Single arm study of the combination of biweekly Avastin and Docetaxel as the first line treatment for patients with locally recurrrent or metastatic breast cancer - Aino

• Conditions: Metastatic breast cancer, HER 2 negative; MedDRA version: 9.1Level: LLTClassification code 10065348Term: Breast adenocarcinoma metastatic

• Registration Number: EUCTR2008-003527-24-FI
• Lead Sponsor: Tampere University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-01
• Last Update Posted: 2 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1.Written informed consent (informed consent document to be approved by the Independent Ethics Committee [IEC]) obtained prior to any study-specific procedure
2.Age =18 years female
3.Able to comply with the protocol
4.Histologically or cytologically confirmed, HER2-negative, pre- or post-menopausal women with adenocarcinoma of the breast with measurable or non-measurable (bone only disease) metastatic disease, who are candidates for chemotherapy.
5.Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
6.Life expectancy of =12 weeks
7.Prior neo-/adjuvant chemotherapy is allowed. However, if 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.
8.Prior adjuvant taxane therapy is allowed, if disease free interval = 6 months after completion of adjuvant therapy
9.Previous hormonal therapy is allowed for adjuvant or mBC
10.Prior radiation therapy is allowed if:
-delivered in the adjuvant setting as a part of the treatment of early breast cancer
-delivered prior to study entry for the relief of metastatic bone pain provided that no more than 30% of marrow-bearing bone has been irradiated.
11.Adequate haematological function
-Absolute neutrophil count (ANC) =1.5 x 109/L AND
Platelet count =100 x 109/L AND
Haemoglobin =9 g/dL (may be transfused to maintain or exceed this level)
12.Adequate liver function
-Total bilirubin <1.5 x upper limit of normal (ULN) AND
AST, ALT <2.5 x ULN in patients without liver metastases; <5 x ULN in patients with liver metastases
13.Adequate renal function
Serum creatinine =1.5 x ULN or calculated creatinine clearance =50 mL/min AND
Urine dipstick for proteinuria <2+. Patients discovered to have =2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate =1 g of protein in 24 hours
14.International normalized ratio (INR) =1.5 and PTT =1.5 x ULN within 7 days prior to enrolment. Anticoagulation treatment not allowed.
15.If female, should not be pregnant or breast-feeding. Women with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 28 days prior to inclusion into the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous chemotherapy for mBC
2.Patients must have received no radiation therapy for the treatment of metastatic disease (apart from those who received it for the relief of metastatic bone pain and with the precautions mentioned above)
3.Evidence of CNS metastases (even if previously treated). If symptomatic, the patient should be scanned within 28 days prior to enrolment to rule out CNS metastases
4.Pre-existing peripheral neuropathy NCI CTC-AE Grade >2 at enrolment
5.Major surgery, significant traumatic injury within 28 days prior to enrolment or anticipation of the need for major surgery during study treatment
6.Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
7.Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (>325 mg/day)
8.Current or recent (within 10 days of first dose of bevacizumab) use of oral or parenteral anticoagulants or thrombolytic agents.
9.History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
10.Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg)
11.Clinically significant (i.e. active) cardiovascular disease for example CVA (=6 months before enrolment), myocardial infarction (=6 months before enrolment), unstable angina, congestive heart failure (CHF) NYHA Class =II, serious cardiac arrhythmia requiring medication during the study, which might interfere with regularity of the study treatment, or not controlled by medication
12.Non-healing wound, active peptic ulcer or bone fracture
13.History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
14.Past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated Basal and squamous cell carcinoma of the skin or In-situ carcinoma of the cervix
15.Treatment with any other investigational agent, or participation in another clinical drug trial within 28 days prior to enrolment
16.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
17.History of trombotic disorders within last six months prior to enrolment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified