Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery

Phase 2

Terminated

Conditions: Ductal Breast Carcinoma In Situ
Estrogen Receptor Negative
HER2/Neu Negative
Invasive Cribriform Breast Carcinoma
Papillary Breast Carcinoma
Progesterone Receptor Positive
Estrogen Receptor Positive
Stage II Breast Cancer
Stage IIIA Breast Cancer
Invasive Ductal Carcinoma, Not Otherwise Specified

Interventions: Procedure: Therapeutic Conventional Surgery
Radiation: Radiation Therapy
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment

Registration Number: NCT01754519

Lead Sponsor: Roswell Park Cancer Institute

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 1

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (radiation therapy)	Therapeutic Conventional Surgery	Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
Treatment (radiation therapy)	Radiation Therapy	Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
Treatment (radiation therapy)	Laboratory Biomarker Analysis	Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
Treatment (radiation therapy)	Quality-of-Life Assessment	Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.