CClinicalTrials.gg
Sign In
CompletedNCT01000662Updated Aug 6, 2020Results posted

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

A Phase 3 interventional study of Daily Radiation Therapy and Weekly Radiation Therapy in Breast Cancer, sponsored by NYU Langone Health. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-06.

Sponsored by NYU Langone Health · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
412
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

Keywords

  • whole breast radiotherapy
  • tumor bed boost
03

In context

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
412 participants (actual)

Study arms

  • Active comparator
    ARM 1 daily boost

    Radiation Therapy

    Radiation: Daily Radiation Therapy

  • Active comparator
    ARM 2 weekly boost

    Radiation Therapy

    Radiation: Weekly Radiation Therapy

Interventions

  • RadiationDaily 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.

  • RadiationWeekly 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.

06

What researchers measure

Primary outcomes

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

    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

Secondary outcomes

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

    Time frame: Baseline

  2. Score on "SF-36 v2 Vitality" Scale

    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

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

    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

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

    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

  5. Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of 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.

    Time frame: At the end of Treatment, an average of 3 weeks

  6. Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS)

    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

  7. Score on "SF-36 v2 Vitality" Scale

    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

  8. Score on "SF-36 v2 Vitality" Scale 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".

    Time frame: 45-60 days after treatment

  9. Average Score on Brief Pain Inventory (BPI)

    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

  10. Average Score on Brief Pain Inventory (BPI)

    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

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

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

    Time frame: End of Treatment

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

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

    Time frame: 45-60 days after treatment

07

Results

Posted May 29, 2015

Participant flow

Participant flow — Overall Study
MilestoneARM 1 Daily BoostARM 2 Weekly Boost
Started206206
Completed202198
Not completed48

Outcome measures

PrimaryNumber of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)

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
Reported as:
Number · participants
Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)
participantsARM 1 Daily BoostARM 2 Weekly Boost
Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)2216
SecondaryAverage Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at 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.

Time frame:
Baseline
Reported as:
Mean · score on a scale
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline
score on a scaleARM 1 Daily BoostARM 2 Weekly Boost
Functional Status6.89 ± 2.727.03 ± 2.74
Cosmetic Status9.71 ± 3.29.9 ± 3.32
Breast Specific Pain3.69 ± 1.283.87 ± 1.47
SecondaryScore on "SF-36 v2 Vitality" Scale

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
Reported as:
Mean · score on a scale
Score on "SF-36 v2 Vitality" Scale
score on a scaleARM 1 Daily BoostARM 2 Weekly Boost
Good Feeling2.56 ± 0.912.65 ± 0.95
Bad Feeling3.3 ± 0.883.3 ± 0.97
SecondaryAverage Score on Brief Pain Inventory (BPI) Scale

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
Reported as:
Mean · score on a scale
Average Score on Brief Pain Inventory (BPI) Scale
score on a scaleARM 1 Daily BoostARM 2 Weekly Boost
Average Score on Brief Pain Inventory (BPI) Scale1.46 ± 1.591.71 ± 1.65
SecondaryAverage Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale

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
Reported as:
Mean · score on a scale
Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale
score on a scaleARM 1 Daily BoostARM 2 Weekly Boost
Satisfaction on Breast Looks1.97 ± 0.781.96 ± 0.84
Satisfaction about Treatment1.47 ± 0.781.41 ± 0.71
Convenience of Care2.53 ± 2.382.84 ± 2.41
SecondaryAverage Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of 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.

Time frame:
At the end of Treatment, an average of 3 weeks
Reported as:
Mean · score on a scale
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment
score on a scaleARM 1 Daily BoostARM 2 Weekly Boost
Functional Status7.08 ± 2.727.56 ± 3.24
Cosmetic Status10.29 ± 3.1710.10 ± 3.11
Breast Specific Pain4.57 ± 1.344.51 ± 1.51
SecondaryAverage Score on Breast Cancer Treatment Outcomes Scale (BCTOS)

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
Reported as:
Mean · score on a scale
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS)
score on a scaleARM 1 Daily BoostARM 2 Weekly Boost
Functional Status6.93 ± 3.137.01 ± 2.79
Cosmetic Status10.17 ± 3.0710.00 ± 2.84
Breast Specific Pain3.94 ± 1.343.80 ± 1.40
SecondaryScore on "SF-36 v2 Vitality" Scale

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
Reported as:
Mean · score on a scale
Score on "SF-36 v2 Vitality" Scale
score on a scaleARM 1 Daily BoostARM 2 Weekly Boost
Good Feeling2.55 ± 0.873.59 ± 0.92
Bad Feeling3.32 ± 0.863.25 ± 0.99
SecondaryScore on "SF-36 v2 Vitality" Scale 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".

