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Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer

Phase 2
50 Years
Open (Enrolling)
Ductal Breast Carcinoma in Situ, Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Invasive Ductal Breast Carcinoma, Lobular Breast Carcinoma in Situ, Progesterone Receptor-positive Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer

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Trial Information

Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer


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.


I. Locoregional control reported at five years.


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.

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, cribiform and
"NOS"(Not Otherwise Specified); invasive lobular cancer is excluded

- Postmenopausal with no menses for at least one year prior to study enrollment

- Age > 70 years with invasive breast cancer clinical size =< 3cm OR Age 50 - 70 years
with invasive breast cancer clinical size =< 1.5 cm OR Age >= 50 years and
postmenopausal with low or intermediate 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 >= 0.5cm from skin as defined by breast ultrasound

- Unicentric tumor

- Axillary lymph nodes negative by pre-operative physical examination and negative
axillary lymph nodes by intraoperative touch prep cytology

- 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 FISH)

- Cancer in a patient with a known inherited susceptibility mutation in BRCA1 (breast
cancer susceptibility gene 1)or BRCA2(breast cancer susceptibility gene 2)

- Multicentric breast cancer (two foci of known cancer in the breast separated by
greater than 5cm, or in separate quadrants

- Clinically or pathologically positive axillary lymph nodes including touch
preparation cytology of sentinel nodes at time of surgery

- Any prior breast cancer

- Prior breast radiation therapy

Type of Study:


Study Design:

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

Outcome Measure:

Toxicity as assessed by National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0

Outcome Description:

Acute toxicities will be graded using the NCI CTC version 3.0.

Outcome Time Frame:

1 week post treatment

Safety Issue:


Principal Investigator

David Mattson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Institutional Review Board

Study ID:

I 108907



Start Date:

May 2013

Completion Date:

Related Keywords:

  • Ductal Breast Carcinoma in Situ
  • Estrogen Receptor-negative Breast Cancer
  • Estrogen Receptor-positive Breast Cancer
  • HER2-negative Breast Cancer
  • Invasive Ductal Breast Carcinoma
  • Lobular Breast Carcinoma in Situ
  • Progesterone Receptor-positive Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Lobular



Roswell Park Cancer InstituteBuffalo, New York  14263