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Status:

COMPLETED

Trastuzumab and Letrozole in Treating Postmenopausal Women With Progressive Advanced Breast Cancer

Lead Sponsor:

Swiss Cancer Institute

Conditions:

Breast Cancer

Eligibility:

FEMALE

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or...

Detailed Description

OBJECTIVES: Primary * Determine the efficacy of trastuzumab (Herceptin®) monotherapy followed by trastuzumab and letrozole in women with progressive advanced breast cancer that is resistant to prior...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed breast cancer
  • Advanced disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion outside previously irradiated areas that is ≥ 20 mm OR ≥ 10 mm if the slice thickness of the CT scan or MRI is ≤ 5 mm
  • No nonmeasurable lesions as the only site of measurable disease, including any of the following:
  • Osteoblastic bone metastases
  • Ascites
  • Pleural or pericardial effusions
  • Carcinomatous lymphangitis of the lung
  • Progressive disease after prior treatment with a nonsteroidal aromatase inhibitor (e.g., letrozole or anastrozole) in an adjuvant or advanced disease setting
  • HER-2 amplification ≥ 2 by fluorescence in situ hybridization
  • No clinical symptoms or history of CNS or leptomeningeal metastases (no imaging is required)
  • No visceral involvement with risk for organ dysfunction
  • Hormone receptor status:
  • Estrogen receptor- and/or progesterone receptor-positive tumor
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Sex
  • Female
  • Menopausal status
  • Postmenopausal, defined by 1 of the following:
  • At least 55 years of age
  • Less than 55 years of age with spontaneous cessation of menses for ≥ 1 year
  • Less than 55 years of age with spontaneous cessation of menses within the past year, but amenorrheic with biochemical evidence of postmenopausal status
  • Underwent prior bilateral oophorectomy
  • Radiation or chemically induced menopause (treatment with luteinizing hormone-releasing hormone antagonists must continue during study treatment)
  • Performance status
  • WHO 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • WBC ≥ 3,000/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • AST and ALT ≤ 2 times upper limit of normal
  • Renal
  • Creatinine clearance \> 30 mL/min
  • Cardiovascular
  • No uncontrolled cardiac disease, including any of the following:
  • Unstable angina
  • Arrhythmia
  • Hypertension
  • No history of congestive heart failure
  • No myocardial infarction within the past 6 months
  • LVEF \> 50% by echocardiogram
  • Pulmonary
  • No severe dyspnea at rest
  • Other
  • No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer
  • No psychiatric disability that would preclude study participation or giving informed consent
  • No active autoimmune disease
  • No uncontrolled diabetes
  • No other serious underlying medical condition that would preclude study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No prior trastuzumab (Herceptin®)
  • Chemotherapy
  • Prior neoadjuvant or adjuvant chemotherapy allowed
  • No prior palliative chemotherapy
  • Endocrine therapy
  • See Disease Characteristics
  • Radiotherapy
  • See Disease Characteristics
  • Surgery
  • Not specified
  • Other
  • More than 1 month since prior experimental drugs on another clinical trial
  • No concurrent drugs that contraindicate study treatment
  • No other concurrent anticancer drugs
  • No other concurrent investigational drugs

Exclusion

    Key Trial Info

    Start Date :

    May 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2011

    Estimated Enrollment :

    13 Patients enrolled

    Trial Details

    Trial ID

    NCT00238290

    Start Date

    May 1 2005

    End Date

    April 1 2011

    Last Update

    May 15 2019

    Active Locations (14)

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

    Page 1 of 4 (14 locations)

    1

    Kantonspital Aarau

    Aarau, Switzerland, CH-5001

    2

    Kantonsspital Baden

    Baden, Switzerland, CH-5404

    3

    Saint Claraspital AG

    Basel, Switzerland, CH-4016

    4

    Universitaetsspital-Basel

    Basel, Switzerland, CH-4031