Clinical trial NCT01754519: Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery
Official title: Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Cianna Medical, Inc.
First posted: 2012-12-21
Enrollment: 1
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 2 years
measure: Quality-of-life Assessments
timeFrame: Up to 2 years
measure: Cosmetic Differences in the Treated Breast
timeFrame: Up to 2 years
Secondary outcomes:
measure: Locoregional Control Rate
timeFrame: At 5 years
measure: Overall Survival
timeFrame: Up to 5 years
measure: Disease Specific Survival
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: David Mattson
role: PRINCIPAL_INVESTIGATOR
References: