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

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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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), September 2008
First Received: November 2, 2007 Last Updated: September 22, 2008 History of Changes
Sponsored by: International Breast Cancer Study Group

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00553410

Purpose
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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Letrozole
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
Disease-free survival (DFS) [ Designated as safety issue: No ]

Secondary Outcome Measures:
Overall survival [ Designated as safety issue: No ]

Distant DFS [ Designated as safety issue: No ]

Breast cancer-free interval [ Designated as safety issue: No ]

Sites of first DFS failure [ Designated as safety issue: No ]

Second (nonbreast) malignancies [ Designated as safety issue: No ]

Deaths without prior cancer events [ Designated as safety issue: No ]

Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 4800
Study Start Date: August 2007
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Detailed Description:
OBJECTIVES:

Primary

Compare the disease-free survival (DFS) of postmenopausal women treated with continuous letrozole for 5 years vs intermittent letrozole over a 5-year period.
Secondary

Compare overall survival of patients treated with these two regimens.
Compare distant DFS of these patients.
Compare breast cancer-free interval of these patients.
Compare sites of first DFS failure in these patients.
Compare second (nonbreast) malignancies in these patients.
Compare deaths without prior cancer events in these patients.
Compare adverse events resulting from these two regimens.
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.

Arm I: Patients receive oral letrozole daily for 5 years.
Arm II: Patients receive oral letrozole daily for the first 9 months of years 1 through 4, followed by 12 months in year 5.
After completion of study therapy, patients are followed annually.

Eligibility

Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

Criteria
DISEASE CHARACTERISTICS:

Confirmed diagnosis of prior operable, noninflammatory breast cancer meeting the following criteria:

Steroid hormone receptor-positive tumors (estrogen receptor and/or progesterone receptor), determined by immunohistochemistry, after primary surgery and before commencement of prior endocrine therapy
Prior local treatment including surgery with or without radiotherapy for primary breast cancer with no known clinical residual loco-regional disease
Following primary surgery, eligible patients must have had evidence of lymph node involvement either in the axillary or internal mammary nodes, but not supraclavicular nodes
Clinically disease-free
Must have completed 4-6 years of prior adjuvant selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs), or a sequential combination of both

When calculating 4-6 years, neoadjuvant endocrine therapy should not be included
No evidence of recurrent disease or distant metastatic disease
No prior bilateral breast cancer
PATIENT CHARACTERISTICS:

Female
Must be postmenopausal by any of the following criteria:

Patients of any age who have had a bilateral oophorectomy (including radiation castration AND amenorrheic for > 3 months)
Patients 56 years old or older with any evidence of ovarian function must have biochemical evidence of definite postmenopausal status (defined as estradiol, luteinizing hormone [LH], and follicle-stimulating hormone [FSH] in the postmenopausal range)
Patients 55 years old or younger must have biochemical evidence of definite postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal range)

Patients who have received prior luteinizing-hormone releasing-hormone (LHRH) analogues within the last year are eligible if they have definite evidence of postmenopausal status as defined above
Clinically adequate hepatic function
No bone fracture due to osteoporosis at any time during the 4-6 years of prior therapy
No prior or current malignancy except adequately treated basal cell or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, or contra- or ipsilateral in situ breast carcinoma
No other nonmalignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up
No psychiatric, addictive, or any other disorder that compromises compliance with protocol requirements
PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 12 months since prior and no other concurrent endocrine SERM/AI therapy
Any type of prior adjuvant therapy allowed including, but not limited to, any of the following:

Neoadjuvant chemotherapy
Neoadjuvant endocrine therapy
Adjuvant chemotherapy
Trastuzumab (Herceptin®)
Ovarian ablation
Gonadotropin releasing hormone analogues
Lapatinib ditosylate
No concurrent hormone-replacement therapy, bisphosphonates (except for treatment of bone loss), or any other investigational agent
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553410

Locations
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

Sponsors and Collaborators
International Breast Cancer Study Group
Investigators
Investigator: Melanie Schaerlig-Strausak International Breast Cancer Study Group

More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database

No publications provided

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 History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Study placed in the following topic categories:
Skin Diseases
Adjuvants, Immunologic
Breast Neoplasms
Letrozole
Aromatase Inhibitors
Hormones
Breast Diseases

Additional relevant MeSH terms:
Neoplasms by Site
Neoplasms
Breast Neoplasms
Breast Diseases
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Letrozole
Aromatase Inhibitors
Pharmacologic Actions