Omitting Radiation Therapy for Breast Cancer
(ROSALIE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether women with certain types of breast cancer can safely skip radiation therapy after a lumpectomy. Researchers aim to determine if reducing the treatment burden is possible without compromising the effectiveness of cancer care. Eligible participants have a new diagnosis of breast cancer that hasn't spread to the lymph nodes, have completed at least 8 weeks of chemotherapy, and have no remaining cancer after surgery. The study seeks to determine if omitting radiation could be a safe option for these patients. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in cancer care.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients with hormone receptor-positive disease should have endocrine therapy planned, and those with Her2+ disease should receive targeted therapy. It's best to discuss your specific medications with the trial team.
What prior data suggests that this protocol is safe for de-escalating radiation therapy in women with breast cancer?
Research shows that skipping radiation therapy can be safe for some breast cancer patients. Studies have found that women aged 65 and older with low-risk, early-stage breast cancer did not experience worse survival rates without radiation. For these women, the cancer did not spread to other parts of the body.
However, some evidence suggests that omitting radiation might slightly increase the chance of the cancer returning in the same area of the breast. This risk should be weighed against the possible side effects of radiation therapy.
Overall, not having radiation appears well-tolerated and does not lead to worse outcomes for certain groups of patients. Consulting with a healthcare provider is essential to determine the best approach for individual health needs.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the potential of omitting radiation therapy for patients with clinically node-negative breast cancer who undergo lumpectomy. Typically, radiation therapy is a standard part of post-surgery treatment to reduce the risk of cancer recurrence. However, skipping radiation could mean fewer side effects and a quicker recovery for patients. This approach could simplify treatment plans and improve the quality of life for those who qualify, making it a significant area of interest for researchers.
What evidence suggests that omitting radiation therapy could be effective for breast cancer?
Research shows that skipping radiation therapy in breast cancer treatment can increase the chance of the cancer returning in the same area. However, it does not seem to affect the cancer spreading to other parts of the body. Studies have found that omitting radiation might lead to worse outcomes, particularly with the cancer recurring in the breast. Despite this, the overall survival rate remains very high, with more than 99% of patients surviving breast cancer for at least 10 years. This suggests that while the risk of local recurrence increases, it may not significantly impact overall survival, especially for patients at low risk.12678
Who Is on the Research Team?
Thierry Muanza, MD
Principal Investigator
Jewish General Hospital
Mark Basik, MD
Principal Investigator
Jewish General Hospital
Elena Parvez, MD
Principal Investigator
Juravinski Cancer Centre
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemotherapy
Participants receive neoadjuvant chemotherapy prior to surgery
Surgery
Participants undergo breast conserving surgery and axillary staging surgery
Follow-up
Participants are monitored for local, regional, and distant recurrence, as well as overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Radiation Omission
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ontario Clinical Oncology Group (OCOG)
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 ...
Omitting radiotherapy in elderly breast cancer patients
The data shows that without radiotherapy, there is a higher risk of local breast cancer recurrence over the long term even if it may not necessarily impact ...
Re-Evaluating the Omission of Radiation Therapy in Low ...
Together, these original studies demonstrated clearly that the omission of RT was associated with inferior outcomes. We highlight preliminary ...
Adjuvant Radiation and Endocrine Therapy in Early-Stage ...
This cohort study of US patients with breast cancer examines the association of de-escalating adjuvant therapies with locoregional ...
Can Radiation Therapy Be Omitted in Low-Risk Breast ...
Of the 95 patients who died during 10-year follow-up, 3 died due to breast cancer; the overall breast cancer–specific survival rate was >99%.
Re-Evaluating the Omission of Radiation Therapy in Low ...
Together, these original studies demonstrated clearly that the omission of RT was associated with inferior outcomes. We highlight preliminary studies first ...
JNCI: Journal of the National Cancer Institute | Oxford Academic
Omitting radiotherapy in women ≥65 years with low-risk early breast cancer after breast-conserving surgery and adjuvant endocrine therapy is safe. Eur J Surg ...
Omitting Radiation Therapy After Breast-Conserving ...
“We found that omitting postoperative radiation therapy did not compromise survival or increase the risk of distant metastasis,” said Kunkler.
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