Breast CancerNCT06664892
Ultrahypofractionated Whole Breast Radiation Following Chemotherapy
A study testing Ultra-hypofractionated radiation in people with Breast Cancer, run by MetroHealth Medical Center.
Trial summary
This is a single institution, non-randomized, non-inferiority study comparing prospectively collected data for acute and late effects on the breast associated with ultrahypofractionated whole breast radiation (WBI) following breast conserving surgery (BCS) and chemotherapy to historical controls for breast cancer (BC)… Read more about this study
- Who is it for?
- Ages 60 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ultra-hypofractionated radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged at least 60 years with invasive BC (T1-3) with clinically or pathologically negative axillary nodes following BCS who have a high-risk Mammaprint or Oncotype testing and receive chemotherapy. (If no axillary surgery planned, patients must have pre-operative negative axillary ultrasound)
- Invasive ductal, lobular, medullary, papillary, colloid (mucinous), or tubular histologies are allowed
- Any receptor status is allowed (ER/PR/Her2-neu)
- Patients with negative resection margins defined as 2 mm from ink, or a negative re-excision
- Bilateral BC is allowed, provided each cancer meets inclusion criteria
- Nodal RT is not allowed
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- There must be no concern for distant metastatic disease
- Neoadjuvant or adjuvant chemotherapy is permitted provided pretreatment clinical and radiographic staging meets inclusion criteria. Specific adjuvant/neoadjuvant therapies are at the discretion of the treating Medical Oncologist. There are no systemic therapies that are not allowed on this study.
- Patients must be deemed fit to receive the prescribed systemic therapy
- Immunotherapy is allowed
- Targeted Her-2 neu therapy, including concurrent therapy is allowed
- Other targeted therapies are allowed (including but not limited to CDK inhibitors)
- Endocrine therapy, including concurrent therapy is allowed
- Participation in other non-RT clinical trial is allowed
- Must be able to sign informed consent
Who cannot join
- Patients with stage IV BC
- Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible)
- Prior thoracic or breast RT
- The following RT methods and techniques are not permitted:
- Brachytherapy or intraoperative RT (IORT)
- Proton therapy
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- Regional nodal RT
- Tumor bed boost
- Patients who have breast reconstruction with implant or expander
- Patients who have had a mastectomy for current BC
- Patients requiring a tumor bed boost
- Palpable or radiographic suspicious or contralateral lymph nodes or N2 disease
- Paget's disease of the nipple.
- Non-epithelial breast malignancies such as sarcoma or lymphoma
- History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry
- Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma
- Pregnancy or lactation at the time of study entry/ or intention to become pregnant during treatment.
- Patients with serious medical illness or psychiatric illness that would interfere with the trial.
- Patients with active infection in the radiation treatment portal.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrahypofractionated Whole Breast Radiation Following Breast Conserving Surgery and Chemotherapy in Patients > 60 Years of Age With Clinically Low-Risk, Node-Negative Breast Cancer Who Have Received Prior Chemotherapy
This is a single institution, non-randomized, non-inferiority study comparing prospectively collected data for acute and late effects on the breast associated with ultrahypofractionated whole breast radiation (WBI) following breast conserving surgery (BCS) and chemotherapy to historical controls for breast cancer (BC) patients who receive hypofractionated RT following BCS and chemotherapy.
