Breast CancerPhase 2NCT06129747
Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast
A Phase 2 study testing Radiation Therapy in people with Breast Cancer and Tumor, Breast, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
The standard treatment for participants whose cancer has returned after breast conserving surgery is radiation given twice daily (separated by at least 6 hours) for a total of 30 treatments. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Breast Cancer, Tumor, Breast
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2023to 9 Aug 2029
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), tubular or mixed histologies. Three years of time must have elapsed since the end of the last course of whole breast irradiation.
- Lesion size < 3 cm treated with a partial mastectomy. Participants with invasive cancer and clinically and radiographically negative axillas do not require an axillary lymph node sampling unless they did not have prior axillary lymph node sampling (e.g. previous cancer was DCIS). Participants with DCIS as their recurrence do not require surgical assessment of the axilla. Repeat sentinel lymph node biopsy is permitted.
- Negative resection margins with at least no tumor on ink or a negative re-excision.
- Participants with invasive recurrence must have a negative re-staging work-up consisting of either a CT chest/abdomen and a bone scan or a PET scan.
- Hormonal therapy is allowed. If chemotherapy is planned, it can be delivered either prior to or after the radiation is delivered. There must be at least 2 weeks between radiation and chemotherapy. HER2 directed therapy can be delivered concurrently with radiation.
- Participants must be > 18 years of age. Because no dosing or adverse event data are currently available on the use of breast re-irradiation in participants ≤18 years of age, children are excluded from this study.
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- Participants must have the ability to understand and the willingness to sign a written informed consent document.
- Performance status: ECOG Performance status ≤ 2.
- Life expectancy of ≥ 12months, in the opinion of and as documented by the investigator.
- Not based on gender; this trial is open to any gender, defined as self-representation of gender identity.
Who cannot join
- Participants with nodal or distant metastatic disease < 3 years since prior radiation.
- Participants with invasive pure lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or uncontrolled nonepithelial breast malignancies such as lymphoma or sarcoma.
- Participants with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.
- Participants with Paget's disease of the nipple.
- Participants with skin involvement.
- Participants with scleroderma or dermatomyositis.
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- Participants with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.
- Participants who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.
- Participants with known BRCA 1/BRCA 2 mutations.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
- Recruiting
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
Rahul Tendulkar, MD, 866-223-8100, TaussigResearch@ccf.org
Rahul Tendulkar, MD
About this study
Official title: Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation for Participants With Ipsilateral Breast Tumor Recurrence Treated Initially With Breast Conserving Surgery and Whole Breast Radiation Therapy
The standard treatment for participants whose cancer has returned after breast conserving surgery is radiation given twice daily (separated by at least 6 hours) for a total of 30 treatments. The purpose of this study is to find out if giving radiation once a day for 15 treatments after repeat breast conserving surgery works as well as giving it the standard way.
Read the detailed description
Breast cancer survival rates have greatly improved with advances in both screening and treatment. The standard of care for both early stage and selected locally advanced breast cancers is breast conserving therapy (BCT), consisting of a partial mastectomy followed by radiation treatment. Traditionally, a salvage mastectomy was the standard treatment for women who initially underwent BCT and experienced an ipsilateral breast tumor recurrence (IBTR). Many participants have become increasingly motivated to avoid mastectomy, and there has been rising interest in repeat BCS (Breast Conserving Surgery) with focal radiation for certain participants motivated to keep their breast. The current standard of care for breast re-irradiation after an in-breast tumor recurrence is partial breast irradiation consisting of a dose of 45 Gy delivered BID for 30 fractions. While this regimen demonstrated excellent local control and low AEs, the regimen itself is difficult for participants. Receiving RT twice daily at smaller doses per fraction (1.5 Gy) for 30 treatments can be burdensome, especially for those without reliable transportation or difficulty getting time away from work. Given the excellent local control rates and low rate of AEs, in this study, we hypothesize that daily hypofractionated EBRT(External Beam Radiation Therapy) for re-irradiation after repeat BCS would be at least as well tolerated with good local control and provide a more convenient option for participants than the current standard of care established by RTOG 1014. Some participants will present with high-risk features (e.g. age <50, high grade, ER negative tumors, close margins) making dose escalation an attractive option to improve local control. Options for dose escalation include sequential and concurrent administration of a boost.
- Conditions
- Breast Cancer, Tumor, Breast
- Being tested
- Radiation Therapy
- Keywords
- Radiation Therapy, In-Breast Recurrence, Tumor, Re-irradiation
- 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.
Radiation TherapyRadiation
Weeks 1, 2 and 3
- Weeks 1, 2 and 3 will include 5 days of treatment.
