Radiotherapy Omission for Early Breast Cancer
(PROSPECTIVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if some individuals with early-stage breast cancer can skip radiotherapy after surgery without increasing the risk of cancer recurrence. The study uses MRI results to identify those who might safely avoid radiotherapy. It includes two groups: those eligible for radiotherapy omission and those receiving standard treatment. Ideal candidates for this trial are women with ER-positive or HER2-positive breast cancer in one breast, whose MRI results suggest they can safely skip radiotherapy.
As an unphased trial, this study offers participants the chance to contribute to research that could potentially reduce the future need for radiotherapy.
What prior data suggests that this protocol is safe for early breast cancer patients?
Research has shown that skipping radiotherapy can be safe for some patients with early-stage breast cancer. One study found that patients with low-risk, early-stage breast cancer who did not undergo radiotherapy had similar recurrence rates and survival rates as those who received the treatment. Another study found that while omitting radiotherapy might slightly increase the risk of local recurrence, it does not affect overall survival. These findings suggest that for patients with favorable MRI results, skipping radiotherapy can be a safe option.12345
Why are researchers excited about this trial?
Most treatments for early breast cancer involve surgery followed by radiotherapy to reduce the risk of recurrence. However, the new approach of radiotherapy omission is gaining attention because it might allow some patients to skip radiation altogether, especially those with a low-risk profile based on specific MRI and pathology findings. Researchers are excited about this treatment because it could spare patients from the side effects and time commitment of radiotherapy while still effectively managing the cancer. This approach could lead to a more personalized treatment plan, focusing on what each patient truly needs based on their risk factors.
What evidence suggests that radiotherapy omission might be an effective treatment for early breast cancer?
This trial will compare the outcomes of omitting radiotherapy with standard treatment for early-stage breast cancer. Research has shown that skipping radiotherapy after surgery for early-stage breast cancer might not significantly increase the risk of recurrence. Studies have found that patients with low-risk, early-stage breast cancer had similar recurrence rates and survival rates, regardless of radiotherapy. Specifically, one study found a 10-year survival rate of 83.1%, with very few deaths directly from breast cancer. Additionally, omitting radiotherapy can improve quality of life, enhancing physical function and appearance. However, some studies noted a slight increase in local recurrence, though it did not affect the spread to other parts of the body.12367
Who Is on the Research Team?
Steven David, MD
Principal Investigator
Peter MacCallum Cancer Centre - Moorrabin
Alastair Thompson, MD
Principal Investigator
Baylor College of Medicine
Bruce Mann, MD
Principal Investigator
Melbourne Health
Are You a Good Fit for This Trial?
This trial is for women over 50 with early-stage, ER-positive and/or HER2-positive breast cancer that appears to be localized in one breast. They must be healthy enough for a 10-year follow-up, agree to surgery within 8 weeks of MRI or registration, and comply with systemic treatment if they have Grade 3 or HER2-positive cancer.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative MRI Assessment
Participants undergo pre-operative MRI to assess parenchymal enhancement and determine eligibility for radiotherapy omission
Surgery
Participants undergo breast-conserving surgery
Follow-up
Participants are monitored for safety and effectiveness after surgery, with assessments of recurrence rates and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Radiotherapy Omission
Trial Overview
The PROSPECTIVE trial is testing whether MRI results can identify patients who may safely skip radiotherapy after surgery without increasing the risk of breast cancer recurrence. It compares standard post-operative radiotherapy (Arm B) against omitting it (Arm A).
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants with nil, minimal or mild parenchymal enhancement on pre-operative MRI whose pathology meets inclusion/exclusion requirements for omission of post-operative radiotherapy will be allocated to Arm A, unless the participant prefers to receive Standard Treatment (Arm B) or following clinical team recommendation. Arm A participants will be divided into 2 groups: * Arm A1: Grade 1 or 2/HER2 negative ("low risk") * Arm A2: Grade 3 and/or HER2 positive ("high risk")
Participants who are found to be ineligible for RT omission on study; includes management of MRI-detected lesions. Participants with any of: * Moderate or marked parenchymal enhancement on pre-operative MRI * A malignant occult lesion identified on MRI; or * Pathology that does not meet inclusion/exclusion criteria will receive standard multidisciplinary team recommendations to guide treatment. Participants may also be included in Arm B due to their own preference or following clinical team recommendation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Breast Cancer Trials, Australia and New Zealand
Lead Sponsor
Citations
Breast-Conserving Surgery with or without Irradiation in ...
Omission of radiotherapy was associated with an increased incidence of local recurrence but had no detrimental effect on distant recurrence as the first event ...
Re-Evaluating the Omission of Radiation Therapy in Low ...
The purpose of this review is to evaluate the data evaluating omission of RT for early-stage breast cancer following BCS, review ongoing studies ...
Radiotherapy omission in low-risk, early-stage breast cancer
Low-risk, early-stage breast cancer patients exhibited comparable disease recurrence and survival rates regardless of the RT status. Our study underscores the ...
JNCI: Journal of the National Cancer Institute | Oxford Academic
The overall survival rate at 10 years was 83.1% (95% CI = 80.8% to 85.4%). In total, 3 (0.5%) patients died because of breast cancer. Conclusion. Our results ...
Quality of Life Outcomes Associated With Optimization ...
Omission of RT was associated with better QoL and functional and cosmetic outcomes. It was highly acceptable to patients.
Adjuvant Radiation and Endocrine Therapy in Early-Stage ...
Findings In this cohort study of 2249 patients aged 50 to 69 years with early-stage, hormone receptor–positive breast cancer and an Oncotype DX ...
Safety Analysis of Omitting Radiotherapy After Breast ...
Omitting radiotherapy after breast-conserving surgery increases local recurrence risk without compromising overall survival in early-stage ...
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