Time frame:
45-60 days after treatment
Reported as:
Mean · score on a scale
Score on "SF-36 v2 Vitality" Scale 45-60 Days After Treatment
score on a scaleARM 1 Daily BoostARM 2 Weekly Boost
Good Feeling2.46 ± 0.782.36 ± 0.91
Bad Feeling3.29 ± 0.923.45 ± 0.84
SecondaryAverage Score on Brief Pain Inventory (BPI)

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
Reported as:
Mean · score on a scale
Average Score on Brief Pain Inventory (BPI)
score on a scaleARM 1 Daily BoostARM 2 Weekly Boost
Average Score on Brief Pain Inventory (BPI)1.46 ± 1.591.66 ± 1.67
SecondaryAverage Score on Brief Pain Inventory (BPI)

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
Reported as:
Mean · score on a scale
Average Score on Brief Pain Inventory (BPI)
score on a scaleARM 1 Daily BoostARM 2 Weekly Boost
Average Score on Brief Pain Inventory (BPI)1.23 ± 1.511.37 ± 1.52
SecondaryScore on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment

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

Time frame:
End of Treatment
Reported as:
Mean · score on a scale
Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment
score on a scaleARM 1 Daily BoostARM 2 Weekly Boost
Breast Looks now2.12 ± 0.741.95 ± 0.82
Satisfaction about Treatment1.35 ± 0.681.33 ± 0.65
SecondaryScore on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment

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

Time frame:
45-60 days after treatment
Reported as:
Mean · score on a scale
Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment
score on a scaleARM 1 Daily BoostARM 2 Weekly Boost
Breast Looks now2.02 ± 0.731.94 ± 0.76
Satisfaction about Treatment1.33 ± 0.721.32 ± 0.67

Adverse events

Collected over Day 1 of radiation therapy to Day 60. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ARM 1 Daily Boost—0/202 (0%)89/202 (44.1%)
ARM 2 Weekly Boost—0/198 (0%)72/198 (36.4%)
Most frequent other events
Most frequent other events
EventARM 1 Daily BoostARM 2 Weekly Boost
Fibrosis (Grade 1)Reproductive system and breast disorders26/20217/198
Retraction/Atrophy (Grade 1)Skin and subcutaneous tissue disorders23/20223/198
Pigmentation Change (Grade 1)Skin and subcutaneous tissue disorders15/20213/198
Telangiectasia (Grade 1)Skin and subcutaneous tissue disorders13/2024/198
Pain (Grade 1)Reproductive system and breast disorders10/20212/198
Edema (Grade 1)Respiratory, thoracic and mediastinal disorders6/2022/198
Lymphedema (Grade 1)Blood and lymphatic system disorders0/2021/198

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)ARM 1 Daily BoostARM 2 Weekly BoostTotal
<=18 years000
Between 18 and 65 years155168323
>=65 years513889
Sex: Female, Male
Sex: Female, Male(Participants)ARM 1 Daily BoostARM 2 Weekly BoostTotal
Female206206412
Male000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ARM 1 Daily BoostARM 2 Weekly BoostTotal
American Indian or Alaska Native101
Asian191736
Native Hawaiian or Other Pacific Islander101
Black or African American212647
White158150308
More than one race000
Unknown or Not Reported61319
Region of Enrollment
Region of Enrollment(participants)ARM 1 Daily BoostARM 2 Weekly BoostTotal
United States206206412
08

Study locations

3 sites
  • Bellevue Hospital Center
    New York, New York 10016, United States
  • NYU Clinical Cancer Center
    New York, New York 10016, United States
  • Tisch Hospital
    New York, New York 10016, United States
09

References and documents

Publications

  • Cooper BT, Formenti-Ujlaki GF, Li X, Shin SM, Fenton-Kerimian M, Guth A, Roses DF, Hitchen CJ, Rosenstein BS, Dewyngaert JK, Goldberg JD, Formenti SC. Prospective Randomized Trial of Prone Accelerated Intensity Modulated Breast Radiation Therapy With a Daily Versus Weekly Boost to the Tumor Bed. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):571-8. doi: 10.1016/j.ijrobp.2015.12.373. Epub 2015 Dec 29. PubMed 27131077 ↗
  • Garsa AA, Ferraro DJ, DeWees TA, Deshields TL, Margenthaler JA, Cyr AE, Naughton M, Aft R, Gillanders WE, Eberlein T, Matesa MA, Ochoa LL, Zoberi I. A prospective longitudinal clinical trial evaluating quality of life after breast-conserving surgery and high-dose-rate interstitial brachytherapy for early-stage breast cancer. Int J Radiat Oncol Biol Phys. 2013 Dec 1;87(5):1043-50. doi: 10.1016/j.ijrobp.2013.09.009. Epub 2013 Oct 22. PubMed 24161428 ↗
  • Finkel MA, Cooper BT, Li X, Fenton-Kerimian M, Goldberg JD, Formenti SC. Quality of Life in Women Undergoing Breast Irradiation in a Randomized, Controlled Clinical Trial Evaluating Different Tumor Bed Boost Fractionations. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):579-89. doi: 10.1016/j.ijrobp.2016.02.004. Epub 2016 Feb 6. PubMed 27045811 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01000662
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Oct 23, 2009
Start date
Mar 2009
Primary completion
Jul 2012
Completion
Jun 14, 2017
Results posted
May 29, 2015
Last update
Aug 6, 2020

Study contacts

Carmen Perez, MD
principal investigator · NYU School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

NYU Langone Health

Start the discussion