Preoperative Radiation Schedules for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two different schedules of radiation therapy for breast cancer patients before surgery. One group receives the standard amount and number of radiation doses (preoperative radiation conventionally fractionated), while the other receives less radiation and fewer doses (preoperative radiation hypofractionated). The trial aims to determine which approach better manages the cancer and prepares for surgery. It may suit those with invasive breast cancer who have not yet undergone mastectomy and are planning tissue-based reconstruction. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
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 this trial's treatments are likely to be safe?
Research has shown that both preoperative radiation schedules for breast cancer are generally safe. For hypofractionated radiation (fewer, larger doses), studies indicate it is well-tolerated. Most patients experience few skin issues, and many have none at all. Over time, the cosmetic results are similar to those of conventional methods.
For conventionally fractionated radiation (more, smaller doses), research also shows a low rate of side effects. Studies find no major difference in complications between the two methods. Some studies even suggest that complications might be slightly lower with conventional radiation.
In summary, both radiation methods have proven safe with manageable side effects, making them well-tolerated options for patients considering this treatment.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these preoperative radiation schedules for breast cancer because they offer potential improvements over traditional post-surgery radiation. Unlike the standard of care, which typically involves multiple weeks of radiation after surgery, these treatments are administered before surgery, potentially reducing the overall treatment time. Group 1 uses a hypofractionated approach, which delivers higher doses in fewer sessions, possibly leading to quicker completion and less strain on patients. Meanwhile, Group 2 follows a conventionally fractionated schedule but still takes place pre-surgery, which could better target the cancer while it's still intact. These innovative approaches might enhance treatment efficiency and improve patient outcomes.
What evidence suggests that this trial's treatments could be effective for breast cancer?
This trial will compare two preoperative radiation schedules for breast cancer: hypofractionated and conventionally fractionated radiation therapies. Participants in Group 1 will receive hypofractionated radiation, which involves fewer treatment sessions with a higher dose each time. Studies have found this approach effectively controls cancer, with a 98.7% success rate in preventing cancer from returning to the treated area within 3 years, while also shortening treatment time and reducing side effects.
Participants in Group 2 will receive conventionally fractionated radiation, which involves more sessions with lower doses each time. Research has linked this approach to better survival rates specific to breast cancer and a lower chance of the cancer returning in the same area. Both treatments manage breast cancer effectively, though they differ in side effects and convenience.12467Who Is on the Research Team?
Benjamin D. Smith, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with invasive breast cancer who plan to have tissue-based reconstruction after mastectomy. It's open to those with certain advanced stages of cancer, including T3-T4c or N1-N3 and even stage T4d in specific cases. Patients must not have had previous radiation in the affected area, be pregnant, or have recurrent breast cancer or active scleroderma.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Radiation
Participants receive either hypofractionated or conventionally fractionated preoperative radiation therapy
Surgery
Participants undergo mastectomy with immediate autologous breast reconstruction
Follow-up
Participants are monitored for safety and effectiveness after treatment, including evaluation of oncologic and surgical outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Group 1 (preoperative radiation hypofractionated)
- Group 2 (preoperative radiation conventionally fractionated)
Group 1 (preoperative radiation hypofractionated) is already approved in United States, European Union, Canada for the following indications:
- Breast cancer
- Breast cancer
- Breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Artidis
Collaborator
Artidis
Industry Sponsor