Breast Cancer RecurrentPhase 1/2REPEATNCT07612254
aPBI Re-irradiation
A Phase 1/2 study testing Reirradiation in people with Breast Cancer Recurrent, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This study is to determine whether acute treatment-associated adverse events following breast re-irradiation with aPBI are acceptably low and to assess local control following breast re-irradiation with aPBI. An exploratory aim is to assess cosmetic outcomes following breast re-irradiation with aPBI. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Breast Cancer Recurrent
- What is being tested?
- Reirradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2026to Apr 2033
- Phase
- Phase 1/2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have histologically-confirmed, second, ipsilateral breast cancer which was diagnosed more than one year after completing breast conserving therapy.
- Patients must have received prior radiotherapy to the breast
- Patients must have an intact, involved breast.
- Patients must meet ASTRO 2023 guidelines for a strong recommendation for partial breast irradiation.
- Grade 1-2 disease
- ER-positive histology
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- Tumor size up to 2 cm
- Patient's age 40 or older
- Patients who will undergo breast radiation therapy at D-H Lebanon, D-H St. Johnsbury, or Cheshire Medical Center.
- Patients must have a lumpectomy cavity that can be delineated on CT scan.
- Patients who are able to provide informed consent.
- Females of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry.
- Females of childbearing potential must not be pregnant and not lactating and willing to use medically acceptable form of contraception during radiation therapy.
Who cannot join
- Patients who meet any of the criteria below may NOT participate in this study:
- Patients who have not received prior radiotherapy to the ipsilateral breast.
- Patients who do not meet ASTRO 2023 guidelines for a strong recommendation for partial breast irradiation, including those who meet criteria for conditionally recommended, conditionally not recommended, and not recommended for partial breast irradiation.
- Patients who are < 40 years of age.
- Patients with breast implants or other breast reconstruction.
- Patients who received a prior course of aPBI or breast brachytherapy in the ipsilateral breast.
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- Patients who are actively receiving treatment or within 1 year of treatment from another malignancy, excluding non-melanoma skin cancers.
- Patients who are pregnant.
- Patients who are unable to provide informed consent.
- Patients who decline participation in the study.
- Patients with active systemic lupus erythematosus, or any history of scleroderma, dermatomyositis with active rash are excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: REPEAT: RE-irradiation With a Partial brEast, Accelerated Technique: A Single-Center, Multi-site, Prospective, Phase I/II Clinical Trial
This study is to determine whether acute treatment-associated adverse events following breast re-irradiation with aPBI are acceptably low and to assess local control following breast re-irradiation with aPBI. An exploratory aim is to assess cosmetic outcomes following breast re-irradiation with aPBI.
- Conditions
- Breast Cancer Recurrent
- Being tested
- Reirradiation
- Keywords
- Ipsilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReirradiationRadiation
aPBI, which is routinely used to treat patients who have previously not been irradiated, with a dose of 30 Gy in 5 fractions using a VMAT technique.
| Study group | Role | What they receive |
|---|---|---|
| aPBI Re-irradiation | Experimental | Patients who have histologically-confirmed, second, ipsilateral breast cancer which was diagnosed more than one year after completing breast conserving therapy and have received or are receiving re-irradiation for in-breast recurrence of breast cancer. Receives: Radiation: Reirradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-associated toxicity
Acceptably low acute treatment-associated adverse events following breast re-irradiation with aPBI.
Measured: Within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start3 Jun 2026 (estimated)
- Primary completion28 Apr 2032 (estimated)
- Study completionApr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm, phase I/II clinical trial. The study will be conducted in two stages. We plan to enroll the first 11 participants into the phase 1 portion of the trial and follow them for toxicities for 1 year. Once toxicity assessment is complete and safety is determined, an additional 22 participants
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lesley A. Jarvis, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612254
- Sponsor's protocol ID
- Study02002817
- Other IDs
- 25JAR817
- Acronym
- REPEAT
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REPEAT: RE-irradiation With a Partial brEast, Accelerated Technique: A Single-Center, Multi-site, Prospective, Phase I/II Clinical Trial
- ClinicalTrials.gov ID
- NCT07612254
- Acronym / sponsor ID
- REPEAT / Study02002817
- Conditions
- Breast Cancer Recurrent
- Keywords
- Ipsilateral
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 3 Jun 2026 (estimated)
- Primary completion
- 28 Apr 2032 (estimated)
- Study completion
- Apr 2033 (estimated)
- First posted
- 28 May 2026 (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 study is to determine whether acute treatment-associated adverse events following breast re-irradiation with aPBI are acceptably low and to assess local control following breast re-irradiation with aPBI. An exploratory aim is to assess cosmetic outcomes following breast re-irradiation with aPBI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm, phase I/II clinical trial. The study will be conducted in two stages. We plan to enroll the first 11 participants into the phase 1 portion of the trial and follow them for toxicities for 1 year. Once toxicity assessment is complete and safety is determined, an additional 22 participants
| Arm | Type | Receives |
|---|---|---|
| aPBI Re-irradiation | Experimental | Radiation: ReirradiationPatients who have histologically-confirmed, second, ipsilateral breast cancer which was diagnosed more than one year after completing breast conserving therapy and have received or are receiving re-irradiation for in-breast recurrence of breast cancer. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients who have histologically-confirmed, second, ipsilateral breast cancer which was diagnosed more than one year after completing breast conserving therapy.
- Patients must have received prior radiotherapy to the breast
- Patients must have an intact, involved breast.
- Patients must meet ASTRO 2023 guidelines for a strong recommendation for partial breast irradiation.
- Patients who will undergo breast radiation therapy at D-H Lebanon, D-H St. Johnsbury, or Cheshire Medical Center.
Key exclusion criteria (11 listed)
- Patients who have not received prior radiotherapy to the ipsilateral breast.
- Patients who do not meet ASTRO 2023 guidelines for a strong recommendation for partial breast irradiation, including those who meet criteria for conditionally recommended, conditionally not recommended, and not recommended for partial breast irradiation.
- Patients who are < 40 years of age.
- Patients with breast implants or other breast reconstruction.
- Patients who received a prior course of aPBI or breast brachytherapy in the ipsilateral breast.
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 |
|---|---|---|
| ReirradiationaPBI, which is routinely used to treat patients who have previously not been irradiated, with a dose of 30 Gy in 5 fractions using a VMAT technique. | Radiation | aPBI Re-irradiation |
Primary outcome
Treatment-associated toxicity
Time frame: Within 1 year
Acceptably low acute treatment-associated adverse events following breast re-irradiation with aPBI.
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 28 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Reirradiation in people with Breast Cancer Recurrent, run by Dartmouth-Hitchcock Medical Center at 1 site 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 13 inclusion and 11 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 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Treatment-associated toxicity (time frame: Within 1 year). 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 28 May 2026.