Reirradiation for Breast Cancer

(REPEAT Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Dartmouth-Hitchcock Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a reirradiation treatment called accelerated partial breast irradiation (aPBI) for individuals with breast cancer that has returned in the same breast after previous treatment. The main goal is to determine if the side effects of this reirradiation are manageable and if it effectively controls the cancer locally. The trial will also assess the breast's appearance after treatment. Suitable candidates for this trial include those with a second breast cancer in the same breast, diagnosed over a year after their initial breast-conserving therapy, and who have previously received radiation treatment. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that aPBI re-irradiation is likely to be safe?

Research has shown that Accelerated Partial Breast Irradiation (aPBI) re-irradiation is generally well-tolerated by patients. A review of studies found that this treatment has manageable side effects, which are not severe for most people. One study found that the chance of breast cancer recurrence after aPBI is low, with only 3.3% of patients experiencing a recurrence over ten years. This suggests that the treatment is both effective and relatively safe.

Additionally, earlier research has demonstrated that re-irradiation is safe and feasible for women who have already undergone breast-conserving therapy. Patients who have had prior radiation can often safely receive it again, with acceptable side effects. These findings provide reassurance for those considering joining a clinical trial involving aPBI re-irradiation.12345

Why are researchers excited about this trial's treatment?

Reirradiation for breast cancer is unique because it offers a new approach for patients who experience a recurrence of breast cancer in the same breast after previously undergoing breast-conserving therapy. While standard treatments typically involve surgery, chemotherapy, or hormone therapy, this method focuses on delivering precise radiation to the affected area again. Researchers are excited about this treatment because it has the potential to effectively target and reduce cancer cells in the breast while minimizing damage to surrounding healthy tissue. This could offer a promising alternative for patients looking to avoid more invasive procedures.

What evidence suggests that aPBI re-irradiation might be an effective treatment for breast cancer?

Studies have shown that aPBI (accelerated partial breast irradiation) re-irradiation, which participants in this trial will receive, can help prevent breast cancer recurrence. In one study, only 5% of patients experienced a return of cancer within 5 years, indicating that most did not face recurrence during that period. Another study found that 92% of patients remained cancer-free after re-irradiation, with only one patient experiencing a recurrence. Additionally, data from a 10-year follow-up revealed a low recurrence rate of just 3.3% after aPBI treatment. These results suggest that aPBI re-irradiation is promising for preventing cancer from returning in the treated breast area.25678

Are You a Good Fit for This Trial?

This trial is for people with breast cancer who need a second round of radiation treatment to the breast (re-irradiation). Specific inclusion and exclusion criteria are not listed, but generally participants would be those whose doctors think re-irradiation could help.

Inclusion Criteria

Patients who are able to provide informed consent
I am not pregnant or breastfeeding and will use birth control during radiation therapy.
I still have the breast affected by cancer.
See 6 more

Exclusion Criteria

I do not want to take part in this study.
Patients who do not meet ASTRO 2023 guidelines for a strong recommendation for partial breast irradiation including conditionally recommended, conditionally not recommended, and not recommended categories
Patients who are pregnant
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive breast re-irradiation with aPBI to assess treatment-associated adverse events and local control

Up to 1 year

Follow-up

Participants are monitored for safety, effectiveness, and cosmetic outcomes after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • aPBI Re-irradiation

Trial Overview

The study is testing whether giving partial-breast irradiation again (aPBI re-irradiation) after previous radiation is safe and effective. Researchers will look at side effects, cancer control in the treated area, and cosmetic results.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: aPBI Re-irradiationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials
548
Recruited
2,545,000+

Citations

Partial Breast Reirradiation for Patients With Ipsilateral ...

This prospective study assessed the feasibility and efficacy of using APBI in patients who had prior whole breast irradiation.

Partial Breast Reirradiation for Breast Cancer Recurrences ...

The oncological outcome after repeat BCS followed by postoperative re-RT achieved promising results: the 5-year local recurrences rate was reported to be 5% [21] ...

Partial Breast Reirradiation for Patients With Ipsilateral ...

Median follow-up after retreatment was 7.8 years. One patient in the IORT group had a subsequent tumor bed recurrence, yielding a local control of 92%. One ...

A systematic review of the different re-irradiation techniques

The aim of this review was to describe and report the oncological outcome and toxicity profile of the different re-irradiation techniques currently available/ ...

Partial Breast Irradiation Is Effective in Preventing ...

Ten-year follow-up data presented at SABCS showed that 3.3% of patients experienced breast cancer recurrence after APBI compared with 2.6% who ...

Different Re-Irradiation Techniques after Breast-Conserving ...

STRO study reported a second local recurrence rate of 7% at 10 years. At a median follow-up of 5.5 years, four patients had breast cancer ...

Repeat lumpectomy as an alternative to salvage mastectomy

However, data over the past decade have demonstrated the safety and feasibility of reirradiation as part of repeat breast conservation as well as locoregional ...

Partial Breast Reirradiation for Breast Cancer Recurrences ...

However, nodal-negative women have a 10-year risk for local recurrences after RT of up to 15.6% [4], with most local recurrences occurring in the proximity of ...