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

This study has been terminated.
(IDE not submitted)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01754519
First Posted: December 21, 2012
Last Update Posted: July 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Cianna Medical, Inc.
Information provided by (Responsible Party):
Roswell Park Cancer Institute
  Purpose
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.

Condition Intervention Phase
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 Procedure: Therapeutic Conventional Surgery Radiation: Radiation Therapy Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Number of Patients With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 2 years ]
    Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0.

  • Quality-of-life Assessments [ Time Frame: Up to 2 years ]
    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 [ Time Frame: Up to 2 years ]
    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 [ Time Frame: At 5 years ]
    Locoregional control will be calculated with confidence interval estimates and will be compared to historical control rates.

  • Overall Survival [ Time Frame: Up to 5 years ]
    The overall survival will be analyzed using Kaplan-Meier method.

  • Disease Specific Survival [ Time Frame: Up to 5 years ]
    The disease specific survival will be analyzed using Kaplan-Meier method.


Enrollment: 1
Study Start Date: May 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (radiation therapy)
Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
Procedure: Therapeutic Conventional Surgery
Undergo wide local excision breast surgery
Radiation: Radiation Therapy
Undergo SFRT
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RT
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754519


Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Cianna Medical, Inc.
Investigators
Principal Investigator: David Mattson Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01754519     History of Changes
Other Study ID Numbers: I 108907
NCI-2009-01568 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 108907 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Submitted: November 23, 2012
First Posted: December 21, 2012
Results First Submitted: May 15, 2017
Results First Posted: June 6, 2017
Last Update Posted: July 7, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Breast Carcinoma In Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Lobular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary