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Single Arm Study of the Combination of Biweekly Avastin and Docetaxel as the First Line Treatment for Patients With Metastatic Breast Cancer

Phase 2
18 Years
Open (Enrolling)

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Trial Information

Single Arm Study of the Combination of Biweekly Avastin and Docetaxel as the First Line Treatment for Patients With Metastatic Breast Cancer

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

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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Time Frame:

1-3 months

Safety Issue:


Principal Investigator

Pirkko-Liisa I Kellokumpu-Lehtinen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tampere University Hospital


Finland: Finnish Medicines Agency

Study ID:

EudraCT 2008-003527-24



Start Date:

January 2009

Completion Date:

December 2013

Related Keywords:

  • Neoplasms
  • breast cancer
  • metastatic
  • chemotherapy
  • bevacizumab
  • docetaxel
  • Phase II
  • first line chemotherapy
  • metastatic breast cancer patients
  • Breast Neoplasms
  • Neoplasms