Ductal Breast Carcinoma In Situ, Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, Invasive Cribriform Breast Carcinoma, Invasive Ductal Carcinoma, Not Otherwise Specified, Lobular Breast Carcinoma In Situ, Mucinous Breast Carcinoma, Papillary Breast Carcinoma, Progesterone Receptor Positive, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIC Breast Cancer, Tubular Breast Carcinoma
Conditions
Brief summary
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.
Detailed description
PRIMARY OBJECTIVE: I. For select patients with early stage breast cancer undergoing wide local excision followed by single fraction radiation therapy (SFRT), we will evaluate rates of observer-rated toxicity, cosmetic outcomes and patient satisfaction, objective measures of toxicity and quality of life as well as delivery of intended dose. SECONDARY OBJECTIVE: I. Locoregional control reported at five years. OUTLINE: Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then every 6 months for 2 years.
Interventions
PROCEDURETherapeutic Conventional Surgery
Undergo wide local excision breast surgery
RADIATIONRadiation Therapy
Undergo SFRT
OTHERLaboratory Biomarker Analysis
Correlative studies
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Cianna Medical, Inc.
Roswell Park Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability | Up to 2 years | Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0. |
| Quality-of-life Assessments | Up to 2 years | Will be rated by patients using the POST-B, the Functional Assessment of Chronic Illness Therapy (FACIT), and the Skindex-16. |
| Cosmetic Differences in the Treated Breast | Up to 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Locoregional Control Rate | At 5 years | Locoregional control will be calculated with confidence interval estimates and will be compared to historical control rates. |
| Overall Survival | Up to 5 years | The overall survival will be analyzed using Kaplan-Meier method. |
| Disease Specific Survival | Up to 5 years | The disease specific survival will be analyzed using Kaplan-Meier method. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Radiation Therapy) Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
Therapeutic Conventional Surgery: Undergo wide local excision breast surgery
Radiation Therapy: Undergo SFRT
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Treatment (Radiation Therapy) |
|---|---|
| Age, Continuous | 65 years |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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.
Time frame: Up to 2 years
Population: The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.
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.
Time frame: Up to 2 years
Population: All treated and eligible patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Radiation Therapy) | Number of Patients With Adverse Events as a Measure of Safety and Tolerability | 1 Participants |
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.
Time frame: Up to 2 years
Population: The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.
Secondary
Disease Specific Survival
The disease specific survival will be analyzed using Kaplan-Meier method.
Time frame: Up to 5 years
Population: The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.
Secondary
Locoregional Control Rate
Locoregional control will be calculated with confidence interval estimates and will be compared to historical control rates.
Time frame: At 5 years
Population: The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.
Secondary
Overall Survival
The overall survival will be analyzed using Kaplan-Meier method.
Time frame: Up to 5 years
Population: The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.