- One radiation treatment to breast on each of the 5 days. Each radiation treatment session will last a 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy(RT) | Experimental | There will be one treatment cohort. Radiation therapy will be delivered daily for 15 daily fractions, 2.67Gy per fraction, delivered using a 3-D or IMRT(Intensity Modulate Radiation Therapy) plan. For participants with high-risk features deemed by the radiation oncologist who would otherwise be a candidate for a boost (age <50, high grade, poor biology, close margins), 48 Gy delivered in fifteen fractions of 3.2 Gy is allowed. Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related adverse events as graded by CTCAE criteria
Rate of grade 3+ treatment-related skin, fibrosis, and breast pain adverse events occurring within 1 year from the completion of re-irradiation as graded by CTCAE criteria.
Measured: 1 year from the completion of re-irradiation
Secondary outcomes (16)
In-breast tumor recurrence rate
The overall in-breast tumor recurrence rate will be estimated using the cumulative incidence function.
Measured: 3 years
In-breast tumor recurrence rate
The overall in-breast tumor recurrence rate is estimated using the cumulative incidence function.
Measured: 5 years
In-breast tumor recurrence rate
The overall in-breast tumor recurrence rate will be estimated using the cumulative incidence function.
Measured: 10 years
Rate of freedom from mastectomy
The freedom from mastectomy rate will be estimated using the cumulative incidence function.
Measured: 3 years
Rate of freedom from mastectomy
The freedom from mastectomy rate will be estimated using the cumulative incidence function.
Measured: 5 years
Rate of freedom from mastectomy
The freedom from mastectomy rate will be estimated using the cumulative incidence function.
Measured: 10 years
Treatment-related adverse events
All treatment-related adverse events for the defined time periods
Measured: 1 year from completion of re-irradiation
Treatment-related adverse events
All treatment-related adverse events for the defined time periods
Measured: Overall for 3 years from completion of re-irradiation
Evaluation of Cosmesis
Determined by an established Global Cosmesis Score grading from 1 through 4, with 1 being excellent and 4 being rated as poor
Measured: 1 year
Evaluation of Cosmesis
Determined by an established Global Cosmesis Score grading from 1 through 4, with 1 being excellent and 4 being rated as poor
Measured: 3 years
Overall survival rate
Overall survival will be estimated using Kaplan-Meier Method
Measured: 3 years
Overall survival rate
Overall survival will be estimated using Kaplan-Meier Method
Measured: 5 years
Overall survival rate
Overall survival will be estimated using Kaplan-Meier Method
Measured: 10 years
Mastectomy-free survival rate
Mastectomy-free survival will be estimated using Kaplan-Meier Method
Measured: 3 years
Mastectomy-free survival rate
Mastectomy-free survival will be estimated using Kaplan-Meier Method
Measured: 5 years
Mastectomy-free survival rate
Mastectomy-free survival will be estimated using Kaplan-Meier Method
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start30 Nov 2023
- Primary completion9 Aug 2029 (estimated)
- Study completion9 Aug 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.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Model description
- Participants will receive once daily radiation for 15 fractions to 40.05 Gy total dose. Participants with high risk features (high grade disease, young age, close margins (\<2mm), triple negative subtype, HER2 positive tumors not receiving HER2 targeted systemic therapy) may receive a simultaneous boost to 48 Gy in 15 fractions.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janice Lyons, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterRahul Tendulkar, MD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129747
- Sponsor's protocol ID
- CASE4123
- Status last verified
- Aug 2026
- First submitted
- 8 Nov 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be used for study purposes only and not otherwise shared
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation for Participants With Ipsilateral Breast Tumor Recurrence Treated Initially With Breast Conserving Surgery and Whole Breast Radiation Therapy
- ClinicalTrials.gov ID
- NCT06129747
- Acronym / sponsor ID
- CASE4123
- Conditions
- Breast Cancer, Tumor, Breast
- Keywords
- Radiation Therapy, In-Breast Recurrence, Tumor, Re-irradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 9 Aug 2029 (estimated)
- Study completion
- 9 Aug 2029 (estimated)
- First posted
- 13 Nov 2023 (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.
The standard treatment for participants whose cancer has returned after breast conserving surgery is radiation given twice daily (separated by at least 6 hours) for a total of 30 treatments. The purpose of this study is to find out if giving radiation once a day for 15 treatments after repeat breast conserving surgery works as well as giving it the standard way.
