Biweekly Avastin and Docetaxel as the First Line Treatment for Patients With Metastatic Breast Cancer (AINO)

Tampere University Hospital

Status and phase

Terminated

Phase 2

Conditions

Neoplasms

Treatments

Drug: Docetaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00979641

EudraCT 2008-003527-24

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of the combination of biweekly docetaxel and bevacizumab in the first line treatment of metastatic breast cancer by using Response Evaluation Criteria In Solid Tumors (RECIST criteria) and NCI Common Terminology Criteria for Adverse Events (NCI CTC-AE) version 3. In addition several biochemical makers are tested as possible predictive factors.

Full description

Patients with histologically or cytologically proven measurable or nonmeasurable metastatic breast cancer are treated with a combination of biweekly docetaxel and bevacizumab as the first line treatment in multicenter phase II trial. The outcome measures would be PFS, Response rate (RECIST), duration of response, safety (NCI CTC-AE version 3) and survival. In addition several biochemical makers are tested as possible predictive factors. Treatment would be continued until PD, patient's refusal or treatment discontinuation due to side-effects or patients death. In responding patients bevacizumab would be continued either alone or in hormone receptor positive patients combined with hormone treatment until progression.

Enrollment

65 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 <or equal 1,5x ULN or calculated 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<or equal 1.5 and PTT< or equal 1.5 x ULN within 7 days prior to enrolment. 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