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

NCT ID: NCT01754519

Last Updated: 2017-07-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-08-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (radiation therapy)

Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.

Group Type: EXPERIMENTAL

Therapeutic Conventional Surgery

Intervention Type: PROCEDURE

Undergo wide local excision breast surgery

Radiation Therapy

Intervention Type: RADIATION

Undergo SFRT

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Interventions

Therapeutic Conventional Surgery

Undergo wide local excision breast surgery

Intervention Type: PROCEDURE

Radiation Therapy

Undergo SFRT

Intervention Type: RADIATION

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Cancer Radiotherapy; Irradiate; Irradiated; Irradiation; RT; Quality of Life Assessment

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Cianna Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Mattson

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

NCI-2009-01568

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 108907

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA016056

Identifier Type: NIH

Identifier Source: secondary_id

View Link

I 108907

Identifier Type: -

Identifier Source: org_study_id