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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: | NCT00002528 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: tamoxifen citrate Procedure: conventional surgery Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | SURGICAL THERAPY WITH OR WITHOUT AXILLARY NODE CLEARANCE FOR BREAST CANCER IN THE ELDERLY WHO RECEIVE ADJUVANT THERAPY WITH TAMOXIFEN |
Study Start Date: | May 1993 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to whether they received prior primary surgery (yes vs no) and participating center.
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.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Australia, New South Wales | |
Newcastle Mater Misericordiae Hospital | |
Waratah, New South Wales, Australia, 2298 | |
Royal Prince Alfred Hospital, Sydney | |
Sydney, New South Wales, Australia, 2050 | |
Australia, South Australia | |
Royal Adelaide Hospital | |
Adelaide, South Australia, Australia, 5000 | |
Australia, Victoria | |
Anti-Cancer Council of Victoria, Melbourne | |
Parkville, Victoria, Australia, 3050 | |
Australia, Western Australia | |
Sir Charles Gairdner Hospital, Perth | |
Perth, Western Australia, Australia, 6009 | |
Hungary | |
National Institute of Oncology | |
Budapest, Hungary, 1125 | |
Israel | |
Hadassah University Hospital | |
Jerusalem, Israel, 91120 | |
Italy | |
Centro di Riferimento Oncologico - Aviano | |
Aviano, Italy, 33081 | |
Ospedale Civile Rimini | |
Rimini, Italy, 47900 | |
Ospedale San Eugenio | |
Rome, Italy, 00144 | |
Presidio Ospedaliero-Gorizia | |
Gorizia, Italy, 34170 | |
Spedali Civili | |
Brescia, Italy, 25124 | |
New Zealand | |
Auckland Adventist Hospital | |
Auckland, New Zealand, 5 | |
Slovenia | |
Institute of Oncology, Ljubljana | |
Ljubljana, Slovenia, Sl-1000 | |
South Africa | |
Groote Schuur Hospital, Cape Town | |
Cape Town, South Africa, 7925 | |
Sweden | |
Sahlgrenska University Hospital | |
Gothenburg (Goteborg), Sweden, S-413 45 | |
Switzerland | |
University Hospital | |
Basel, Switzerland, CH-4031 | |
Inselspital, Bern | |
Bern, Switzerland, CH-3010 | |
Kantonsspital - St. Gallen | |
St. Gallen, Switzerland, CH-9006 | |
UniversitaetsSpital | |
Zurich, Switzerland, CH-8091 | |
Centre Hospitalier Universitaire Vaudois | |
Lausanne, Switzerland, CH-1011 |
Study Chair: | Diana Crivellari, MD | Centro di Riferimento Oncologico - Aviano |
Study ID Numbers: | CDR0000078383, IBCSG-10-93, EU-93013, NCI-F93-0008 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002528 History of Changes |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer |
Estrogen Antagonists Estrogens Skin Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Citric Acid Adjuvants, Immunologic Hormones, Hormone Substitutes, and Hormone Antagonists |
Breast Neoplasms Bone Density Conservation Agents Selective Estrogen Receptor Modulators Tamoxifen Hormones Estrogen Receptor Modulators Breast Diseases |
Estrogen Antagonists Skin Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Tamoxifen Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Breast Diseases |