Trial record 1 of 1 for:    NCT01754519
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Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery

This study is currently recruiting participants.
Verified February 2014 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01754519
First received: November 23, 2012
Last updated: February 25, 2014
Last verified: February 2014

November 23, 2012
February 25, 2014
May 2013
September 2014   (final data collection date for primary outcome measure)
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Toxicity as assessed by NCI CTC v 3.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Acute toxicities will be graded using the NCI CTC version 3.0.
  • Quality-of-life assessments [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Will be rated by patients using the POST-B, the Functional Assessment of Chronic Illness Therapy (FACIT), and the Skindex-16.
  • Cosmetic outcomes [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Cosmetic outcomes will be graded according to the Baker Scale.
  • Toxicity as assessed by National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0 [ Time Frame: 1 week post treatment ] [ Designated as safety issue: Yes ]
    Acute toxicities will be graded using the NCI CTC version 3.0.
  • Toxicity as assessed by NCI CTC v 3.0 [ Time Frame: 1 month post treatment ] [ Designated as safety issue: Yes ]
    Acute toxicities will be graded using the NCI CTC version 3.0.
  • Toxicity as assessed by NCI CTC v 3.0 [ Time Frame: 3 months post treatment ] [ Designated as safety issue: Yes ]
    Acute toxicities will be graded using the NCI CTC version 3.0.
  • Cosmetic outcomes [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Cosmetics outcomes will be graded according to the Baker Scale.
  • Cosmetic outcomes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Cosmetic outcomes will be graded according to the Baker Scale.
Complete list of historical versions of study NCT01754519 on ClinicalTrials.gov Archive Site
  • Locoregional control rate [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The overall survival will be analyzed using Kaplan-Meier method.
  • Disease specific survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The disease specific survival will be analyzed using Kaplan-Meier method.
Same as current
Not Provided
Not Provided
 
Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery
Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
  • Stage IIIA Breast Cancer
  • Stage IIIC Breast Cancer
  • Procedure: therapeutic conventional surgery
    Undergo wide local excision breast surgery
  • Radiation: radiation therapy
    Undergo SFRT
    Other Names:
    • irradiation
    • radiotherapy
    • therapy, radiation
  • Procedure: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
Experimental: Treatment (radiation therapy)
Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
Interventions:
  • Procedure: therapeutic conventional surgery
  • Radiation: radiation therapy
  • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
82
Not Provided
September 2014   (final data collection date for primary outcome measure)

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 =< 3cm 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 >= 0.5cm 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 5cm, or in separate quadrants
  • Clinically or pathologically positive axillary lymph nodes
  • Any prior breast cancer
  • Prior breast radiation therapy
Female
50 Years and older
No
Not Provided
United States
 
NCT01754519
I 108907, NCI-2009-01568, I 108907, P30CA016056
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: David Mattson Roswell Park Cancer Institute
Roswell Park Cancer Institute
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP