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A Randomized Phase III Study to Determine the Efficacy of a Taxane and Bevacizumab With or Without Capecitabine as First Line Chemotherapy in Patients With Metastatic Breast Cancer

Phase 3
18 Years
Not Enrolling
Breast Cancer

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Trial Information

A Randomized Phase III Study to Determine the Efficacy of a Taxane and Bevacizumab With or Without Capecitabine as First Line Chemotherapy in Patients With Metastatic Breast Cancer

Primary Objective:

- To determine the Progression Free Survival (PFS) in patients with metastatic breast
cancer after treatment with taxane plus bevacizumab with (TXB) or without capecitabine (TB).

Secondary Objective(s):

- To determine the objective response rate in both arms.

- To determine the duration of response in both arms.

- To determine the Time to Progression (TTP) in both arms.

- To determine the clinical benefit defined as CR, PR, or stable disease ≥ 24 weeks in
both arms.

- To determine the overall survival rate 3 years after "Last Patient In".

- To determine PFS and TTP response rates in patient's ≥ age 65.

- To determine the toxicity and compliance in both arms.

- To determine the predictive value of serum markers such as VEGF.

Inclusion Criteria:

- ECOG performance status 0-2

- Histological confirmed carcinoma of the breast with no over expression of HER2

- Locally advanced or metastatic stage of disease not suitable for surgery or
radiotherapy alone

- Patients must have either measurable or non-measurable target lesions according to
RECIST criteria (phase III). Complete staging work-up within 4 weeks prior to
registration. All patients must have chest X-ray (PA and lateral), abdominal
ultrasound or CT scan or MRI, and bone scan. In case of positive bone scan, bone
X-ray is mandatory. Other tests may be per- formed as clinically indicated

- The following previous systemic treatment are eligible:

- (neo)adjuvant chemotherapy (except if capecitabine was included) However if
(neo)adjuvant chemotherapy was anthracycline based, the maximum cumulative dose of
prior anthracycline therapy must not exceed 360 mg/m2 for doxorubicin and 720 mg/m2
for epirubicin. If taxanes or capecitabine were part of (neo)adjuvant treatment, a
treatment-free interval of > 6 months is requested

- adjuvant endocrine therapy.

- palliative endocrine treatments

- treatment with bisphosphonates

- treatment with immunotherapies

- Patient has to be fully recovered from previous radiotherapy. At least one measurable
lesion must be completely outside the radiation field or there must be pathologic
proof of progressive disease

- Absolute neutrophil count ≥ 2000 cells/ul, platelet count ≥ 100,000 cells/ul.

- Bilirubin ≤ 1.5x the upper limit of normal for the institution (ULN); elevation of
transaminases and alkaline phosphatase <2.5x ULN or <5x ULN for patients with liver

- Creatinine ≤ 1,25x ULN or creatinin-clearance > 50 ml/min (according to Cockroft
Gault). Urine dipstick for proteinuria <2+. Patients discovered to have ≥2+
proteinuria on dipstick urinalysis should undergo a 24 hour urine collection and must
demonstrate ≤1 g of protein in 24 hours

- Negative pregnancy test (urine or serum) within 14 days prior to registration for all
women of childbearing potential

- Patients must be available and compliant for treatment and follow-up. Patients
registered on this trial must be treated and followed up at the participating or a
cooperating site

Exclusion Criteria:

- Known hypersensitivity reaction to the compounds or incorporated substances or known
dihydropyrimidine dehydrogenase deficiency

- Previous chemotherapy for metastatic disease, concurrent immunotherapy or hormonal
therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may
be continued

- Life expectancy of less than 3 months

- Serious intercurrent medical or psychiatric illness that may interfere with the
planned treatment (including AIDS and serious active infection).

- Known or suspected congestive heart failure (>NYHA I) and/or coronary heart disease,
angina pectoris requiring antianginal medication, previous history of myocardial
infarction, evidence of transmural infarction on ECG, un- or poorly controlled
arterial hypertension (i.e. BP >150/100 mmHg under treatment with two
antihypertensive drugs), rhythm abnormalities requiring permanent treatment,
clinically significant valvular heart disease-

- Currently active infection

- Active peptic ulcer, incomplete wound healing or unhealed bone fracture

- Previous thromboembolic events, known hemorrhagic diathesis, coagulopathy with
increased bleeding risk, or treatment with anticoagulants Current or recent (within
10 days of first dose of bevacizumab) use of acetylic acid (>325mg/day) or
clopidogrel (> 75mg/day)

- Disease significantly affecting gastrointestinal function, e.g. mal- absorption
syndrome, resection of the stomach or small bowel, ulcerative colitis; abdominal
fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of

- Major surgery within the last 28 days or anticipation of the need for major surgery
during study treatment with bevacizumab. No minor surgeries including insertion of an
indwelling catheter within 24 h prior to randomization

- Parenchymal brain metastases, unless adequately controlled by surgery and/or
radiotherapy with complete resolution of symptoms and discontinuation of all steroids

- History of other malignancy within the last 5 years which could affect the diagnosis
or assessment or outcome of metastatic breast cancer

- Concurrent treatment with other experimental drugs; participation in another clinical
trial with any investigational drug within 30 days prior to study entry

- Treatment with sorivudine or derivates e.g. brivudine

- Pregnant or lactating patients. Patients of childbearing potential must implement
adequate non-hormonal contraceptive measures (barrier methods, intra uterine
contraceptive devices, sterilization) during study treatment

Type of Study:


Study Design:

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

Outcome Measure:

Progression free survival (PFS)

Outcome Description:

The PFS time is defined as time from randomization to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of: "death", "last tumor assessment", "last follow up date" or "last date in drug log"

Outcome Time Frame:

10 month

Safety Issue:


Principal Investigator

Hans-Joachim Lück, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

German Breast Group


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

GBG 43



Start Date:

July 2009

Completion Date:

October 2012

Related Keywords:

  • Breast Cancer
  • Palliative Therapy
  • bevacizimab
  • Avastin
  • Xeloda
  • metastatic breast cancer
  • Progression Free Survival
  • Time to Progression
  • Overall survival
  • Breast Neoplasms