Read the detailed description
Standard treatment approaches for patients with localized BC includes BCS followed WBI [1], which has demonstrated equivalent local control and survival when compared to mastectomy [2,3]. Although conventionally fractionated radiotherapy (RT) (50 Gy 2 Gy per fraction) administered in 25 fractions in 5 weeks was historically used, moderate hypofractionation RT trials utilizing shorter treatment times and higher doses per session have resulted in favorable outcomes [4,5,6]. In addition, increased local control and reduced toxicity rates observed in moderate hypofractionation RT trials [5,6] have resulted in studies evaluating the use of ultrahypofractionated breast RT which further shorten the treatment time. The results of the FAST-Forward RT trial have shown that adjuvant RT using 26 Gy/5.2 Gy per fraction, over 5 fractions administered in 1 week, was not inferior to the standard 40.05 Gy/15 fx/3 weeks for local tumor control and is equally safe in terms of effects on normal tissue [7]. Side effects associated with RT can be more pronounced in patients when RT is combined with surgery and/or chemotherapy [9]. There are abundant data describing the safety of combining conventionally fractionated RT following chemotherapy. Similarly, there are several trials which have reported outcomes of patients who have received hypofractionated RT, including subsets of patients who also received chemotherapy demonstrating similar acute and late toxicity profiles compared to standard fractionation regimens [10, 11, 12, 13]. Although the FAST-Forward trial included patients who received neoadjuvant and adjuvant chemotherapy and estimates of 5-year cumulative incidence of any moderate or marked clinician-assessed normal tissue effects in the breast or chest wall were reported to be similar for 40 Gy 15 fraction hypofractionated vs the 26 Gy 5 fraction ultrahypofractionated RT regimen (26·8% v 28·5%, respectively), the study was not designed to detect differences for those who had received prior chemotherapy compared to those who did not [7]. Retrospective subgroup analysis did not identify differences in adverse effects related to prior chemotherapy, however confidence intervals overlapped, and the power for these retrospective subgroup analyses was low [19]. Hence, there is limited data evaluating the toxicity of ultrahypofractionated adjuvant breast RT in patients who have received prior chemotherapy. This study is designed to evaluate the acute and late effects on the breast of ultrahypofractionated WBI using the FAST-forward regimen (26 Gy, 5.2 Gy per fraction delivered in 1 week) in patients > 60 years of age with pathologically or clinically node-negative early-stage BC who undergo BCS and chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Ultra-hypofractionated radiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-hypofractionated radiationRadiation
RT, delivered via external beam, 5.2 Gy per fraction for 5 fractions following BCS and neoadjuvant or adjuvant chemotherapy. Specific adjuvant/neoadjuvant therapies are at the discretion of the treating Medical Oncologist.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Radiation: Ultra-hypofractionated radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary(1)
Incidence of acute toxicities during and up to 3 months following completion of RT in BC patients who receive ultrahypofractionated WBI in BC patients who have received prior chemotherapy compared to historic controls for BC patients who have received prior chemotherapy and hypofractionated RT
Measured: up to 3 months
Primary (2)
Incidence of late toxicities of the breast up to 2 years following completion of RT in BC patients who receive ultrahypofractionated WBI in BC patients who have received prior chemotherapy compared to historic controls for BC patients who have received prior chemotherapy and hypofractionated RT
Measured: Up to 2 years
Secondary outcomes (2)
Secondary (1)
Incidence of acute toxicities during and up to 3 months following completion of RT for BC patients who received neoadjuvant chemotherapy vs adjuvant chemotherapy
Measured: Up to 3 months
Secondary (2)
Incidence of late toxicities of the breast up to 2 years following completion of RT in BC patients who received neoadjuvant chemotherapy vs adjuvant chemotherapy
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Apr 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Russo, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664892
- Sponsor's protocol ID
- MHCI 24-01
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrahypofractionated Whole Breast Radiation Following Breast Conserving Surgery and Chemotherapy in Patients > 60 Years of Age With Clinically Low-Risk, Node-Negative Breast Cancer Who Have Received Prior Chemotherapy
- ClinicalTrials.gov ID
- NCT06664892
- Acronym / sponsor ID
- MHCI 24-01
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single institution, non-randomized, non-inferiority study comparing prospectively collected data for acute and late effects on the breast associated with ultrahypofractionated whole breast radiation (WBI) following breast conserving surgery (BCS) and chemotherapy to historical controls for breast cancer (BC) patients who receive hypofractionated RT following BCS and chemotherapy.
