Breast CancerPhase 3NCT01000662
Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor
A Phase 3 study testing Daily Radiation Therapy and Weekly Radiation Therapy in people with Breast Cancer, run by NYU Langone Health at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Daily Radiation Therapy and Weekly Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2009to 14 Jun 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bellevue Hospital Center
New York, New York, 10016
NYU Clinical Cancer Center
New York, New York, 10016
Tisch Hospital
New York, New York, 10016
About this study
Official title: Phase III Study Comparing Whole Breast Radiotherapy With a Daily Tumor Red Boost
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.
- Conditions
- Breast Cancer
- Being tested
- Daily Radiation Therapy, Weekly Radiation Therapy
- Keywords
- whole breast radiotherapy, tumor bed boost
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Radiation TherapyRadiation
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.
Weekly Radiation TherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 daily boost | Active comparator | Radiation Therapy Receives: Radiation: Daily Radiation Therapy |
| ARM 2 weekly boost | Active comparator | Radiation Therapy Receives: Radiation: Weekly Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 60
Secondary outcomes (12)
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.
Measured: Baseline
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".
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: At the end of Treatment, an average of 3 weeks
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.
Measured: 45-60 days after treatment
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".
Measured: End of Treatment
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".
Measured: 45-60 days after treatment
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.
Measured: At the end of Treatment, an average of 3 weeks
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.
Measured: 45-60 days after treatment
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"
Measured: End of Treatment
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."
Measured: 45-60 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2012
- Study completion14 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Perez, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000662
- Sponsor's protocol ID
- 09-0030
- Status last verified
- Jul 2020
- First submitted
- 9 Oct 2009
- Last updated
- 6 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 27131077Garsa 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 24161428Finkel 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study Comparing Whole Breast Radiotherapy With a Daily Tumor Red Boost
- ClinicalTrials.gov ID
- NCT01000662
- Acronym / sponsor ID
- 09-0030
- Conditions
- Breast Cancer
- Keywords
- whole breast radiotherapy, tumor bed boost
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Posted 29 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1 daily boost | Active comparator | Radiation: Daily Radiation TherapyRadiation Therapy |
| ARM 2 weekly boost | Active comparator | Radiation: Weekly Radiation TherapyRadiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Radiation Therapy15 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 | ARM 1 daily boost |
| Weekly Radiation Therapy15 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. | Radiation | ARM 2 weekly boost |
Primary outcome
Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)
Time frame: 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
12 secondary outcomes
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline
Time frame: Baseline
Score on "SF-36 v2 Vitality" Scale
Time frame: Baseline
Average Score on Brief Pain Inventory (BPI) Scale
Time frame: Baseline
Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale
Time frame: Baseline
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment
Time frame: At the end of Treatment, an average of 3 weeks
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS)
Time frame: 45-60 days after treatment
Score on "SF-36 v2 Vitality" Scale
Time frame: End of Treatment
Score on "SF-36 v2 Vitality" Scale 45-60 Days After Treatment
Time frame: 45-60 days after treatment
Average Score on Brief Pain Inventory (BPI)
Time frame: At the end of Treatment, an average of 3 weeks
Average Score on Brief Pain Inventory (BPI)
Time frame: 45-60 days after treatment
Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment
Time frame: End of Treatment
Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment
Time frame: 45-60 days after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27131077Cooper 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.
- Results publication: PubMed 24161428Garsa 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.
- Derived from this study: PubMed 27045811Finkel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Perez, MD principal investigator
NYU School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Daily Radiation Therapy and Weekly Radiation Therapy in people with Breast Cancer, run by NYU Langone Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG) (time frame: Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01000662, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020; AzTrials last refreshed its copy on 2 Nov 2026.