Breast CancerPhase 2NCT02700386
Shorter Course Radiation for the Treatment of Breast Cancer That Has Spread to Lymph Nodes
A Phase 2 study testing Adjuvant Hypofractionated Radiation in people with Breast Cancer, run by University of Colorado, Denver at 3 sites in United States.
Trial summary
The proposed study is being done to learn more about a particular dose of radiation treatment for breast cancer that is completed in a shorter amount of time than what has traditionally been used to treat breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 101 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Adjuvant Hypofractionated Radiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Aug 2016to 13 Jun 2024
- Phase
- Phase 2
- 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 to 101 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women (≥18 years old) with breast cancer who have undergone surgery for their primary breast tumor (either lumpectomy or mastectomy +/- reconstruction) and are confirmed to have involved lymph nodes on surgical pathology.
- Patient who have undergone either a total mastectomy or a lumpectomy are eligible.
- Acceptable procedures for assessment of axillary nodal status at the time of surgery include:
- axillary node dissection;
- sentinel node biopsy alone; or
- sentinel node biopsy followed by axillary node dissection.
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- Eligible women include AJCC (American Joint Committee on Cancer) 7th ed. Stage cN0 or cN1 subsequently staged after surgery as Stage pIB (N1mic), pIIA, pIIB, pIIIA, pIIIB, or N3a (10 or more axillary nodes) only: note that ypN0 will also be eligible if pathologic confirmation of nodal involvement was documented prior to neoadjuvant chemotherapy and the patient was found to be node-negative at the time of surgery. Note that women less than 50 years of age, women who received chemotherapy, patients staged as pN0 (i+ or mol+), and large-breasted women are eligible for enrollment.
- The patient must have recovered from surgery with the incision completely healed and no signs of infection. If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved. The patient must have an ECOG performance status of 0 or 1 (KPS >70%).
- The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 180 days if chemotherapy is not delivered adjuvantly. If adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 180 days.
- Before the patient is enrolled, the consent form, including any addenda, must be signed and dated by the patient and the person who explains the study to that patient.
- Subjects will have the ability to understand, and the willingness to sign a written informed consent document.
Who cannot join
- patients <18 years old
- pregnant women
- male patients
- women with T4 disease, including inflammatory breast cancer
- women who have declined or otherwise not received preceding surgery
- women with positive margins after primary surgery
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- women with node-negative disease
- women without histologic confirmation of nodal involvement
- women more than 180 days out from primary breast surgery or adjuvant chemotherapy
- patients with clinically detected or suspicious lymph node involvement not readily amenable to surgical treatment (≥cN2 disease)
- patients with synchronous bilateral breast cancers
- patients with prior ipsilateral thoracic or breast radiation
- patients with distant metastatic disease (cM1) or a life expectancy of less than 5 years
- active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma.
- other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
- patients with psychiatric or addictive disorders or other conditions that, in the opinion of the Investigator, would preclude the patient from meeting the study requirements.
- patients with a separate non-cutaneous cancer diagnosis for which the patient has not been without evidence of disease for at least 5 years.
- Note: women <50 years of age, women who received chemotherapy, pN0 (i+ or mol+), and large-breasted women are eligible for enrollment.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Hospital
Aurora, Colorado, 80045
Memorial Hospital
Colorado Springs, Colorado, 80909
Poudre Valley Hospital
Fort Collins, Colorado, 80524
About this study
Official title: Hypofractionated, Comprehensive Radiation Therapy for Node-Positive Breast Cancer
The proposed study is being done to learn more about a particular dose of radiation treatment for breast cancer that is completed in a shorter amount of time than what has traditionally been used to treat breast cancer. Subjects are being asked to be in this research study because they have already had surgery for breast cancer and some cancer cells were found in their lymph nodes that drain the breast tissue.
Read the detailed description
Subjects who join the study will receive a shortened course of radiation treatment that will last approximately four (4) weeks, instead of the traditional six (6) week course that women have typically received in this situation. The shorter course subjects will receive is designed in a way that it is thought to be equivalent to the longer course. This shorter course has already been shown to be very safe and effective when treating breast cancer in the breast tissue only. However, because cancer cells were found in the lymph nodes that drain their breast, subjects require radiation to a larger area of their chest, armpit, and shoulder than has been completely tested with this experimental dose.
- Conditions
- Breast Cancer
- Being tested
- Adjuvant Hypofractionated Radiation
- Keywords
- Breast, Cancer, Hypofractionated, Node-Positive Breast Cancer, Radiation Therapy, Comprehensive Radiation Therapy
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant Hypofractionated RadiationCombination product
Also called Radiation Therapy
Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Hypofractionated Radiation | Experimental | Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions. Receives: Combination Product: Adjuvant Hypofractionated Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least One Treatment-related Adverse Event of Interest
The composite endpoint is "yes" for a given patient if that patient experienced at least one of six component adverse events: lymphedema, shoulder ROM impairment, cardiac ischemia, symptomatic rib fracture, brachial plexopathy Grade 2 ('moderate symptoms; limiting instrumental activity of daily living (ADL)') or Grade 3 ('severe symptoms; limiting self-care ADL'), or Grade 2 pneumonitis (requires steroids). AEs were assessed by CTCAE version 4.03.
