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Spots Global Cancer Trial Database for Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer

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Trial Identification

Brief Title: Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer

Official Title: Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.

Study ID: NCT00002528

Conditions

Breast Cancer

Study Description

Brief Summary: 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.

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.

Eligibility

Minimum Age: 60 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Royal Prince Alfred Hospital, Sydney, Sydney, New South Wales, Australia

Newcastle Mater Misericordiae Hospital, Waratah, New South Wales, Australia

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Anti-Cancer Council of Victoria, Melbourne, Parkville, Victoria, Australia

Sir Charles Gairdner Hospital, Perth, Perth, Western Australia, Australia

National Institute of Oncology, Budapest, , Hungary

Hadassah University Hospital, Jerusalem, , Israel

Centro di Riferimento Oncologico - Aviano, Aviano, , Italy

Spedali Civili, Brescia, , Italy

Presidio Ospedaliero-Gorizia, Gorizia, , Italy

Ospedale Civile Rimini, Rimini, , Italy

Ospedale San Eugenio, Rome, , Italy

Auckland Adventist Hospital, Auckland, , New Zealand

Institute of Oncology, Ljubljana, Ljubljana, , Slovenia

Groote Schuur Hospital, Cape Town, Cape Town, , South Africa

Sahlgrenska University Hospital, Gothenburg (Goteborg), , Sweden

University Hospital, Basel, , Switzerland

Inselspital, Bern, Bern, , Switzerland

Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland

Kantonsspital - St. Gallen, St. Gallen, , Switzerland

UniversitaetsSpital, Zurich, , Switzerland

Contact Details

Name: Diana Crivellari, MD

Affiliation: Centro di Riferimento Oncologico - Aviano

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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