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Sponsored by: |
International Breast Cancer Study Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00553410 |
RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is more effective in postmenopausal women who have received hormone therapy for early-stage breast cancer.
PURPOSE: This randomized phase III trial is comparing two different regimens of letrozole in preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for hormone receptor-positive, lymph node-positive, early-stage breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: letrozole |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized |
Official Title: | SOLE, Study of Letrozole Extension, A Phase III Trial Evaluating the Role of Continuous Letrozole Versus Intermittent Letrozole Following 4 to 6 Years of Prior Adjuvant Endocrine Therapy for Postmenopausal Women With Hormone-Receptor Positive, Node Positive Early Stage Breast Cancer |
Estimated Enrollment: | 4800 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | December 2021 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to treatment center and type of prior endocrine therapy (selective estrogen receptor modulators [SERMs] alone vs aromatase inhibitors [AIs] alone vs both SERMs and AIs each for at least 1 month). Patients are randomized to 1 of 2 treatment arms.
After completion of study therapy, patients are followed annually.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Confirmed diagnosis of prior operable, noninflammatory breast cancer meeting the following criteria:
Must have completed 4-6 years of prior adjuvant selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs), or a sequential combination of both
PATIENT CHARACTERISTICS:
Must be postmenopausal by any of the following criteria:
Patients 55 years old or younger must have biochemical evidence of definite postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal range)
PRIOR CONCURRENT THERAPY:
Any type of prior adjuvant therapy allowed including, but not limited to, any of the following:
Belgium | |
AZ Damiaan | Recruiting |
Oostende, Belgium, 8400 | |
Contact: Contact Person 32-59-553-404 | |
AZ Groeninge - Oncologisch Centrum | Recruiting |
Kortrijk, Belgium, 8500 | |
Contact: Contact Person 32-56-234-305 | |
AZ Klina | Recruiting |
Brasschaat, Belgium, 2930 | |
Contact: Contact Person 32-3-650- 5050 | |
AZ Nikolaas - Sint-Niklaas | Recruiting |
Sint-Niklaas, Belgium, 9100 | |
Contact: Contact Person 32-3-760-2985 | |
Centre Hospitalier de l'Ardenne | Recruiting |
Libramont, Belgium, 6800 | |
Contact: Contact Person 32-61-238-790 | |
Centre Hospitalier Hutois | Recruiting |
Huy, Belgium, 4500 | |
Contact: Contact Person 32-85-27-21-11 | |
Centre Hospitalier Peltzer-La Tourelle | Recruiting |
Verviers, Belgium, B-4800 | |
Contact: Contact Person 32-87-212-171 | |
Centre Hospitalier Universitaire Brugmann | Recruiting |
Brussels, Belgium, B 1020 | |
Contact: Contact Person 32-2-477-21-11 | |
Institut Jules Bordet | Recruiting |
Brussels, Belgium, 1000 | |
Contact: Contact Person 32-2-541-3082 | |
Clinique Saint Vincent | Recruiting |
Rocourt, Belgium, 4000 | |
Contact: Contact Person 32-4-239-4703 | |
Clinique Saint-Joseph | Recruiting |
Liege, Belgium, B 4000 | |
Contact: Contact Person 32-4-224-8990 | |
Clinique Saint-Pierre | Recruiting |
Ottignies, Belgium, B-1340 | |
Contact: Contact Person 32-10-437-211 | |
Cliniques du Sud Luxembourg | Recruiting |
Arlon, Belgium, 6700 | |
Contact: Contact Person 32-63-23-1111 | |
Cliniques Universitaires Saint-Luc | Recruiting |
Brussels, Belgium, 1200 | |
Contact: Contact Person 32-2-764-1111 | |
Imelda vzw, Ziekenhuis | Recruiting |
Bonheiden, Belgium, 2820 | |
Contact: Contact Person 32-15-505-011 | |
CHU Liege - Domaine Universitaire du Sart Tilman | Recruiting |
Liege, Belgium, B-4000 | |
Contact: Guy Jerusalem, MD, PhD 32-43-667-111 g.jerusalem@chu.ulg.ac.be | |
U.Z. Gasthuisberg | Recruiting |
Leuven, Belgium, B-3000 | |
Contact: Contact Person 32-16-34-46-34 | |
Virga Jesse Hospital | Recruiting |
Hasselt, Belgium, 3500 | |
Contact: Contact Person 32-11-309-960 | |
Hungary | |
National Institute of Oncology | Recruiting |
Budapest, Hungary, 1122 | |
Contact: Istvan Lang, MD, PhD, DSc 36-1-224-8763 lang@oncol.hu | |
Italy | |
Azienda Sanitaria di Bolzano | Recruiting |
Bolzano, Italy, 39100 | |
Contact: Contact Person 39-471-908-572 | |
Centro di Riferimento Oncologico - Aviano | Recruiting |
Aviano, Italy, 33081 | |
Contact: Contact Person 39-43-465-9653 | |
European Institute of Oncology | Recruiting |
Milano, Italy, 20141 | |
Contact: Marco Colleoni, MD 39-02-5748-9934 | |
Sweden | |
Sahlgrenska University Hospital | Recruiting |
Gothenburg, Sweden, S-413 45 | |
Contact: Per Karlsson, MD 46-31-342-1000 | |
Switzerland | |
Breast Center | Recruiting |
Zurich, Switzerland, CH-8008 | |
Contact: Contact Person 41-44-380-7660 | |
Tumor Zentrum ZeTup St. Gallen und Chur | Recruiting |
St. Gallen, Switzerland, CH-9006 | |
Contact: Contact Person 41-71-243-0043 | |
International Breast Cancer Study Group | Recruiting |
Bern, Switzerland, CH-3008 | |
Contact: Melanie Schaerlig-Strausak 41-31-389-9391 | |
Kantonspital Aarau | Recruiting |
Aarau, Switzerland, CH-5001 | |
Contact: Contact Person 41-62-838-6050 | |
Kantonsspital - St. Gallen | Recruiting |
St. Gallen, Switzerland, CH-9007 | |
Contact: Contact Person 41-71-494-1062 | |
Kantonsspital Freiburg | Recruiting |
Freiburg, Switzerland, 1708 | |
Contact: Contact Person 41-26-426-7111 | |
Ospedale Beata Vergine | Recruiting |
Mendrisio, Switzerland, CH-6850 | |
Contact: Olivia Pagani, MD 41-91-811-3395 | |
Regionalspital | Recruiting |
Thun, Switzerland, 3600 | |
Contact: Contact Person 41-33-226-2645 | |
Inselspital Bern | Recruiting |
Bern, Switzerland, CH-3010 | |
Contact: Stefan Aebi, MD 41-31-632-4114 stefan.aebi@insel.ch |
Investigator: | Melanie Schaerlig-Strausak | International Breast Cancer Study Group |
Study ID Numbers: | CDR0000574249, IBCSG-35-07, BIG-1-07-SOLE, EUDRACT-2007-001370-88 |
Study First Received: | November 2, 2007 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00553410 |
Health Authority: | Unspecified |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Skin Diseases Breast Neoplasms Letrozole Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Aromatase Inhibitors Pharmacologic Actions |