Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01000662
• Collaborator: (none)
• Enrollment: 412
• Locations: 3
• Arms: 2
• Duration (Months): 99.4
• Patients Per Site: 137.3
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

All patients (with Stages 0-II breast cancer) will receive an accelerated three week regimen of prone whole breast radiotherapy. The study intends to test the hypothesis that a weekly boost to the tumor bed, delivered on Friday, before the weekend break, is as well tolerated as the daily boost during accelerated prone radiotherapy.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Radiation: Daily Radiation Therapy; Radiation: Weekly Radiation Therapy	Phase 3

Detailed Description

Arm 1 is a concomitant boost protocol over three weeks which has previously been evaluated in over 500 patients (NYU 03-30 and NYU 05-181) and has shown excellent tolerance, and results. Arm 2 evaluates a Weekend Boost Dose (WBD) regimen which may have a radiobiological advantage by counteracting tumor repopulation which can occur over the weekend break. At the time of registration in the study, patients will be randomized to either treatment arm and stratified according to pre or post-menopausal status and on previous chemotherapy received or not.

Study Design

• Study Type: Interventional
• Actual Enrollment: 412 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Phase III Study Comparing Whole Breast Radiotherapy With a Daily Tumor Red Boost
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jun 14, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ARM 1 daily boost Radiation Therapy	Radiation: Daily Radiation Therapy; 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Active Comparator: ARM 2 weekly boost Radiation Therapy	Radiation: Weekly Radiation Therapy; 15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG) [Day 60]

   Number of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost: 0 - no symptoms, 5 - death directly related to radiation effects

Secondary Outcome Measures

1. Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline [Baseline]

   BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = "No difference"; 2 = "Slight"; 3 = "Moderate"; 4 = "Large difference". The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.

2. Score on "SF-36 v2 Vitality" Scale [Baseline]

   SF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or "vitality," at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = "All of the time"; 2 = "Most of the time"; 3 = "Some of the time"; 4 = "A little of the time"; 5 = "None of the time".

3. Average Score on Brief Pain Inventory (BPI) Scale [Baseline]

   The BPI is a self-administered assessment tool used in pain management. The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain The total range is 1-10; the higher the score, the higher the pain level.

4. Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale [Baseline]

   4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor." The total range is 1-4; the higher the score, the lower the breast quality.

5. Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment [At the end of Treatment, an average of 3 weeks]

   BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = "No difference"; 2 = "Slight"; 3 = "Moderate"; 4 = "Large difference". The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.

6. Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) [45-60 days after treatment]

   BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = "No difference"; 2 = "Slight"; 3 = "Moderate"; 4 = "Large difference". The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.

7. Score on "SF-36 v2 Vitality" Scale [End of Treatment]

   SF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or "vitality," at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = "All of the time"; 2 = "Most of the time"; 3 = "Some of the time"; 4 = "A little of the time"; 5 = "None of the time".

8. Score on "SF-36 v2 Vitality" Scale 45-60 Days After Treatment [45-60 days after treatment]

   SF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or "vitality," at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = "All of the time"; 2 = "Most of the time"; 3 = "Some of the time"; 4 = "A little of the time"; 5 = "None of the time".

9. Average Score on Brief Pain Inventory (BPI) [At the end of Treatment, an average of 3 weeks]

   The BPI is a self-administered assessment tool used in pain management. The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain The total range is 1-10; the higher the score, the higher the pain level.

10. Average Score on Brief Pain Inventory (BPI) [45-60 days after treatment]

    The BPI is a self-administered assessment tool used in pain management. The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain The total range is 1-10; the higher the score, the higher the pain level.

11. Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment [End of Treatment]

    4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor"

12. Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment [45-60 days after treatment]

    4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor."

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pre or post-menopausal women with stage 0,I, and II breast cancer

• Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm

• Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (DCIS and Tumors <5mm do not require nodal assessment)

• At least 2 weeks from last chemotherapy

• Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document

Exclusion Criteria:

• Previous radiation therapy to the ipsilateral breast

• More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation

• Active connective tissue disorders, such as lupus or scleroderma

• Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free >3 years

• Pregnant or lactating women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bellevue Hospital Center	New York	New York	United States	10016
2	NYU Clinical Cancer Center	New York	New York	United States	10016
3	Tisch Hospital	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Carmen Perez, MD, NYU School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT01000662
• Other Study ID Numbers: 09-0030
• First Posted: Oct 23, 2009
• Last Update Posted: Aug 6, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by NYU Langone Health: whole breast radiotherapy; tumor bed boost

Study Results

Participant Flow

Arm/Group Title	ARM 1 Daily Boost	ARM 2 Weekly Boost
Arm/Group Description	Radiation Therapy 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.	Radiation Therapy 15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
Period Title: Overall Study
STARTED	206	206
COMPLETED	202	198
NOT COMPLETED	4	8