Detailed description
Standard treatment approaches for patients with localized BC includes BCS followed WBI [1], which has demonstrated equivalent local control and survival when compared to mastectomy [2,3]. Although conventionally fractionated radiotherapy (RT) (50 Gy 2 Gy per fraction) administered in 25 fractions in 5 weeks was historically used, moderate hypofractionation RT trials utilizing shorter treatment times and higher doses per session have resulted in favorable outcomes [4,5,6]. In addition, increased local control and reduced toxicity rates observed in moderate hypofractionation RT trials [5,6] have resulted in studies evaluating the use of ultrahypofractionated breast RT which further shorten the treatment time. The results of the FAST-Forward RT trial have shown that adjuvant RT using 26 Gy/5.2 Gy per fraction, over 5 fractions administered in 1 week, was not inferior to the standard 40.05 Gy/15 fx/3 weeks for local tumor control and is equally safe in terms of effects on normal tissue [7]. Side effects associated with RT can be more pronounced in patients when RT is combined with surgery and/or chemotherapy [9]. There are abundant data describing the safety of combining conventionally fractionated RT following chemotherapy. Similarly, there are several trials which have reported outcomes of patients who have received hypofractionated RT, including subsets of patients who also received chemotherapy demonstrating similar acute and late toxicity profiles compared to standard fractionation regimens [10, 11, 12, 13]. Although the FAST-Forward trial included patients who received neoadjuvant and adjuvant chemotherapy and estimates of 5-year cumulative incidence of any moderate or marked clinician-assessed normal tissue effects in the breast or chest wall were reported to be similar for 40 Gy 15 fraction hypofractionated vs the 26 Gy 5 fraction ultrahypofractionated RT regimen (26·8% v 28·5%, respectively), the study was not designed to detect differences for those who had received prior chemotherapy compared to those who did not [7]. Retrospective subgroup analysis did not identify differences in adverse effects related to prior chemotherapy, however confidence intervals overlapped, and the power for these retrospective subgroup analyses was low [19]. Hence, there is limited data evaluating the toxicity of ultrahypofractionated adjuvant breast RT in patients who have received prior chemotherapy. This study is designed to evaluate the acute and late effects on the breast of ultrahypofractionated WBI using the FAST-forward regimen (26 Gy, 5.2 Gy per fraction delivered in 1 week) in patients > 60 years of age with pathologically or clinically node-negative early-stage BC who undergo BCS and chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Radiation: Ultra-hypofractionated radiation |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients aged at least 60 years with invasive BC (T1-3) with clinically or pathologically negative axillary nodes following BCS who have a high-risk Mammaprint or Oncotype testing and receive chemotherapy. (If no axillary surgery planned, patients must have pre-operative negative axillary ultrasound)
- Invasive ductal, lobular, medullary, papillary, colloid (mucinous), or tubular histologies are allowed
- Any receptor status is allowed (ER/PR/Her2-neu)
- Patients with negative resection margins defined as 2 mm from ink, or a negative re-excision
- Bilateral BC is allowed, provided each cancer meets inclusion criteria
Key exclusion criteria (19 listed)
- Patients with stage IV BC
- Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible)
- Prior thoracic or breast RT
- The following RT methods and techniques are not permitted:
- Patients who have breast reconstruction with implant or expander
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 |
|---|---|---|
| Ultra-hypofractionated radiationRT, delivered via external beam, 5.2 Gy per fraction for 5 fractions following BCS and neoadjuvant or adjuvant chemotherapy. Specific adjuvant/neoadjuvant therapies are at the discretion of the treating Medical Oncologist. | Radiation | Treatment Arm |
Primary outcome
Primary(1)
Time frame: up to 3 months
Incidence of acute toxicities during and up to 3 months following completion of RT in BC patients who receive ultrahypofractionated WBI in BC patients who have received prior chemotherapy compared to historic controls for BC patients who have received prior chemotherapy and hypofractionated RT
Primary (2)
Time frame: Up to 2 years
Incidence of late toxicities of the breast up to 2 years following completion of RT in BC patients who receive ultrahypofractionated WBI in BC patients who have received prior chemotherapy compared to historic controls for BC patients who have received prior chemotherapy and hypofractionated RT
2 secondary outcomes
Secondary (1)
Time frame: Up to 3 months
Secondary (2)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- 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.
Suzanne Russo, MD principal investigator
MetroHealth Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-hypofractionated radiation in people with Breast Cancer, run by MetroHealth Medical Center.
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 15 inclusion and 19 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: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Koretia Williams, MBA (216-778-5470, kwilliams7@metrohealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary(1) (time frame: up to 3 months). The study lists 2 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 14 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.