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Status:

COMPLETED

Letrozole in Breast Cancer Who Have Received 5 Years of Aromatase Inhibitor Therapy

Lead Sponsor:

Canadian Cancer Trials Group

Collaborating Sponsors:

Eastern Cooperative Oncology Group

North Central Cancer Treatment Group

Conditions:

Breast Cancer

Eligibility:

FEMALE

Up to 120 years

Phase:

PHASE3

Brief Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether ...

Detailed Description

OBJECTIVES: Primary * To compare the disease-free survival of women with primary breast cancer treated with letrozole vs placebo after completing approximately 5 years (i.e., 4½ - 6 years) of aromat...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Previously diagnosed with primary breast cancer
  • Must have received 4½ - 6 years of aromatase inhibitor therapy (e.g., letrozole, anastrozole, or exemestane), either as initial therapy or after prior tamoxifen citrate, including treatment received as part of clinical trial CAN-NCIC-MA17
  • Completed aromatase inhibitor therapy ≤ 2 years ago
  • No metastatic or recurrent disease, contralateral breast cancer, or ductal carcinoma in situ in either breast, as determined by the following:
  • Clinical examination of the breast area, axillae, and neck within the past 60 days
  • Mammogram within the past 12 months\*
  • Chest x-ray within the past 60 days
  • Bone scan, if alkaline phosphatase \> 2 times normal and/or there are symptoms of metastatic disease AND confirmatory x-ray, if bone scan results are questionable, within the past 60 days
  • Abdominal ultrasound, liver scan, or CT scan of the abdomen within the past 60 days, if ALT, AST, or alkaline phosphatase \> 2 times normal NOTE: \*A baseline mammogram is not required for patients who have undergone bilateral complete mastectomy
  • Hormone-receptor status:
  • Estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) primary tumor at the time of diagnosis, defined as a tumor receptor content of \> 10 fmol/mg protein or receptor positive by immunocytochemical assay (for patients not previously enrolled on clinical trial CAN-NCIC-MA17)
  • ER+ and/or PR+ primary tumor OR hormone receptor status of primary tumor unknown (for patients previously enrolled on clinical trial CAN-NCIC-MA17)
  • PATIENT CHARACTERISTICS:
  • Menopausal status not specified
  • ECOG performance status 0-2
  • Life expectancy ≥ 5 years
  • WBC \> 3.0 x 10\^9/L OR granulocyte count (polymorphs + bands) ≥ 1.5 times 10\^9/L
  • Platelet count \> 100 x 10\^9/L
  • AST and/or ALT \< 2 times upper limit of normal (ULN)\*
  • Alkaline phosphatase \< 2 times ULN\*
  • Able (i.e. sufficiently fluent) and willing to complete quality-of-life questionnaires in either English or French (NCIC CTG participating centers)
  • Inability to complete questionnaires due to illiteracy in English or French, loss of sight, or other equivalent reason allowed
  • Accessible for treatment and follow-up
  • No other prior or concurrent malignancy except adequately treated, superficial squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or other cancer treated \> 5 years ago that is presumed cured NOTE: \*Elevated levels allowed provided imaging examinations have ruled out metastatic disease
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No concurrent selective estrogen receptor modulator (e.g., raloxifene, idoxifene)
  • No other concurrent anticancer therapy

Exclusion

    Key Trial Info

    Start Date :

    November 23 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 19 2017

    Estimated Enrollment :

    1918 Patients enrolled

    Trial Details

    Trial ID

    NCT00754845

    Start Date

    November 23 2004

    End Date

    April 19 2017

    Last Update

    August 25 2023

    Active Locations (43)

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

    Page 1 of 11 (43 locations)

    1

    BCCA - Cancer Centre for the Southern Interior

    Kelowna, British Columbia, Canada, V1Y 5L3

    2

    BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, Canada, V3V 1Z2

    3

    BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, Canada, V5Z 4E6

    4

    BCCA - Vancouver Island Cancer Centre

    Victoria, British Columbia, Canada, V8R 6V5