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

Primary Purpose

Ductal Breast Carcinoma In Situ, Estrogen Receptor Negative, Estrogen Receptor Positive

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Therapeutic Conventional Surgery
Radiation Therapy
Laboratory Biomarker Analysis
Quality-of-Life Assessment
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ductal Breast Carcinoma In Situ

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (radiation therapy)

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Locoregional Control Rate
Locoregional control will be calculated with confidence interval estimates and will be compared to historical control rates.
Overall Survival
The overall survival will be analyzed using Kaplan-Meier method.
Disease Specific Survival
The disease specific survival will be analyzed using Kaplan-Meier method.

Full Information

First Posted
November 23, 2012
Last Updated
June 7, 2017
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI), Cianna Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01754519
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
IDE not submitted
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI), Cianna Medical, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (radiation therapy)
Arm Type
Experimental
Arm Description
Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Undergo wide local excision breast surgery
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, RT
Intervention Description
Undergo SFRT
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Description
Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0.
Time Frame
Up to 2 years
Title
Quality-of-life Assessments
Description
Will be rated by patients using the POST-B, the Functional Assessment of Chronic Illness Therapy (FACIT), and the Skindex-16.
Time Frame
Up to 2 years
Title
Cosmetic Differences in the Treated Breast
Description
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.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Locoregional Control Rate
Description
Locoregional control will be calculated with confidence interval estimates and will be compared to historical control rates.
Time Frame
At 5 years
Title
Overall Survival
Description
The overall survival will be analyzed using Kaplan-Meier method.
Time Frame
Up to 5 years
Title
Disease Specific Survival
Description
The disease specific survival will be analyzed using Kaplan-Meier method.
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mattson
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

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

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