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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01754519
• Other study ID #: I 108907
• Secondary ID: NCI-2009-01568I
• Status: Terminated
• Phase: Phase 2
• First received: November 23, 2012
• Last updated: September 2, 2015
• Start date: May 2013
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• Carcinoma, Lobular
• 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

Intervention

Procedure:
• Therapeutic Conventional Surgery
Undergo wide local excision breast surgery

Radiation:
• Radiation Therapy
Undergo SFRT

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (3)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	Cianna Medical, Inc., National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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