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

Roswell Park Comprehensive Cancer Center

Status and phase: Terminated; Phase 2

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

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

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01754519

P30CA016056 (U.S. NIH Grant/Contract)

NCI-2009-01568 (Registry Identifier)

I 108907 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Treatment (radiation therapy)

Experimental group

Description:

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

Treatment:

Radiation: Radiation Therapy

Other: Quality-of-Life Assessment

Procedure: Therapeutic Conventional Surgery

Other: Laboratory Biomarker Analysis