Baseline Characteristics

Arm/Group Title	ARM 1 Daily Boost	ARM 2 Weekly Boost	Total
Arm/Group Description	Radiation Therapy Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed. Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.	Radiation Therapy Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed. Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.	Total of all reporting groups
Overall Participants	206	206	412
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	155 75.2%	168 81.6%	323 78.4%
>=65 years	51 24.8%	38 18.4%	89 21.6%
Sex: Female, Male (Count of Participants)
Female	206 100%	206 100%	412 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.5%	0 0%	1 0.2%
Asian	19 9.2%	17 8.3%	36 8.7%
Native Hawaiian or Other Pacific Islander	1 0.5%	0 0%	1 0.2%
Black or African American	21 10.2%	26 12.6%	47 11.4%
White	158 76.7%	150 72.8%	308 74.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	6 2.9%	13 6.3%	19 4.6%
Region of Enrollment (participants) [Number]
United States	206 100%	206 100%	412 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)
Description	Number of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost: 0 - no symptoms, 5 - death directly related to radiation effects
Time Frame	Day 60

Outcome Measure Data

Analysis Population Description

Patients receiving either daily or weekly boost to radiation therapy

Arm/Group Title	ARM 1 Daily Boost	ARM 2 Weekly Boost
Arm/Group Description	Radiation Therapy Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed. Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.	Radiation Therapy Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed. Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
Measure Participants	202	198
Number [participants]	22 10.7%	16 7.8%

2. Secondary Outcome

Title	Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline
Description	BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = "No difference"; 2 = "Slight"; 3 = "Moderate"; 4 = "Large difference". The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ARM 1 Daily Boost	ARM 2 Weekly Boost
Arm/Group Description	Radiation Therapy 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.	Radiation Therapy 15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
Measure Participants	202	198
Functional Status	6.89 (2.72)	7.03 (2.74)
Cosmetic Status	9.71 (3.2)	9.9 (3.32)
Breast Specific Pain	3.69 (1.28)	3.87 (1.47)

3. Secondary Outcome

Title	Score on "SF-36 v2 Vitality" Scale
Description	SF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or "vitality," at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = "All of the time"; 2 = "Most of the time"; 3 = "Some of the time"; 4 = "A little of the time"; 5 = "None of the time".
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ARM 1 Daily Boost	ARM 2 Weekly Boost
Arm/Group Description	Radiation Therapy 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.	Radiation Therapy 15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
Measure Participants	202	198
Good Feeling	2.56 (0.91)	2.65 (0.95)
Bad Feeling	3.3 (0.88)	3.3 (0.97)

4. Secondary Outcome

Title	Average Score on Brief Pain Inventory (BPI) Scale
Description	The BPI is a self-administered assessment tool used in pain management. The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain The total range is 1-10; the higher the score, the higher the pain level.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ARM 1 Daily Boost	ARM 2 Weekly Boost
Arm/Group Description	Radiation Therapy 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.	Radiation Therapy 15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
Measure Participants	202	198
Mean (Standard Deviation) [score on a scale]	1.46 (1.59)	1.71 (1.65)

5. Secondary Outcome

Title	Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale
Description	4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor." The total range is 1-4; the higher the score, the lower the breast quality.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ARM 1 Daily Boost	ARM 2 Weekly Boost
Arm/Group Description	Radiation Therapy 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.	Radiation Therapy 15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
Measure Participants	202	198
Satisfaction on Breast Looks	1.97 (0.78)	1.96 (0.84)
Satisfaction about Treatment	1.47 (0.78)	1.41 (0.71)
Convenience of Care	2.53 (2.38)	2.84 (2.41)

6. Secondary Outcome

Title	Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment
Description	BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = "No difference"; 2 = "Slight"; 3 = "Moderate"; 4 = "Large difference". The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.
Time Frame	At the end of Treatment, an average of 3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ARM 1 Daily Boost	ARM 2 Weekly Boost
Arm/Group Description	Radiation Therapy 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.	Radiation Therapy 15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
Measure Participants	202	198
Functional Status	7.08 (2.72)	7.56 (3.24)
Cosmetic Status	10.29 (3.17)	10.10 (3.11)
Breast Specific Pain	4.57 (1.34)	4.51 (1.51)

7. Secondary Outcome

Title	Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS)
Description	BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = "No difference"; 2 = "Slight"; 3 = "Moderate"; 4 = "Large difference". The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.
Time Frame	45-60 days after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ARM 1 Daily Boost	ARM 2 Weekly Boost
Arm/Group Description	Radiation Therapy 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.	Radiation Therapy 15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
Measure Participants	202	198
Functional Status	6.93 (3.13)	7.01 (2.79)
Cosmetic Status	10.17 (3.07)	10.00 (2.84)
Breast Specific Pain	3.94 (1.34)	3.80 (1.40)

