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Clinical Trials/EUCTR2010-023324-25-AT
EUCTR2010-023324-25-ATActive, not recruitingNot Applicable

Multicentre randomized phase II study of neoadjuvant trastuzumab plus docetaxel with and without bevacizumab and trastuzumab plus docetaxel plus non-pegylated liposome-encapsulated doxorubicin (NPLD) with and without bevacizumab in HER2-positive early breast cancer

ABCSG (Austrian Breast & Colorectal Cancer Study Group)0 sites100 target enrollmentStarted: February 17, 2011Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
100
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Male or female, age = 18 years.
  • •2. Pathologically confirmed invasive primary breast adenocarcinoma (except inflammatory breast cancer, T4d) scheduled for taxan containing neoadjuvant systemic treatment with or without palpable lymph nodes.
  • •3. Documented HER2 protein overexpression as determined by immunohistochemistry (IHC) 3+ or by demonstrated HER2/c-erbB2 gene amplification according to fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) of the primary tumor by a local laboratory.
  • •4. LVEF = 55% measured by echocardiography within 4 weeks before randomization.
  • •5. ECOG Performance Status = 1
  • •6. Able and willing to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
  • •7. Written informed consent, indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment.
  • •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 100
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

  • •Current Treatment
  • •1. Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine.
  • •2. Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) excluding inhaled steroids.
  • •3. Chronic daily treatment with aspirin and aspirin analogs (>325 mg/day) or clopidogrel (> 75 mg / day).
  • •4. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of the study treatment.
  • •5. Current or recent (within 30 days prior to randomization) treatment with another investigational drug or participation in another investigational study.
  • •6. Inadequate bone marrow function: absolute neutrophil count (ANC) < 1.5 x 109/L, platelet count < 100 x 109/L or hemoglobin (Hb) < 9 g/dL.
  • •7. Inadequate liver function: serum (total) bilirubin > upper limit of normal (ULN), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN, AST or ALT > 1.5 x ULN concurrent with serum alkaline phosphatase > 2.5 ULN.
  • •8. Inadequate renal function: Serum creatinine > 177 µmol/L or 2.0 mg/dL. If urine dipstick for proteinuria is = 2+ at baseline, the patient must undergo 24-hour urine collection and demonstrate = 1 g of protein/24 hr
  • •9. Patients not receiving anticoagulant medication who have activated partial thromboplastin time (aPTT) > 1.5 x ULN within 7 days prior to Day1 of the cycle 1.
  • •Concomitant Conditions
  • •10. Other malignancy within the last 5 years before randomization except for curatively treated carcinoma in situ of the cervix or non-melanomatous skin cancer
  • •11. Evidence of distance metastasis judged clinically and at least by chest-X-ray, liver-sonography and bone scan.If there is any clinical suspicion of brain metastasis, a computerized tomography (CT) scan or magnetic resonance imaging (MRI) of the brain must be conducted within 4 weeks prior to randomization.
  • •12. Serious concurrent disease which could affect compliance with the protocol or interpretation of results, including, but not limited to:
  • •Active infection requiring IV antibiotics.
  • •Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg).
  • •Clinically significant history of cardiovascular disease as indicated by: cerebrovascular accident or stroke; myocardial infarction; unstable angina; New York Heart Association (NYHA) (see Appendix 4) Grade II or greater congestive heart failure (CHF); cardiac arrhythmia requiring medication; clinically significant valvular heart disease.
  • •Dyspnea at rest necessitating supportive oxygen therapy or with significant pleural effusions.
  • •Poorly controlled diabetes mellitus.
  • •History or evidence upon physical/neurological examination of CNS disease unrelated to cancer (e.g. uncontrolled seizures) unless adequately treated with standard medical therapy.
  • •History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
  • •History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months of randomization.
  • •Serious non-healing wound, peptic ulcer, or bone fracture.
  • •Clinically significant malabsorption syndrome, ulcerative colitis, disease affecting GI function, resection of the stomach or small bowel, or inability to take oral medication.
  • •Uncorrected hypokalemia or hypomagnesemia.
  • •Organ allografts requiring immunosuppressive ther

Investigators

Sponsor
ABCSG (Austrian Breast & Colorectal Cancer Study Group)

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