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A Randomized Phase III Double-Blind Placebo-Controlled Trial of First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab for Patients With HER-2/NEU Over-Expressing Metastatic Breast Cancer

Phase 3
18 Years
Open (Enrolling)
HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

Thank you

Trial Information

A Randomized Phase III Double-Blind Placebo-Controlled Trial of First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab for Patients With HER-2/NEU Over-Expressing Metastatic Breast Cancer


I. Evaluate efficacy of the addition of bevacizumab in patients eligible for first-line
trastuzumab with chemotherapy for HER-2/NEU overexpressing metastatic breast cancer, by
assessing the progression-free survival (PFS) after initiation of combination therapy.


I. Evaluate response rates (RR) in patients with measurable disease (RECIST), when

II. Evaluate overall survival (OS). III. Evaluate time to progression (TTP). IV. Evaluate
the percent of patients who are progression-free (PPF) at 6 months.

V. Compare the toxicity of chemotherapy/trastuzumab to that of chemotherapy/ trastuzumab in
combination with bevacizumab.

VI. Compare breast cancer symptoms and treatment related symptoms between patients receiving
chemotherapy and trastuzumab with or without bevacizumab.

VII. Evaluate whether PFS correlates with VEGF levels in breast tumor tissue. VIII. Analysis
of Circulating Tumor Cells and Circulating Endothelial Cells (CEC).

IX. Serially enumerate CTC and CEC in patients on study and determine whether: The number of
CTC and CEC decrease in responding patients; the extent of CTC and CEC decrease is greater
in the experimental arm, Arm B versus the control arm, Arm A; enumeration of CTC and CEC in
responding patients correlate with progression free survival (PFS).

X. Perform an exploratory analysis of phosphorylation status of akt-2 in circulating tumor

XI. Perform an exploratory analysis of RT-PCR of CTC mRNA to determine whether change in
expression of selected down stream targets of bevacizumab therapy can serve as
pharmacodynamic or surrogate markers of bevacizumab targeting and modulation.

OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment
with adjuvant trastuzumab (Herceptin) (yes vs no), prior treatment with neoadjuvant or
adjuvant taxane (yes vs no), disease-free interval (> 24 months vs =< 24 months), and
planned treatment with carboplatin (yes vs no). Patients are randomized to 1 of 2 treatment


INDUCTION THERAPY: Patients receive trastuzumab intravenously (IV) over 30-90 minutes on
days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over
60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day
1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease
progression or unacceptable toxicity.

MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients
receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1.
Treatment repeats every 3 weeks in the absence of disease progression or unacceptable


INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin
as in arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15.
Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or
unacceptable toxicity.

MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients
receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1.
Treatment repeats every 3 weeks in the absence of disease progression or unacceptable

After completion of study treatment, patients are followed periodically for 10 years.

Inclusion Criteria:

- ECOG performance status of 0 or 1

- Histologically confirmed breast cancer that overexpresses HER-2/NEU

- HER-2/NEU overexpression is defined as 3+ HER-2 positivity as measured by
immunohistochemistry OR HER-2 gene amplification as measured by FISH

- Evidence of metastatic disease and/or chest wall recurrence

- Evaluable (measurable or non-measurable) disease is allowed if confirmed within 4
weeks prior to study randomization

- No history or radiologic evidence of CNS disease

- Platelet count >= 100,000/mm^3

- Total bilirubin =< 1.5 mg/dL

- AST =< 2 times upper limit of normal (ULN) (=< 5 times normal in patients with known
liver involvement)

- Serum creatinine =< 1.5 mg/dL

- Urine protein:creatinine ratio =< 0.5 OR 24-hour urine protein < 1,000 mg

- INR =< 1.5 times ULN

- PTT =< 1.5 times ULN

- LVEF above the lower limit of normal by MUGA scan or ECHO

- No grade 2-4 neuropathy

- No unstable angina pectoris

- No serious cardiac arrhythmia requiring medication

- No clinically significant peripheral vascular disease

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No current non-healing wound or fracture

- No hypersensitivity to Chinese hamster ovary cell products or other recombinant human
antibodies, paclitaxel, or drugs using the vehicle Cremophor