Measured: 12 months and 36 months
Number of Participants With Lymphedema Severity by Measuring Interlimb Circumference
An increase in interlimb arm circumference of at least 10% in the lower arm or the upper arm, or both, compared with the contralateral arm at the same timepoint, will be judged to be clinically significant lymphedema. Arm circumference 15 cm above the medial epicondyle (upper arms) and 15 cm below the medial epicondyle (lower arms) will be assessed at 12 months and at 36 months.
Measured: 12 months and 36 months
Number of Participants With Symptomatic Rib Fracture as Measured by Plain Film or CT
Symptomatic rib fracture will be diagnosed by evidence of a correlative lesion on plain film or CT.
Measured: 12 months and 36 months
Number of Participants With New Development of Ischemic Heart Disease as Measured by EKG
Ischemic heart disease will be measured by the new development of angina with corresponding EKG changes, or myocardial infraction.
Measured: 12 months and 36 months
Number of Participants Reporting Shoulder Stiffness as Measured by the EORTC QLQ-BR23
Shoulder stiffness severity is assessed using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire breast cancer module (EORTC QLQ-BR23). It is assessed based on patient response to the questionnaire item, "During the past week, was it difficult to raise your arm or to move it sideways?", which is scored from 1 to 4 with 1 being "not at all" and 4 being "very much". Shoulder stiffness is identified in a patient when their response to that question is 3 or 4 AND if their response increased numerically from their response on day 1.
Measured: 12 months and 36 months
Number of Participants With Grade 2 or Higher Pneumonitis
Number of patients who experience pneumonitis as an adverse event at Grade 2 or higher as assessed by CTCAE v 4.03.
Measured: 12 months and 36 months
Number of Participants With Grade 2 or Higher Brachial Plexopathy
Number of patients who experience brachial plexopathy as an adverse event at Grade 2 or higher as assessed by CTCAE v 4.03.
Measured: 12 months and 36 months
Secondary outcomes (5)
Number of Participants With Disease Recurrence
Recurrent disease presentation within axillary lymph node levels I, II, or III. The supraclavicular region is not included in this endpoint.
Measured: Up to 60 months
Number of Participants With Metastasis-free Survival
Measured by the time from date of enrollment to earlier of clinical detection of metastatic disease beyond the breast/chestwall and regional lymph nodes or death.
Measured: 12 months and 36 months
Number of Participants With Local-regional Failure Free Survival
Measured by the time from date of enrollment to earlier of clinical detection of any ipsilateral recurrent disease to the breast/chestwall or regional lymph nodes (levels I, II, III, supraclavicular, and internal mammary lymph nodes) or death.
Measured: 12 months and 36 months
Number of Participants With a Change in Quality of Life Score as Measured by the EORTC QLQ-C30
Patient's quality of life from pre-treatment to post-treatment, reported by the quality of life questionnaire [EORTC QLQ-C30 V1]. Summary scores and missing data handling were performed according to the EORTC QLQ-C30. The minimum score is 0, and the maximum score is 100. A higher score is a better outcome. A change in score is defined as a score increase of at least 10 points at the 12 month mark compared to baseline.
Measured: From baseline up to 12 months
Number of Participants With a Change in Quality of Life Score as Measured by the EORTC QLQ-BR23
Patient's quality of life from pre-treatment to post-treatment, reported by the quality of life questionnaire breast cancer module [EORTC QLQ-BR23 V1]. Summary scores and missing data handling were performed according to the EORTC QLQ-BR23. The minimum score is 0, and the maximum score is 100. A higher score is a better outcome. A change in score is defined as a score increase of at least 10 points from baseline.
Measured: Baseline to 1 year post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study start11 Aug 2016
- Primary completion13 Jun 2024
- Study completion13 Jun 2024
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.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Fisher, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700386
- Sponsor's protocol ID
- 15-1329.cc
- Status last verified
- Apr 2026
- First submitted
- 22 Feb 2016
- Last updated
- 30 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated, Comprehensive Radiation Therapy for Node-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT02700386
- Acronym / sponsor ID
- 15-1329.cc
- Conditions
- Breast Cancer
- Keywords
- Breast, Cancer, Hypofractionated, Node-Positive Breast Cancer, Radiation Therapy, Comprehensive Radiation Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Posted 20 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is being done to learn more about a particular dose of radiation treatment for breast cancer that is completed in a shorter amount of time than what has traditionally been used to treat breast cancer. Subjects are being asked to be in this research study because they have already had surgery for breast cancer and some cancer cells were found in their lymph nodes that drain the breast tissue.