Detailed description
Breast cancer survival rates have greatly improved with advances in both screening and treatment. The standard of care for both early stage and selected locally advanced breast cancers is breast conserving therapy (BCT), consisting of a partial mastectomy followed by radiation treatment. Traditionally, a salvage mastectomy was the standard treatment for women who initially underwent BCT and experienced an ipsilateral breast tumor recurrence (IBTR). Many participants have become increasingly motivated to avoid mastectomy, and there has been rising interest in repeat BCS (Breast Conserving Surgery) with focal radiation for certain participants motivated to keep their breast. The current standard of care for breast re-irradiation after an in-breast tumor recurrence is partial breast irradiation consisting of a dose of 45 Gy delivered BID for 30 fractions. While this regimen demonstrated excellent local control and low AEs, the regimen itself is difficult for participants. Receiving RT twice daily at smaller doses per fraction (1.5 Gy) for 30 treatments can be burdensome, especially for those without reliable transportation or difficulty getting time away from work. Given the excellent local control rates and low rate of AEs, in this study, we hypothesize that daily hypofractionated EBRT(External Beam Radiation Therapy) for re-irradiation after repeat BCS would be at least as well tolerated with good local control and provide a more convenient option for participants than the current standard of care established by RTOG 1014. Some participants will present with high-risk features (e.g. age <50, high grade, ER negative tumors, close margins) making dose escalation an attractive option to improve local control. Options for dose escalation include sequential and concurrent administration of a boost.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will receive once daily radiation for 15 fractions to 40.05 Gy total dose. Participants with high risk features (high grade disease, young age, close margins (<2mm), triple negative subtype, HER2 positive tumors not receiving HER2 targeted systemic therapy) may receive a simultaneous boost to 48 Gy in 15 fractions.
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy(RT) | Experimental | Radiation: Radiation TherapyThere will be one treatment cohort. Radiation therapy will be delivered daily for 15 daily fractions, 2.67Gy per fraction, delivered using a 3-D or IMRT(Intensity Modulate Radiation Therapy) plan. For participants with high-risk features deemed by the radiation oncologist who would otherwise be a candidate for a boost (age <50, high grade, poor biology, close margins), 48 Gy delivered in fifteen fractions of 3.2 Gy is allowed. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), tubular or mixed histologies. Three years of time must have elapsed since the end of the last course of whole breast irradiation.
- Lesion size < 3 cm treated with a partial mastectomy. Participants with invasive cancer and clinically and radiographically negative axillas do not require an axillary lymph node sampling unless they did not have prior axillary lymph node sampling (e.g. previous cancer was DCIS). Participants with DCIS as their recurrence do not require surgical assessment of the axilla. Repeat sentinel lymph node biopsy is permitted.
- Negative resection margins with at least no tumor on ink or a negative re-excision.
- Participants with invasive recurrence must have a negative re-staging work-up consisting of either a CT chest/abdomen and a bone scan or a PET scan.
- Hormonal therapy is allowed. If chemotherapy is planned, it can be delivered either prior to or after the radiation is delivered. There must be at least 2 weeks between radiation and chemotherapy. HER2 directed therapy can be delivered concurrently with radiation.
Key exclusion criteria (9 listed)
- Participants with nodal or distant metastatic disease < 3 years since prior radiation.
- Participants with invasive pure lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or uncontrolled nonepithelial breast malignancies such as lymphoma or sarcoma.
- Participants with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.
- Participants with Paget's disease of the nipple.
- Participants with skin involvement.
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 |
|---|---|---|
| Radiation TherapyWeeks 1, 2 and 3 * Weeks 1, 2 and 3 will include 5 days of treatment. * One radiation treatment to breast on each of the 5 days. Each radiation treatment session will last a 30 minutes. | Radiation | Radiation Therapy(RT) |
Primary outcome
Treatment-related adverse events as graded by CTCAE criteria
Time frame: 1 year from the completion of re-irradiation
Rate of grade 3+ treatment-related skin, fibrosis, and breast pain adverse events occurring within 1 year from the completion of re-irradiation as graded by CTCAE criteria.
16 secondary outcomes
In-breast tumor recurrence rate
Time frame: 3 years
In-breast tumor recurrence rate
Time frame: 5 years
In-breast tumor recurrence rate
Time frame: 10 years
Rate of freedom from mastectomy
Time frame: 3 years
Rate of freedom from mastectomy
Time frame: 5 years
Rate of freedom from mastectomy
Time frame: 10 years
Treatment-related adverse events
Time frame: 1 year from completion of re-irradiation
Treatment-related adverse events
Time frame: Overall for 3 years from completion of re-irradiation
Evaluation of Cosmesis
Time frame: 1 year
Evaluation of Cosmesis
Time frame: 3 years
Overall survival rate
Time frame: 3 years
Overall survival rate
Time frame: 5 years
Overall survival rate
Time frame: 10 years
Mastectomy-free survival rate
Time frame: 3 years
Mastectomy-free survival rate
Time frame: 5 years
Mastectomy-free survival rate
Time frame: 10 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 6 Aug 2026.
- Individual participant dataSharing planned: No. Data will be used for study purposes only and not otherwise shared
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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.
Janice Lyons, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Rahul Tendulkar, MD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
2 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 Radiation Therapy in people with Breast Cancer and Tumor, Breast, run by Case Comprehensive Cancer Center at 2 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 10 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 Janice Lyons, MD ((216) 844-2514, Janice.lyons@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related adverse events as graded by CTCAE criteria (time frame: 1 year from the completion of re-irradiation). 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 6 Aug 2026.