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Status:

UNKNOWN

Docetaxel, Epirubicin, and Cyclophosphamide With or Without Trastuzumab in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery

Lead Sponsor:

Technical University of Munich

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them fr...

Detailed Description

OBJECTIVES: * Determine the efficacy of neoadjuvant therapy comprising docetaxel and trastuzumab (Herceptin®) and adjuvant therapy comprising epirubicin hydrochloride, cyclophosphamide, and trastuzum...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed primary carcinoma of the breast by core biopsy
  • Solitaire or multifocal disease, defined as tumor manifestations within a quadrant or distance between tumor manifestations measured bilaterally \< 4 cm, respectively
  • No multifocal primary tumor, defined as tumor manifestations in different quadrants or distance between tumor manifestations ≥ 4 cm
  • Locally advanced, operable disease
  • Primary tumor ≥ 2 cm by clinical examination or imaging (i.e., mammogram, MRI, or ultrasound)
  • Inflammatory breast cancer with bidimensionally measurable lesion, independent of nodal status, allowed
  • HER2 status meeting 1 of the following criteria:
  • HER2-positive disease
  • 3+ by immunohistochemistry (IHC) and/or positive by fluorescence in situ hybridization (FISH)
  • HER-2 negative disease
  • 0 or 1+ by IHC OR 2+ by IHC and negative by FISH
  • No distant metastases by clinical or imaging diagnosis
  • No prior breast cancer
  • Hormone receptor status not specified
  • PATIENT CHARACTERISTICS:
  • Female
  • Pre- or post-menopausal
  • ECOG performance status 0-2
  • Platelet count ≥ 100,000/mm\^3
  • Neutrophil count ≥ 1,500/mm\^3
  • Hemoglobin ≥ 10 g/dL
  • ALT and AST ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Bilirubin normal (unless due to clearly documented Gilbert's syndrome)
  • Not pregnant or nursing
  • Negative pregnancy test (for premenopausal women or women with a postmenopausal status for \< 1 year)
  • Fertile patients must use effective contraception
  • Adequate organ function for cytotoxic chemotherapy
  • No known hypersensitivity reaction to the study agents or incorporated substances
  • No known allergy or severe reactions to trastuzumab or its constituents (for patients with HER2-positive disease)
  • No preexisting motor or sensory neuropathy ≥ grade 2
  • No other invasive malignancy within the past 5 years that would preclude study compliance or affect the interpretation of study results
  • LVEF ≥ 55% by MUGA or echocardiography
  • No other serious illness or medical condition, including any of the following:
  • New York Heart Association class II-IV congestive heart failure
  • History of documented congestive heart failure
  • Unstable angina pectoris
  • Myocardial infarction within the past 12 months
  • Uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 180 mm Hg or diastolic BP \> 100 mm Hg)
  • Clinically significant valvular heart disease
  • High-risk, uncontrolled arrhythmias
  • Dyspnea at rest due to malignant or other disease
  • Condition that requires supportive oxygen therapy
  • Active serious uncontrolled infections
  • Uncontrolled diabetes
  • PRIOR CONCURRENT THERAPY:
  • No prior systemic therapy for cancer
  • No prior trastuzumab (Herceptin\^®) (for HER2-positive patients)
  • No other concurrent anticancer therapy
  • No other concurrent investigational drugs
  • No concurrent immunosuppressive therapy
  • No concurrent sex hormones
  • No concurrent corticosteroids unless for premedication
  • No concurrent bisphosphonates during active treatment with chemotherapy

Exclusion

    Key Trial Info

    Start Date :

    October 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    94 Patients enrolled

    Trial Details

    Trial ID

    NCT00398489

    Start Date

    October 1 2006

    Last Update

    November 9 2010

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Klinikum Bayreuth

    Bayreuth, Germany, D 95448

    2

    Universitaetsfrauenklinik - Koeln

    Cologne, Germany, D-50391

    3

    Klinikum Deggendorf

    Deggendorf, Germany, 94469

    4

    Klinikum der Friedrich-Schiller Universitaet Jena

    Jena, Germany, D-07743