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A Multicenter, Phase III, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Untreated Metastatic Breast Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Metastatic Breast Cancer

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Trial Information

A Multicenter, Phase III, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Untreated Metastatic Breast Cancer


Inclusion Criteria:



- Histologically or cytologically confirmed adenocarcinoma of the breast, with
measurable or non-measurable locally recurrent or metastatic disease

- Signed Informed Consent Form

- Age >/= 18 years

- For women of childbearing potential, use of accepted and effective method of
non-hormonal contraception

- ECOG performance status of 0 or 1

- Ability and capacity to comply with study and follow-up procedures

- For anthracycline cohort only: adequate left ventricular function at study entry,
defined as an LVEF >/= 50% by either MUGA scan or ECHO.

- For subjects who have received recent radiation therapy: recovery prior to Day 0 from
any significant (Grade >/= 3) acute toxicity

Exclusion Criteria:

- Unknown HER2 status or known HER2-positive status

- Prior chemotherapy for locally recurrent or metastatic disease

- Prior hormonal therapy less than 1 week prior to Day 0

- Prior adjuvant or neoadjuvant chemotherapy within 12 months prior to Day 0

- For anthracycline cohort only: Prior anthracycline as part of neoadjuvant or adjuvant
therapy for localized breast cancer

- Investigational therapy within 28 days of Day 0

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, or anticipation of need for major surgical procedure during the
course of the study

- Minor surgical procedures, such as fine needle aspirations or core biopsies, within 7
days prior to Day 0

- Prior therapy with bevacizumab, sorafenib, sunitinib, or other VEGF pathway-targeted
therapy

- Known brain or other CNS metastases

- Blood pressure of > 150/100 mm Hg

- Unstable angina

- New York Heart Association (NYHA) Grade II or greater CHF

- History of myocardial infarction within 6 months prior to Day 0

- History of stroke or transient ischemic attack within 6 months prior to Day 0

- Clinically significant peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to Day 0

- Serious non-healing wound, ulcer, or bone fracture

- Pregnancy (positive serum pregnancy test) or lactation

- Inadequate organ function, as evidenced by any of the following laboratory values:
Absolute neutrophil count < 1500/uL; Platelet count < 100,000/uL; Total bilirubin >
1.5 mg/dL; Alkaline phosphatase, AST, and/or ALT > 2x upper limit of normal (> 5x ULN
in subjects with known liver or, for alkaline phosphatase elevations, bone
involvement); Alkaline phosphatase > 2x ULN (> 7x ULN in subjects with known bone
involvement); Serum creatinine > 2.0 mg/dL; PTT and/or either INR or PT > 1.5x upper
limit of normal (except for subjects receiving anti-coagulation therapy); Urine
protein/creatinine ratio > 1.0 at screening for U.S. subjects, or urine dipstick for
proteinuria >/= 1+ at screening followed by 24-hour urine collection demonstrating >
1 g protein/24 hr for ex-U.S. subjects

- Uncontrolled serious medical or psychiatric illness

- Active infection requiring intravenous (IV) antibiotics at Day 0

- History of other malignancies within 5 years of Day 0 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
(subjects with a history of bilateral breast cancer will be eligible)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Length of study

Safety Issue:

No

Principal Investigator

Leonardo Faoro, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

AVF3694g

NCT ID:

NCT00262067

Start Date:

June 2006

Completion Date:

December 2013

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

Name

Location

Bettendorf, Iowa  52722
Fountain Valley, California  92708
Kansas City, Kansas  66160