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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
N/A
Open (Enrolling)
Female
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


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.


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:

Interventional

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:

Yes

Principal Investigator

David Mattson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

I 108907

NCT ID:

NCT01754519

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

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263