Stage IIIA Breast Cancer Clinical Trial
Official title:
Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute | Cianna Medical, Inc., National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with adverse events as a measure of safety and tolerability | Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0. | Up to 2 years | Yes |
Primary | Quality-of-life assessments | Will be rated by patients using the POST-B, the Functional Assessment of Chronic Illness Therapy (FACIT), and the Skindex-16. | Up to 2 years | No |
Primary | Cosmetic differences in the treated breast | Will measure differences in the cosmetic size, shape, or texture of the breast. Cosmesis will be graded according to the Baker Scale. Patient reported cosmesis will also be evaluated using the Ontario Clinical Oncology Breast Cancer Questionnaire. | Up to 2 years | No |
Secondary | Locoregional control rate | Locoregional control will be calculated with confidence interval estimates and will be compared to historical control rates. | At 5 years | No |
Secondary | Overall survival | The overall survival will be analyzed using Kaplan-Meier method. | Up to 5 years | No |
Secondary | Disease specific survival | The disease specific survival will be analyzed using Kaplan-Meier method. | Up to 5 years | No |
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