Clinical trial · Interventional
Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer
Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary clearance | Procedure | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Surgery w/ axillary clearance, tamox
- description
- 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.
- interventionNames
- Drug: tamoxifen citrate
- Procedure: conventional surgery
- Radiation: radiation therapy
- Procedure: Axillary clearance
- type
- EXPERIMENTAL
- label
- Surgery w/o axillary clearance, tamox
- description
- 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.
- interventionNames
- Drug: tamoxifen citrate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDPestalozzi 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. PMID 18458044
- RESULTInternational 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. PMID 16344321