Clinical trial · Interventional
Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy
Conservative Local Treatment Versus Mastectomy After Induction Chemotherapy In Locally Advanced Breast Cancer: A Randomized Phase III Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
RATIONALE: Breast-conserving treatments such as radiation therapy or limited surgery are less invasive than mastectomy and may improve the quality of life. It is not yet known if breast-conserving treatments are as effective as mastectomy followed by radiation therapy in treating locally advanced breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of breast-conserving therapy with mastectomy followed by radiation therapy in treating women who have locally advanced breast cancer that has been previously treated with chemotherapy.
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 |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed locally advanced breast cancer * T3 inoperable, N0-N2 * Any T, N2 * T4, N0-N2 * Inflammatory breast carcinoma * Prior treatment with 4-6 courses of standard induction chemotherapy or active investigational regimens completed within the past 4 weeks * Residual tumor size less than 5 cm * No fixed axillary lymph nodes * No multifocal or bilateral breast cancer * No clinical suspicion of extensive ductal carcinoma in situ * No unresolved skin edema * No distant metastases (including ipsilateral supraclavicular node) * Positive bone scan allowed provided there are no bone metastases on x-ray * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * Any age Sex: * Female Menopausal status: * Not specified Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * Neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 times normal * SGOT and SGPT no greater than 2 times normal * Alkaline phosphatase no greater than 2 times normal Renal: * Creatinine less than 1.5 times normal Other: * No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or adequately treated cone-biopsied carcinoma in situ of the cervix * No serious underlying medical illness that would preclude study * No psychiatric or addictive disorder that would preclude study * No contraindication to study treatment * Not pregnant * Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * No concurrent hormonal replacement therapy * No concurrent oral contraceptives Radiotherapy: * See Disease Characteristics * No prior radiotherapy for breast cancer Surgery: * No prior surgery for breast cancer other than biopsy for diagnosis confirmation Other: * No other prior systemic therapy for breast cancer
References
Publications (1)
- RESULTSinacki M, Jassem J, van Tienhoven G. Conservative local treatment versus mastectomy after induction chemotherapy in locally advanced breast cancer: a randomised phase III study (EORTC 10974/22002, LAMANOMA)--why did this study fail? Eur J Cancer. 2005 Dec;41(18):2787-8. doi: 10.1016/j.ejca.2005.06.027. Epub 2005 Nov 7. No abstract available. PMID 16274985