Sletten Cancer InstituteGreat Falls, Montana  59405
Chattanooga Oncology & Hematology AssociatesChattanooga, Tennessee  37404