Detailed description
Subjects who join the study will receive a shortened course of radiation treatment that will last approximately four (4) weeks, instead of the traditional six (6) week course that women have typically received in this situation. The shorter course subjects will receive is designed in a way that it is thought to be equivalent to the longer course. This shorter course has already been shown to be very safe and effective when treating breast cancer in the breast tissue only. However, because cancer cells were found in the lymph nodes that drain their breast, subjects require radiation to a larger area of their chest, armpit, and shoulder than has been completely tested with this experimental dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Hypofractionated Radiation | Experimental | Combination Product: Adjuvant Hypofractionated RadiationAdjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions. |
Who may qualify
- Ages
- 18 to 101 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult women (≥18 years old) with breast cancer who have undergone surgery for their primary breast tumor (either lumpectomy or mastectomy +/- reconstruction) and are confirmed to have involved lymph nodes on surgical pathology.
- Patient who have undergone either a total mastectomy or a lumpectomy are eligible.
- Acceptable procedures for assessment of axillary nodal status at the time of surgery include:
- Eligible women include AJCC (American Joint Committee on Cancer) 7th ed. Stage cN0 or cN1 subsequently staged after surgery as Stage pIB (N1mic), pIIA, pIIB, pIIIA, pIIIB, or N3a (10 or more axillary nodes) only: note that ypN0 will also be eligible if pathologic confirmation of nodal involvement was documented prior to neoadjuvant chemotherapy and the patient was found to be node-negative at the time of surgery. Note that women less than 50 years of age, women who received chemotherapy, patients staged as pN0 (i+ or mol+), and large-breasted women are eligible for enrollment.
- The patient must have recovered from surgery with the incision completely healed and no signs of infection. If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved. The patient must have an ECOG performance status of 0 or 1 (KPS >70%).
Key exclusion criteria (18 listed)
- patients <18 years old
- pregnant women
- male patients
- women with T4 disease, including inflammatory breast cancer
- women who have declined or otherwise not received preceding surgery
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 |
|---|---|---|
| Adjuvant Hypofractionated RadiationAlso: Radiation TherapyHypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy. | Combination product | Adjuvant Hypofractionated Radiation |
Primary outcome
Number of Participants With at Least One Treatment-related Adverse Event of Interest
Time frame: 12 months and 36 months
The composite endpoint is "yes" for a given patient if that patient experienced at least one of six component adverse events: lymphedema, shoulder ROM impairment, cardiac ischemia, symptomatic rib fracture, brachial plexopathy Grade 2 ('moderate symptoms; limiting instrumental activity of daily living (ADL)') or Grade 3 ('severe symptoms; limiting self-care ADL'), or Grade 2 pneumonitis (requires steroids). AEs were assessed by CTCAE version 4.03.
Number of Participants With Lymphedema Severity by Measuring Interlimb Circumference
Time frame: 12 months and 36 months
An increase in interlimb arm circumference of at least 10% in the lower arm or the upper arm, or both, compared with the contralateral arm at the same timepoint, will be judged to be clinically significant lymphedema. Arm circumference 15 cm above the medial epicondyle (upper arms) and 15 cm below the medial epicondyle (lower arms) will be assessed at 12 months and at 36 months.
Number of Participants With Symptomatic Rib Fracture as Measured by Plain Film or CT
Time frame: 12 months and 36 months
Symptomatic rib fracture will be diagnosed by evidence of a correlative lesion on plain film or CT.
Number of Participants With New Development of Ischemic Heart Disease as Measured by EKG
Time frame: 12 months and 36 months
Ischemic heart disease will be measured by the new development of angina with corresponding EKG changes, or myocardial infraction.
Number of Participants Reporting Shoulder Stiffness as Measured by the EORTC QLQ-BR23
Time frame: 12 months and 36 months
Shoulder stiffness severity is assessed using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire breast cancer module (EORTC QLQ-BR23). It is assessed based on patient response to the questionnaire item, "During the past week, was it difficult to raise your arm or to move it sideways?", which is scored from 1 to 4 with 1 being "not at all" and 4 being "very much". Shoulder stiffness is identified in a patient when their response to that question is 3 or 4 AND if their response increased numerically from their response on day 1.
Number of Participants With Grade 2 or Higher Pneumonitis
Time frame: 12 months and 36 months
Number of patients who experience pneumonitis as an adverse event at Grade 2 or higher as assessed by CTCAE v 4.03.
Number of Participants With Grade 2 or Higher Brachial Plexopathy
Time frame: 12 months and 36 months
Number of patients who experience brachial plexopathy as an adverse event at Grade 2 or higher as assessed by CTCAE v 4.03.
5 secondary outcomes
Number of Participants With Disease Recurrence
Time frame: Up to 60 months
Number of Participants With Metastasis-free Survival
Time frame: 12 months and 36 months
Number of Participants With Local-regional Failure Free Survival
Time frame: 12 months and 36 months
Number of Participants With a Change in Quality of Life Score as Measured by the EORTC QLQ-C30
Time frame: From baseline up to 12 months
Number of Participants With a Change in Quality of Life Score as Measured by the EORTC QLQ-BR23
Time frame: Baseline to 1 year post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Christine Fisher, MD, MPH principal investigator
University of Colorado, Denver
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adjuvant Hypofractionated Radiation in people with Breast Cancer, run by University of Colorado, Denver 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 11 inclusion and 18 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 30 Apr 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 20 Apr 2025). 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 at Least One Treatment-related Adverse Event of Interest (time frame: 12 months and 36 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.