- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002528
Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer (10-93)
Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.
RATIONALE: Removing axillary lymph nodes may be effective in stopping the spread of breast cancer cells. It is not yet known if surgery to remove breast cancer is more effective with or without lymph node removal.
PURPOSE: Randomized phase III trial to compare the effectiveness of breast surgery with or without removal of axillary lymph nodes in treating women who have stage I or stage IIA breast cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Compare local and systemic disease-free survival, ipsilateral axillary relapse, occurrence of postmastectomy syndrome, and overall survival of elderly women with clinically operable stage I or IIA breast cancer who subsequently receive adjuvant tamoxifen after treatment with breast surgery with or without axillary node dissection.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to whether they received prior primary surgery (yes vs no) and participating center.
- Arm I: Patients undergo mastectomy, lumpectomy, or quadrantectomy with axillary clearance. Patients then receive oral tamoxifen for 5 years. Patients may also undergo sentinel node biopsy.
- Arm II: Patients undergo surgery as in arm I without axillary clearance. Patients then receive oral tamoxifen for 5 years.
Patients in both arms who undergo breast-conserving surgery may receive optional radiotherapy for 5-6 weeks to the remaining breast tissue, chest, and lung. Upon recurrence in the conserved breast, patients undergo total mastectomy; those in arm II who experience ipsilateral axillary recurrence undergo surgical excision. Adjuvant tamoxifen and follow up are continued.
Quality of life is assessed.
Patients are followed every 3 months for 1 year, every 6 months while receiving tamoxifen, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,020 patients will be accrued for this study within approximately 5 years.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
New South Wales
-
Sydney, New South Wales, Australia, 2050
- Royal Prince Alfred Hospital, Sydney
-
Waratah, New South Wales, Australia, 2298
- Newcastle Mater Misericordiae Hospital
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
-
-
Victoria
-
Parkville, Victoria, Australia, 3050
- Anti-Cancer Council of Victoria, Melbourne
-
-
Western Australia
-
Perth, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital, Perth
-
-
-
-
-
Budapest, Hungary, 1125
- National Institute of Oncology
-
-
-
-
-
Jerusalem, Israel, 91120
- Hadassah University Hospital
-
-
-
-
-
Aviano, Italy, 33081
- Centro di Riferimento Oncologico - Aviano
-
Brescia, Italy, 25124
- Spedali Civili
-
Gorizia, Italy, 34170
- Presidio Ospedaliero-Gorizia
-
Rimini, Italy, 47900
- Ospedale Civile Rimini
-
Rome, Italy, 00144
- Ospedale San Eugenio
-
-
-
-
-
Auckland, New Zealand, 5
- Auckland Adventist Hospital
-
-
-
-
-
Ljubljana, Slovenia, Sl-1000
- Institute of Oncology, Ljubljana
-
-
-
-
-
Cape Town, South Africa, 7925
- Groote Schuur Hospital, Cape Town
-
-
-
-
-
Gothenburg (Goteborg), Sweden, S-413 45
- Sahlgrenska University Hospital
-
-
-
-
-
Basel, Switzerland, CH-4031
- University Hospital
-
Bern, Switzerland, CH-3010
- Inselspital, Bern
-
Lausanne, Switzerland, CH-1011
- Centre Hospitalier Universitaire Vaudois
-
St. Gallen, Switzerland, CH-9006
- Kantonsspital - St. Gallen
-
Zurich, Switzerland, CH-8091
- UniversitaetsSpital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed stage I or IIA breast carcinoma that is considered operable
- No prior axillary clearance or biopsy
- Complete excisional biopsy of primary tumor without axillary clearance or biopsy allowed
- Suspicious manifestations of metastatic disease (e.g., hot spots on bone scan or skeletal pain of unknown cause) must be proven benign
- No bilateral breast cancer (any mass in contralateral breast must be proven benign by biopsy)
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 60 and over
Sex:
- Female
Menopausal status
- Postmenopausal
Performance status:
- Not specified
Hematopoietic:
- WBC greater than 4,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin less than 1.1 mg/dL
- AST less than 60 U/L
Renal:
- Creatinine less than 1.3 mg/dL
Cardiovascular:
- Normal cardiac function
- No history of congestive heart failure
Other:
- No nonmalignant systemic disease that would preclude protocol therapy or prolonged follow-up
- No psychiatric or addictive disorder that would preclude protocol therapy or informed consent
- No other prior or concurrent malignancy except nonmelanomatous skin cancer or adequately treated carcinoma in situ of the cervix
- Geographically accessible for follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic therapy for breast cancer
Chemotherapy:
- No prior chemotherapy for breast cancer
Endocrine therapy:
- No prior endocrine therapy for breast cancer
Radiotherapy:
- No prior radiotherapy for breast cancer
Surgery:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Surgery w/ axillary clearance, tamox
Either a total mastectomy with axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) with axillary lymph node dissection, and tamoxifen (20 mg) given after surgery for the duration of 5 years or until relapse.
|
20 mg daily beginning within 6 weeks of surgery for 5 years or until relapse, whichever occurs first.
