Pre-Surgery Radiation Boost for Breast Cancer

Not currently recruiting at 10 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rutgers, The State University of New Jersey
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 explores a new approach to treating breast cancer that hasn't spread. Researchers aim to determine if a radiation boost—extra focused radiation—before surgery can target the tumor more precisely and spare healthy tissue, potentially improving cosmetic results and tumor control. This trial is for individuals with biopsy-confirmed breast cancer, no signs of cancer in nearby lymph nodes, and no existing metastatic disease. Participants must be able to safely undergo radiation and surgery.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future breast cancer treatments.

Do I need to stop taking my current medications for this trial?

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 to get a clear answer.

What prior data suggests that this radiation boost is safe for breast cancer patients?

Research has shown that using extra radiation before breast surgery has been safe in past studies. Results indicate that serious wound problems are rare and similar to those with regular treatment methods. This suggests that additional radiation does not significantly increase serious side effects compared to standard care. Overall, the treatment is considered safe for patients, with manageable side effects.12345

Why are researchers excited about this trial?

Researchers are excited about this pre-surgery radiation boost for breast cancer because it offers a new timing strategy for using radiation. Unlike standard radiation treatments that typically occur after surgery, this approach delivers a concentrated dose of radiation before surgery. This could potentially shrink tumors more effectively before they are surgically removed, which might lead to better outcomes for patients. Additionally, this method could reduce the need for more extensive surgery, potentially sparing more healthy tissue and improving recovery times.

What evidence suggests that this radiation boost is effective for breast cancer?

This trial will evaluate the effects of a radiation boost before surgery for breast cancer. Studies have shown that this approach might help target the breast tumor more precisely. It could shrink the tumor and limit the exposure of healthy tissue to radiation. Research indicates that patients receiving this pre-surgery radiation boost have low cancer recurrence rates and experience manageable side effects. Additionally, a shorter course of radiation has proven to be as effective and safe as the standard course for early-stage breast cancer. These findings suggest that a radiation boost before surgery could improve tumor control and cosmetic results without increasing risks.26789

Who Is on the Research Team?

BG

Bruce G Haffty

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

This trial is for individuals with non-metastatic breast cancer, who are in good physical condition (ECOG 0-1), and have no signs of cancer spread. Pregnant women must test negative for pregnancy. Participants should be willing to follow the study protocol and haven't had prior chest radiation or chemotherapy.

Inclusion Criteria

You can participate if you have cancer in both sides of your body at the same time.
Willingness to participate in the clinical trial and adhere to the study protocol
Individuals of all races, genders and ethnic groups are eligible for this trial
See 5 more

Exclusion Criteria

You require chemotherapy before surgery.
You have received radiation therapy on the same side of your body as the breast or chest area.
You have inflammatory breast cancer at an advanced stage.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy Boost

Participants undergo radiation therapy boost over 4 fractions prior to surgery

1-2 weeks

Surgery

Participants undergo standard of care surgery 1-3 weeks from the last day of boost

1-3 weeks

Whole Breast Irradiation (WBI)

Participants continue standard of care WBI 3 to 5 weeks after surgery

3-5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
Follow-up visits at 1, 3, 6, 9, 12, 18, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Radiation Boost

Trial Overview

The trial studies the safety of a 'boost' dose of radiation given before surgery to target tumors more precisely, potentially improving cosmetic outcomes and tumor control. It includes quality-of-life assessments and MRI scans as part of evaluating this approach.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment (radiation therapy boost, WBI)Experimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Preoperative Radiation Boost Results in Low Rates of Re ...

A radiation tumor bed boost is delivered after BCS and WBRT by convention and due to limited historic data demonstrating significant toxicities ...

Shorter Radiation Course for Some with Early Breast Cancer

A condensed course of radiation was as effective and safe as the standard course for women with higher-risk early-stage breast cancer who ...

Breast-Conserving Surgery with or without Irradiation in ...

Overall survival at 10 years was almost identical in the two groups, at 80.8% (95% CI, 77.2 to 84.3) with no radiotherapy and 80.7% (95% CI, ...

Radiation Therapy Boost Before Surgery for the Treatment ...

This phase II trial investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast ...

First Results of the Primary Outcome of a Phase 2 ...

This prospective phase 2 study assessed the feasibility of delivering the RT boost before surgery. We hypothesize wound complication rates to be comparable ...

NCT04871516 | Radiation Therapy Boost Before Surgery ...

This phase II trial investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast ...

Study Explores Pre-Operative Radiation Boost for Breast ...

The primary outcome of the study was to demonstrate that the incidence of grade 3 or more wound complications is not inferior to the current ...

Radiation Therapy Boost before Surgery for the Treatment ...

This phase II trial investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast cancer

First Results of the Primary Outcome of a Phase 2 ...

The use of a preoperative RT boost followed by whole breast RT as administered here resulted in an acceptable primary outcome with a similar ...