Clinical trial · Interventional
Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer
QUADRANTECTOMY PLUS AXILLARY DISSECTION VERSUS QUADRANTECTOMY ALONE IN MAMMOGRAPHIC STAGE T1N0 BREAST CANCER PATIENTS AGED OVER 65 YEARS
NCT00002720CI-TRIAL-00012233completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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: Surgery to remove axillary lymph nodes may be an effective treatment for women with breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of therapy with or without axillary lymph node dissection following quadrantectomy in treating older women with stage I breast cancer that is estrogen receptor positive.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven stage I, invasive breast cancer * Hormone receptor status: * Estrogen receptor positive * Progesterone receptor positive or negative PATIENT CHARACTERISTICS: Age: * 65 to 80 Sex: * Female Menopausal status: * Postmenopausal Performance status: * Not specified Life Expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No serious disease that would preclude surgery * No other prior or concurrent malignancy except basal cell carcinoma or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: * Not specified
References
Publications (1)
- DERIVEDMartelli G, Boracchi P, Ardoino I, Lozza L, Bohm S, Vetrella G, Agresti R. Axillary dissection versus no axillary dissection in older patients with T1N0 breast cancer: 15-year results of a randomized controlled trial. Ann Surg. 2012 Dec;256(6):920-4. doi: 10.1097/SLA.0b013e31827660a8. PMID 23154393