8. Secondary Outcome

Title	Score on "SF-36 v2 Vitality" Scale
Description	SF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or "vitality," at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = "All of the time"; 2 = "Most of the time"; 3 = "Some of the time"; 4 = "A little of the time"; 5 = "None of the time".
Time Frame	End of Treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ARM 1 Daily Boost	ARM 2 Weekly Boost
Arm/Group Description	Radiation Therapy 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.	Radiation Therapy 15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
Measure Participants	202	198
Good Feeling	2.55 (0.87)	3.59 (0.92)
Bad Feeling	3.32 (0.86)	3.25 (0.99)

9. Secondary Outcome

Title	Score on "SF-36 v2 Vitality" Scale 45-60 Days After Treatment
Description	SF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or "vitality," at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = "All of the time"; 2 = "Most of the time"; 3 = "Some of the time"; 4 = "A little of the time"; 5 = "None of the time".
Time Frame	45-60 days after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ARM 1 Daily Boost	ARM 2 Weekly Boost
Arm/Group Description	Radiation Therapy 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.	Radiation Therapy 15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
Measure Participants	202	198
Good Feeling	2.46 (0.78)	2.36 (0.91)
Bad Feeling	3.29 (0.92)	3.45 (0.84)

10. Secondary Outcome

Title	Average Score on Brief Pain Inventory (BPI)
Description	The BPI is a self-administered assessment tool used in pain management. The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain The total range is 1-10; the higher the score, the higher the pain level.
Time Frame	At the end of Treatment, an average of 3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ARM 1 Daily Boost	ARM 2 Weekly Boost
Arm/Group Description	Radiation Therapy 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.	Radiation Therapy 15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
Measure Participants	202	198
Mean (Standard Deviation) [score on a scale]	1.46 (1.59)	1.66 (1.67)

11. Secondary Outcome

Title	Average Score on Brief Pain Inventory (BPI)
Description	The BPI is a self-administered assessment tool used in pain management. The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain The total range is 1-10; the higher the score, the higher the pain level.
Time Frame	45-60 days after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ARM 1 Daily Boost	ARM 2 Weekly Boost
Arm/Group Description	Radiation Therapy 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.	Radiation Therapy 15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
Measure Participants	202	198
Mean (Standard Deviation) [score on a scale]	1.23 (1.51)	1.37 (1.52)

12. Secondary Outcome

Title	Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment
Description	4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor"
Time Frame	End of Treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ARM 1 Daily Boost	ARM 2 Weekly Boost
Arm/Group Description	Radiation Therapy 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.	Radiation Therapy 15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
Measure Participants	202	198
Breast Looks now	2.12 (0.74)	1.95 (0.82)
Satisfaction about Treatment	1.35 (0.68)	1.33 (0.65)

13. Secondary Outcome

Title	Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment
Description	4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor."
Time Frame	45-60 days after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ARM 1 Daily Boost	ARM 2 Weekly Boost
Arm/Group Description	Radiation Therapy 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.	Radiation Therapy 15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
Measure Participants	202	198
Breast Looks now	2.02 (0.73)	1.94 (0.76)
Satisfaction about Treatment	1.33 (0.72)	1.32 (0.67)

Adverse Events

Time Frame	Day 1 of radiation therapy to Day 60
Arm/Group Title	ARM 1 Daily Boost		ARM 2 Weekly Boost
Arm/Group Description	Radiation Therapy Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed. Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.		Radiation Therapy Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed. Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
All Cause Mortality
	ARM 1 Daily Boost		ARM 2 Weekly Boost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	ARM 1 Daily Boost		ARM 2 Weekly Boost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/202 (0%)		0/198 (0%)
Other (Not Including Serious) Adverse Events
	ARM 1 Daily Boost		ARM 2 Weekly Boost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	89/202 (44.1%)		72/198 (36.4%)
Blood and lymphatic system disorders
Lymphedema (Grade 1)	0/202 (0%)	0	1/198 (0.5%)	1
Reproductive system and breast disorders
Fibrosis (Grade 1)	26/202 (12.9%)	28	17/198 (8.6%)	17
Pain (Grade 1)	10/202 (5%)	10	12/198 (6.1%)	12
Respiratory, thoracic and mediastinal disorders
Edema (Grade 1)	6/202 (3%)	6	2/198 (1%)	2
Skin and subcutaneous tissue disorders
Pigmentation Change (Grade 1)	15/202 (7.4%)	18	13/198 (6.6%)	13
Retraction/Atrophy (Grade 1)	23/202 (11.4%)	25	23/198 (11.6%)	23
Telangiectasia (Grade 1)	13/202 (6.4%)	13	4/198 (2%)	4

Limitations/Caveats

[Not Specified]

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.