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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) North Central Cancer Treatment Group International Breast Cancer Study Group Eastern Cooperative Oncology Group Southwest Oncology Group Cancer and Leukemia Group B European Organization for Research and Treatment of Cancer |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003140 |
Purpose
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works in treating women with breast cancer who have received tamoxifen for at least 5 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: letrozole Other: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | A Phase III Randomized Double Blind Study of Vorozole Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen |
| Estimated Enrollment: | 4700 |
| Study Start Date: | August 1998 |
| Estimated Primary Completion Date: | September 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients receive oral letrozole once daily.
|
Drug: letrozole
Given orally
|
|
Arm II: Placebo Comparator
Patients receive oral placebo once daily.
|
Other: placebo
Given orally
|
Hide Detailed DescriptionOBJECTIVES:
Primary
Secondary
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to receptor status (positive vs unknown), lymph node status (negative vs positive vs unknown), prior adjuvant chemotherapy (yes vs no), interval between last dose of aromatase inhibitor therapy and randomization (< 6 months vs 6 months-2 years), and duration of prior tamoxifen use (0 years vs < 2 years vs 2-4.5 years vs > 4.5 years). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, at 6 months, and then annually for 4.5 years.
Patients who complete ≥ 4.5 years of letrozole (arm I) and who did not experience recurrent disease or new primary breast cancer, including ductal carcinoma in situ, may participate in the double-blind, placebo-controlled, re-randomization portion of the study. Patients are stratified according to lymph node status at enrollment (negative vs positive vs unknown), prior adjuvant chemotherapy (yes vs no), and interval between last dose of letrozole and re-randomization (<6 months vs 6 months to 2 years). Common genetic single nucleotide polymorphisms for genes encoding proteins involved in pharmacokinetic and/or pharmacodynamic pathways for letrozole are analyzed in order to determine if these single nucleotide polymorphisms contribute to individual variation in toxicity and efficacy of letrozole therapy.
Quality of life is assessed as during the first randomization.
Patients are followed annually.
PROJECTED ACCRUAL: A total of 4,700 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary invasive breast carcinoma resected at time of original diagnosis
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Postmenopausal defined by one of the following:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 542 Study Locations| Study Chair: | Paul E. Goss, MD, PhD | Massachusetts General Hospital |
| Study Chair: | James N. Ingle, MD | Mayo Clinic |
| Study Chair: | Monica Castiglione-Gertsch, MD | University Hospital Inselspital, Berne |
| Study Chair: | Nicholas J. Robert, MD | Fairfax Northern Virginia Hematology Oncology, PC - Fairfax |
| Study Chair: | Silvana Martino, DO | John Wayne Cancer Institute at Saint John's Health Center |
| Study Chair: | Hyman B. Muss, MD | University of Vermont |
| Study Chair: | Martine J. Piccart-Gebhart, MD, PhD | Institut Jules Bordet |
More Information
| Study ID Numbers: | CDR0000065921, CAN-NCIC-MA17, CALGB-49805, E-JMA17, EORTC-10983, IBCSG-BIG97-01, NCCTG-JMA17, SWOG-JMA17, JRF-Vor-Int-10, NCCTG-CAN-MA17, SWOG-CAN-MA17 |
| Study First Received: | November 1, 1999 |
| Last Updated: | September 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003140 History of Changes |
| Health Authority: | Unspecified |
|
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
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Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Therapeutic Uses |
Breast Neoplasms Enzyme Inhibitors Letrozole Aromatase Inhibitors Pharmacologic Actions Breast Diseases |