Clinical trial · Interventional
Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery
Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer
NCT01754519CI-TRIAL-00028530terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): IDE not submitted
Summary
Brief summary (as posted)
This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for breast cancer.
Conditions
Conditions (15)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Breast Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Estrogen Receptor Negative | — | UNRESOLVED | — |
| Estrogen Receptor Positive | — | UNRESOLVED | — |
| HER2/Neu Negative | — | UNRESOLVED | — |
| Invasive Cribriform Breast Carcinoma | Invasive Breast Cribriform Carcinoma | ALIAS | 0.90 |
| Invasive Ductal Carcinoma, Not Otherwise Specified | Invasive Breast Carcinoma of No Special Type | ALIAS | 0.90 |
| Lobular Breast Carcinoma In Situ | Breast Lobular Carcinoma In Situ | ALIAS | 0.90 |
| Mucinous Breast Carcinoma | Breast Mucinous Carcinoma | ALIAS | 0.90 |
| Papillary Breast Carcinoma | Breast Papillary Carcinoma |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (radiation therapy)
- description
- Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
- interventionNames
- Procedure: Therapeutic Conventional Surgery
- Radiation: Radiation Therapy
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
Primary outcomes (3)
- measure
- Number of Patients With Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- Up to 2 years
- description
- Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0.
- measure
- Quality-of-life Assessments
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Core needle biopsy (e.g. Mammotome, core, stereotactic, ultrasound guided) showing invasive mammary cancer (with or without concomitant ductal carcinoma or lobular carcinoma in situ) or ductal carcinoma in situ; acceptable histologic types of invasive mammary cancer include ductal, tubular, mucinous, papillary, cribriform and "NOS" (not otherwise specified); invasive lobular cancer is excluded * Age \>= 50 years and postmenopausal with no menses for at least one year prior to study enrollment * Age \> 70 years with invasive breast cancer clinical size =\< 3 cm OR Age 50 - 70 years with invasive breast cancer clinical size =\< 1.5 cm OR Age \>= 50 years and postmenopausal with any grade ductal carcinoma in situ (DCIS) clinical extent =\< 1.5 cm (clinical tumor size will be determined by pre-operative breast imaging-mammography, ultrasound and/or magnetic resonance imaging; in cases of multiple measurements, the largest recorded single dimension will be used to determine eligibility) * Hormone receptor status * Estrogen or progesterone receptor positive or * Estrogen and progesterone receptor negative and clinical tumor size =\< 1.0 cm * Human epidermal growth factor receptor 2 (HER2)/neu negative on the core biopsy analysis defined as 0 or 1+ by immunohistochemistry or not amplified by fluorescent in situ hybridization analysis * Tumor \>= 0.5 cm from skin as defined by breast ultrasound * Unicentric tumor * Axillary lymph nodes negative by pre-operative physical examination in all cases and pathologic examination from surgery for invasive disease * Negative surgical margins, defined as no margin-labeling ink on tumor cells from margin evaluation Exclusion Criteria: * Initial core biopsy showing invasive lobular cancer * Estrogen receptor and progesterone receptor negative tumor with clinical size \> 1 cm * Any Her 2+ breast cancer (immunohistochemistry 3+; or amplified by fluorescence in situ hybridization \[FISH\]) * Cancer in a patient with a known inherited susceptibility mutation in breast cancer (BRCA)1 or BRCA2 * Multicentric breast cancer (two foci of known cancer in the breast separated by greater than 5 cm, or in separate quadrants * Clinically or pathologically positive axillary lymph nodes * Any prior breast cancer * Prior breast radiation therapy
References
Publications (0)
Data not yet available
No reference posted for this study.