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Status:

COMPLETED

Combination Chemotherapy With or Without Capecitabine and/or Trastuzumab Before Surgery in Treating Women With Stage I, Stage II, or Stage III Breast Cancer

Lead Sponsor:

GBG Forschungs GmbH

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

Brief Summary

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

Detailed Description

OBJECTIVES: Primary * Compare the pathologic complete response rates in women with stage I-III primary breast cancer treated with neoadjuvant epirubicin hydrochloride, cyclophosphamide, and docetaxe...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed unilateral or bilateral primary breast cancer
  • Meets 1 of the following staging criteria:
  • Clinical stage T4 or T3 disease
  • Clinical stage T1 and pathologic stage N+ by sentinel lymph node biopsy OR clinical stage T2, N+ disease AND estrogen receptor (ER) or progesterone receptor (PR) positive tumor
  • ER and PR negative tumor (T1-4, N0-3, M0)
  • Disease confirmed by core biopsy
  • No fine-needle aspiration or incisional biopsy
  • Bidimensionally measurable disease\*
  • Tumor lesion palpable and measures ≥ 2 cm OR tumor lesion ≥ 1 cm in maximum diameter by sonography
  • For inflammatory disease, extent of inflammation can be used as measurable lesion NOTE: \*In patients with multifocal or multicentric breast cancer, the largest lesion should be measured
  • Candidate for adjuvant chemotherapy
  • No low- or moderate-risk patients who are doubtful candidates for adjuvant chemotherapy and do not fulfill the staging criteria
  • Known HER-2/neu status by core biopsy
  • HER-2/neu positive tumor is defined as +3 by immunohistochemistry \[IHC\] OR positive by fluorescence in situ hybridization (FISH)
  • No evidence of distant metastasis
  • Hormone receptor status:
  • ER- or PR-positive tumor OR ER- and PR-negative tumor
  • PATIENT CHARACTERISTICS:
  • No male patients
  • Menopausal status not specified
  • Karnofsky performance status 80-100%
  • Life expectancy ≥ 10 years (disregarding diagnosis of cancer)
  • Normal cardiac function confirmed by ECG
  • LVEF ≥ 55% by cardiac ultrasound
  • Neutrophil count ≥ 2,000/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 10 g/dL
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase (AP) ≤ 5 times ULN OR
  • AP ≤ 2.5 times ULN AND AST and/or ALT ≤ 1.5 times ULN
  • Creatinine ≤ 2 mg/dL
  • Creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No motor or sensory neuropathy ≥ grade 2
  • No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No New York Heart Association class II-IV congestive heart failure
  • No coronary artery disease
  • No history of myocardial infarction
  • No uncontrolled arterial hypertension (i.e., blood pressure ≥ 160/90 mm Hg despite antihypertensive therapy)
  • No rhythm abnormalities requiring permanent therapy
  • No history of significant neurological or psychiatric disorders including psychotic disorders, dementia, or seizures that would preclude giving informed consent
  • No active infection
  • No active peptic ulcer
  • No unstable diabetes mellitus or insulin-dependent type II diabetes mellitus
  • No other serious illness or medical condition
  • No known hypersensitivity reaction to investigational compounds or incorporated substances
  • No definite contraindications for the use of corticosteroids
  • No known dihydropyrimidine dehydrogenase deficiency
  • Must be fit for anthracycline/taxane-containing chemotherapy
  • PRIOR CONCURRENT THERAPY:
  • No prior chemotherapy for any malignancy
  • No prior radiation therapy for breast cancer
  • No concurrent bisphosphonates during chemotherapy
  • Bisphosphonates allowed postoperatively
  • No chronic treatment with corticosteroids unless it is initiated \> 6 months prior to study entry and is given at low doses (≤ 20 mg methylprednisolone or equivalent)
  • No concurrent amifostine during chemotherapy
  • No concurrent cardioprotectors (e.g., dexrazoxane) during chemotherapy
  • No concurrent sex hormone therapy
  • No concurrent virostatic agents (e.g., sorivudine or brivudine)
  • No concurrent aminoglycosides
  • No other concurrent experimental drugs or anticancer therapy
  • At least 30 days since prior participation in another clinical trial with any investigational (not marketed) drug

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    1500 Patients enrolled

    Trial Details

    Trial ID

    NCT00288002

    Start Date

    January 1 2005

    Last Update

    August 26 2013

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Universitaetsfrauenklinik Frankfurt

    Neu-Isenburg, Germany, D-63263