Either total mastectomy or, optionally if the tumor was smaller than 5 cm, a breast conserving procedure (lumpectomy or quadrantectomy).
No radiotherapy is to be given after mastectomy.
Radiotherapy is optional after breast conserving surgery according to prospectively determined guidelines within each institution.
It should be given to the breast only and not to the draining node areas.
Axillary node dissection.
|
Experimental: Surgery w/o axillary clearance, tamox
Either a total mastectomy without axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) without axillary lymph node dissection, and tamoxifen (20 mg) given after surgery for the duration of 5 years or until relapse.
|
20 mg daily beginning within 6 weeks of surgery for 5 years or until relapse, whichever occurs first.
Either total mastectomy or, optionally if the tumor was smaller than 5 cm, a breast conserving procedure (lumpectomy or quadrantectomy).
No radiotherapy is to be given after mastectomy.
Radiotherapy is optional after breast conserving surgery according to prospectively determined guidelines within each institution.
It should be given to the breast only and not to the draining node areas.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-free survival
Time Frame: 17 years from randomization
|
Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.
|
17 years from randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 17 years from randomization
|
Time from randomization to death.
|
17 years from randomization
|
Toxicity
Time Frame: 17 years from randomization
|
Side effects of treatment, especially surgery-related events.
|
17 years from randomization
|
Quality of life
Time Frame: 17 years from randomization
|
Quality of life will be assessed by standard International Breast Cancer Study Group instruments
|
17 years from randomization
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Diana Crivellari, MD, Centro di Riferimento Oncologico - Aviano
Publications and helpful links
General Publications
- Pestalozzi BC, Zahrieh D, Mallon E, Gusterson BA, Price KN, Gelber RD, Holmberg SB, Lindtner J, Snyder R, Thurlimann B, Murray E, Viale G, Castiglione-Gertsch M, Coates AS, Goldhirsch A; International Breast Cancer Study Group. Distinct clinical and prognostic features of infiltrating lobular carcinoma of the breast: combined results of 15 International Breast Cancer Study Group clinical trials. J Clin Oncol. 2008 Jun 20;26(18):3006-14. doi: 10.1200/JCO.2007.14.9336. Epub 2008 May 5.
- International Breast Cancer Study Group; Rudenstam CM, Zahrieh D, Forbes JF, Crivellari D, Holmberg SB, Rey P, Dent D, Campbell I, Bernhard J, Price KN, Castiglione-Gertsch M, Goldhirsch A, Gelber RD, Coates AS. Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer: first results of International Breast Cancer Study Group Trial 10-93. J Clin Oncol. 2006 Jan 20;24(3):337-44. doi: 10.1200/JCO.2005.01.5784. Epub 2005 Dec 12.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Tamoxifen
Other Study ID Numbers
- CDR0000078383
- IBCSG-10-93
- EU-93013
- NCI-F93-0008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
Clinical Trials on tamoxifen citrate
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedBreast Cancer | Stage IV Breast CancerUnited States, Canada, Peru
-
Northwestern UniversityNational Cancer Institute (NCI)CompletedEstrogen Receptor-positive Breast Cancer | Ductal Breast Carcinoma in SituUnited States
-
TYK Medicines, IncRecruiting
-
University of NottinghamUnknown
-
University of Texas Southwestern Medical CenterNational Cancer Institute (NCI)TerminatedBreast CancerUnited States
-
University Hospital BirminghamUnknown
-
National Medical Research Council (NMRC), SingaporeCompletedLiver CancerNew Zealand, Hong Kong, Indonesia, Malaysia, Pakistan, Singapore
-
Stanley Medical Research InstituteCompleted
-
European Institute of OncologyCompleted
-
The Cleveland ClinicNational Cancer Institute (NCI)CompletedBreast Cancer | Hereditary Breast/Ovarian Cancer (brca1, brca2)