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Status:

WITHDRAWN

Chemotherapy and Hormone Therapy as First-Line Therapy in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer

Lead Sponsor:

Technical University of Munich

Conditions:

Breast Cancer

Eligibility:

FEMALE

Up to 74 years

Phase:

PHASE3

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Estrogen can cause the growth of breast c...

Detailed Description

OBJECTIVES: * Determine the optimal sequence of chemotherapy and endocrine therapy as first-line therapy in postmenopausal women with metastatic or locally advanced breast cancer that is potentially ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed breast cancer
  • Metastatic or locally advanced disease
  • Bilateral breast cancer allowed
  • Measurable or evaluable progressing metastases or local disease
  • No sclerotic bone metastases as only disease
  • Measurable or evaluable disease not in a previously irradiated area
  • No immediately life-threatening metastatic disease
  • No known HER2/neu positivity, as defined by either of the following:
  • 3+ by immunohistochemistry
  • HER2-positive by fluorescent in situ hybridization or chromogenic in situ hybridization
  • No known cerebral or leptomeningeal metastases
  • Hormone receptor status:
  • Estrogen and/or progesterone receptor positive tumor
  • PATIENT CHARACTERISTICS:
  • Female
  • Postmenopausal, as defined by any of the following:
  • Bilateral oophorectomy and amenorrhea \> 3 months
  • Radiation castration and amenorrhea \> 3 months
  • Spontaneous menopause and amenorrhea \> 12 months
  • Previous hysterectomy and age \> 55 years
  • ECOG performance status 0-2
  • Must be ambulant with organ function and performance status adequate for conventional combination chemotherapy
  • No serious hypersensitivity to letrozole or other components of study drug
  • No other prior or concurrent malignancy except for basal cell carcinoma or carcinoma in situ of the cervix
  • PRIOR CONCURRENT THERAPY:
  • No prior systemic treatment for recurrent or metastatic breast cancer
  • No other concurrent radiotherapy, endocrine therapy, cytotoxic therapy, or experimental therapy for cancer

Exclusion

    Key Trial Info

    Start Date :

    May 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00403182

    Start Date

    May 1 2006

    Last Update

    June 1 2012

    Active Locations (9)

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

    Page 1 of 3 (9 locations)

    1

    Kreiskrankenhaus

    Ebersberg, Germany, D-85560

    2

    Gynaekologische Gemeinschaftspraxis - Pause, Thiel & Neuhofer

    Freising, Germany, D-85354

    3

    Frauenklinik Universitaet Giessen

    Giessen, Germany, D-35392

    4

    Klinikum Ingolstadt

    Ingolstadt, Germany, 85049