Single Arm Study of the Combination of Biweekly Avastin and Docetaxel as the First Line Treatment for Patients With Metastatic Breast Cancer
Inclusion Criteria:
- written informed concent
- age > or equal 18 years
- able to comply with the protocol
- histologically or cytologically confirmed, Her-2 negative, adenocarcinoma of the
breast with measurable or nonmeasurable metastatic disease, chemotherapy indicated
- ECOG 0-2, life expectancy of over or qual to 12 wks
- prior neo/adjuvant chemotherapy allowed
- prior adjuvant taxane therapy is allowed, DFS> or equal 6 months
- previous hormonal therapy allowed
- prior RT is allowed as adjuvant setting or to relief of metastatic bone pain, no more
than 30% of marrow-bearing bone irradiated
- Adequate haematological function
- adequate liver function total bilirubin <1.5 x upper limit of normal and AST,ALT <2.5
x ULN in patients without liver metastases; <5 x ULN in patients with liver
metastases
- adequate renal function serum creatinine
clearance > or equal 50mL/min and urine dipstick for proteinuria <2+. Patients
discovered to have or equal proteinuria or dipstick urinalysis at baseline should
undergo a 24 hour urine collection and must demonstrate < or equal 1 g of protein in
24 hours
- INR
Anticoagulation treatment not allowed
- if female, should not be pregnant or breast-feeding. Women with an intact uterus must
have a negative serum pregnancy test within 28 days prior to inclusion into the study
Exclusion Criteria:
- previous chemotherapy for mBC
- radiation therapy for the treatment of metastatic disease within 28 days
- evidence of CNS metastases. If symptomatic, the patient should be scanned within 28
days to enrolment to rule out CNS metastases
- pre-existing peripheral neuropathy NCI CTC-AE grade > 2 at enrolment
- major surgery, significant traumatic injury within 28 days prior to enrolment or
anticipation of the need for major surgery during study treatment
- Minor surgery, including insertion off an indwelling catheter, within 24 hours prior
to the first line bevacizumab infusion
- Current or recent(within 10 daÿs of first dose of bevacizumab) use of aspirin
(>325mg/day)
- current or recent (within 10 days of first dose of bevacizumab) use of oral or
parenteral anticoagulants or thrombolytic agents.
- history of evidence of inherited bleeding diathesis or coagulopathy with the risk of
bleeding
- uncontrolled hypertension (systolic >150mmHg and/or diastolic>100mmHg)
- Clinically significant cardiovascular disease for example CVA, myocardial infarction,
unstable angina, congestive heart failure NYHA Class > or equal II, serious cardiac
arrhythmia requiring medication during the study, which might interfere with
regularity of the study treatment, or not controlled by medication
- non- healing wound, active peptic ulcer or bone fracture
- history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
within 6 months of enrolment
- past of current history (within the last 5 years) of other malignancies except
curatively treated basal and squamous cell carcinoma of the skin or in-situ carcinoma
of the cervix
- treatment with any other investigational agent, or participation in another clinical
drug trial within 28 days prior to enrolment
- evidence of any other disease, neurological, psychiatric or metabolic dysfunction,
physical examination finding or laboratory finding giving reasonable suspicion of a
disease or condition that contraindicates the use of an investigational drug or puts
the patient at high risk for treatment-related complications
- history of thrombotic disorders within last six months