- No serious medical or psychiatric illness that would preclude study participation

- No other active malignancy within the past 5 years except carcinoma in situ of the
cervix or nonmelanoma skin cancer

- Adjuvant or neoadjuvant taxane therapy for breast cancer is allowed provided last
dose was given >= 12 months prior to diagnosis of recurrence

- No prior chemotherapy, trastuzumab, or bevacizumab for metastatic breast cancer

- No prior cumulative dose of doxorubicin hydrochloride > 360 mg/m2 or epirubicin
hydrochloride > 640 mg/m2 (in the neoadjuvant or adjuvant setting)

- More than 4 weeks since prior major surgical procedure (except for non-operative

- More than 7 days since prior placement of a vascular access device

- Concurrent full-dose anticoagulants (e.g., warfarin) with PT/INR > 1.5 allowed
provided the following criteria are met:

- In-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a
stable dose of low molecular weight heparin

- No active bleeding or pathological condition that carries a high risk of bleeding
(e.g., tumor involving major vessels or known varices)

- No concurrent local radiotherapy for pain control or life-threatening situations

- No concurrent drugs known to inhibit platelet function, including the following:

- dipyridamole,

- ticlopidine,

- clopidogrel,

- cilostazol

- Adjuvant trastuzumab (Herceptin) therapy for breast cancer is allowed provided last
dose was given >= 12 months prior to diagnosis of recurrence

- Adjuvant or neoadjuvant therapy with lapatinib ditosylate is allowed provided last
dose was given >= 4 weeks prior to diagnosis of recurrence

- Absolute neutrophil count >= 1,000/mm^3

- No clinically significant cardiovascular disease

- No cerebrovascular accident within the past 6 months

- No myocardial infarction or unstable angina within the past 6 months

- No New York Heart Association class II-IV congestive heart failure

- No uncontrolled hypertension

- Endocrine treatment in the adjuvant or metastatic setting is allowed, provided last
dose given >= 2 weeks prior to randomization

- More than 3 weeks since prior radiotherapy

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Description:

This primary comparison will be performed using a one-sided log rank test stratified using an overall type I error of 2.5%.

Outcome Time Frame:

From randomization to progression per RECIST, new second breast cancer primaries or to death from any cause without documentation of progression, whichever occurs first, assessed up to 10 years

Safety Issue:


Principal Investigator

Ingrid Mayer

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

November 2007

Completion Date:

Related Keywords:

  • HER2-positive Breast Cancer
  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms
  • Breast Neoplasms, Male



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Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
IU Health ArnettLafayette, Indiana  
Carle Foundation - Carle Cancer CenterUrbana, Illinois  61801
Emory University Hospital MidtownAtlanta, Georgia  30308
Eastern Cooperative Oncology GroupBoston, Massachusetts  02215
The Toledo Hospital/Toledo Children's HospitalToledo, Ohio  43606
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Essentia Health Duluth Clinic CCOPDuluth, Minnesota  55805
Essentia Health Saint Mary's Medical CenterDuluth, Minnesota  55805
Sanford Bismarck Medical CenterBismarck, North Dakota  58501
Toledo Clinic Cancer Centers-OregonOregon, Ohio  43616
Community Howard Regional HealthKokomo, Indiana  46904
Indiana University Health La Porte HospitalLa Porte, Indiana  46350
Saint Joseph Regional Medical Center-MishawakaMishawaka, Indiana  46545-1470
PeaceHealth Saint Joseph Medical CenterBellingham, Washington  98225
Illinois Cancer Specialists-NilesNiles, Illinois  60714
Springfield Regional Medical CenterSpringfield, Ohio  45505
NEA Baptist Memorial HospitalJonesboro, Arkansas  72401
Edward Hospital/Cancer CenterNaperville, Illinois  60540
Toledo Clinic Cancer Centers-Bowling GreenBowling Green, Ohio  43402
Toledo Clinic Cancer Centers-MaumeeMaumee, Ohio  43537-1839
Toledo Clinic Cancer Centers-ToledoToledo, Ohio  43623
PeaceHealth Southwest Medical CenterVancouver, Washington  98664