Trial record 18 of 2626 for:    hormone therapy AND (woman OR women OR female)

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 (SOLE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00553410
First received: November 2, 2007
Last updated: November 8, 2013
Last verified: November 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by International Breast Cancer Study Group:

Primary Outcome Measures:
  • Disease-free survival (DFS) [ Time Frame: estimated 10 years after first patient in ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: estimated 10 years after first patient in ] [ Designated as safety issue: No ]
  • Distant DFS [ Time Frame: estimated 10 years after first patient in ] [ Designated as safety issue: No ]
  • Breast cancer-free interval [ Time Frame: estimated 10 years after first patient in ] [ Designated as safety issue: No ]
  • Sites of first DFS failure [ Time Frame: estimated 10 years after first patient in ] [ Designated as safety issue: No ]
  • Second (nonbreast) malignancies [ Time Frame: estimated 10 years after first patient in ] [ Designated as safety issue: No ]
  • Deaths without prior cancer events [ Time Frame: estimated 10 years after first patient in ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: estimated 10 years after first patient in ] [ 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)
Arms Assigned Interventions
Active Comparator: Continuous letrozole
Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)
Drug: Letrozole
Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously
Experimental: Intermittent letrozole
Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months
Drug: Letrozole
Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months

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

Ages Eligible for Study:   18 Years and older
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 164 Study Locations
Sponsors and Collaborators
International Breast Cancer Study Group
Investigators
Study Chair: Marco Colleoni, MD European Institute of Oncology
  More Information

Additional Information:
No publications provided

Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT00553410     History of Changes
Other Study ID Numbers: CDR0000574249, IBCSG 35-07, BIG 1-07 SOLE, 2007-001370-88
Study First Received: November 2, 2007
Last Updated: November 8, 2013
Health Authority: Switzerland: Swissmedic
Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products
United States: Food and Drug Administration
Denmark: Danish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Chile: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
India:
Japan:
Peru:
Russia:
Slovenia:
South Africa:
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency

Keywords provided by International Breast Cancer Study Group:
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014