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

• Sponsor: Roswell Park Cancer Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01754519
• Collaborator: National Cancer Institute (NCI) (NIH), Cianna Medical, Inc. (Industry)
• Enrollment: 1
• Location: 1
• Arm: 1
• Duration (Months): 27
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	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

Detailed Description

PRIMARY OBJECTIVE:

1. 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:

1. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• 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
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Quality of Life Assessment

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Adverse Events as a Measure of Safety and Tolerability [Up to 2 years]

   Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0.

2. Quality-of-life Assessments [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.

3. Cosmetic Differences in the Treated Breast [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

1. Locoregional Control Rate [At 5 years]

   Locoregional control will be calculated with confidence interval estimates and will be compared to historical control rates.

2. Overall Survival [Up to 5 years]

   The overall survival will be analyzed using Kaplan-Meier method.

3. Disease Specific Survival [Up to 5 years]

   The disease specific survival will be analyzed using Kaplan-Meier method.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roswell Park Cancer Institute
• ClinicalTrials.gov Identifier: NCT01754519
• Other Study ID Numbers: I 108907; NCI-2009-01568; I 108907; P30CA016056
• First Posted: Dec 21, 2012
• Last Update Posted: Jul 7, 2017
• Last Verified: Jun 1, 2017

• Additional relevant MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Ductal, Breast; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular

Study Results

Participant Flow

Arm/Group Title	Treatment (Radiation Therapy)
Arm/Group Description	Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. Therapeutic Conventional Surgery: Undergo wide local excision breast surgery Radiation Therapy: Undergo SFRT Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment (Radiation Therapy)
Arm/Group Description	Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. Therapeutic Conventional Surgery: Undergo wide local excision breast surgery Radiation Therapy: Undergo SFRT Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Overall Participants	1
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65 (NA)
Sex: Female, Male (Count of Participants)
Female	1 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All treated and eligible patients

Arm/Group Title	Treatment (Radiation Therapy)
Arm/Group Description	Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. Therapeutic Conventional Surgery: Undergo wide local excision breast surgery Radiation Therapy: Undergo SFRT Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Measure Participants	1
Count of Participants [Participants]	1 100%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.

Arm/Group Title	Treatment (Radiation Therapy)
Arm/Group Description	Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. Therapeutic Conventional Surgery: Undergo wide local excision breast surgery Radiation Therapy: Undergo SFRT Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Measure Participants	0

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.

Arm/Group Title	Treatment (Radiation Therapy)
Arm/Group Description	Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. Therapeutic Conventional Surgery: Undergo wide local excision breast surgery Radiation Therapy: Undergo SFRT Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Measure Participants	0

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.

Arm/Group Title	Treatment (Radiation Therapy)
Arm/Group Description	Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. Therapeutic Conventional Surgery: Undergo wide local excision breast surgery Radiation Therapy: Undergo SFRT Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Measure Participants	0

5. Secondary Outcome

Title	Overall Survival
Description	The overall survival will be analyzed using Kaplan-Meier method.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.

Arm/Group Title	Treatment (Radiation Therapy)
Arm/Group Description	Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. Therapeutic Conventional Surgery: Undergo wide local excision breast surgery Radiation Therapy: Undergo SFRT Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Measure Participants	0

6. Secondary Outcome

Title	Disease Specific Survival
Description	The disease specific survival will be analyzed using Kaplan-Meier method.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.

Arm/Group Title	Treatment (Radiation Therapy)
Arm/Group Description	Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. Therapeutic Conventional Surgery: Undergo wide local excision breast surgery Radiation Therapy: Undergo SFRT Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Measure Participants	0

Adverse Events

Arm/Group Title	Treatment (Radiation Therapy)
Arm/Group Description	Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. Therapeutic Conventional Surgery: Undergo wide local excision breast surgery Radiation Therapy: Undergo SFRT Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
All Cause Mortality
	Treatment (Radiation Therapy)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment (Radiation Therapy)
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	Treatment (Radiation Therapy)
	Affected / at Risk (%)	# Events
Total	1/1 (100%)
General disorders
Fibrosis	1/1 (100%)	1
Pain	1/1 (100%)	1
Injury, poisoning and procedural complications
Contusion	1/1 (100%)	1
Seroma	1/1 (100%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/1 (100%)	1
Musculoskeletal discomfort	1/1 (100%)	1
Reproductive system and breast disorders
Breast oedema	1/1 (100%)	1
Breast pain	1/1 (100%)	1

Limitations/Caveats

The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.