126 Participants Needed

Preoperative Radiation Schedules for Breast Cancer

BD
Overseen ByBenjamin D. Smith, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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.12467

Who Is on the Research Team?

BD

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

After chemotherapy, my ultrasound showed improvement in my breast and nearby lymph nodes without any suspicious nodes in the chest area.
I plan to have breast reconstruction using my own tissue.
My breast cancer is HER2 positive and I've had chemotherapy before surgery.
See 6 more

Exclusion Criteria

Patients who are pregnant
I have active scleroderma.
I have had radiation therapy on my breast, lower neck, or chest area.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Radiation

Participants receive either hypofractionated or conventionally fractionated preoperative radiation therapy

6-8 weeks

Surgery

Participants undergo mastectomy with immediate autologous breast reconstruction

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of oncologic and surgical outcomes

18 months

What Are the Treatments Tested in This Trial?

Interventions

  • Group 1 (preoperative radiation hypofractionated)
  • Group 2 (preoperative radiation conventionally fractionated)
Trial Overview The TOPAz trial compares two preoperative radiation schedules before breast surgery: a hypofractionated course (less radiation in fewer doses) versus a conventionally fractionated one (standard amount and number of doses). The goal is to see which method works better for patients undergoing mastectomy followed by immediate autologous reconstruction.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Group 2 (preoperative radiation conventionally fractionated)Experimental Treatment2 Interventions
Group II: Group 1 (preoperative radiation hypofractionated)Experimental Treatment2 Interventions

Group 1 (preoperative radiation hypofractionated) is already approved in United States, European Union, Canada for the following indications:

πŸ‡ΊπŸ‡Έ
Approved in United States as Hypofractionated Radiation Therapy for:
πŸ‡ͺπŸ‡Ί
Approved in European Union as Hypofractionated Radiation Therapy for:
πŸ‡¨πŸ‡¦
Approved in Canada as Hypofractionated Radiation Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Artidis

Collaborator

Trials
1
Recruited
130+

Artidis

Industry Sponsor

Trials
5
Recruited
600+

Published Research Related to This Trial

Recent advancements in radiation therapy for non-metastatic breast cancer, particularly hypofractionation and partial breast irradiation, have led to optimized treatment approaches that consider both patient and tumor characteristics.
Despite strong level-1 evidence supporting hypofractionation, its adoption in routine practice has been slow, prompting the AIRO Breast Cancer Group to issue position statements aimed at standardizing postoperative radiation therapy practices based on current evidence.
The Italian Association for Radiotherapy and Clinical Oncology (AIRO) position statements for postoperative breast cancer radiation therapy volume, dose, and fractionation.Meattini, I., Palumbo, I., Becherini, C., et al.[2023]
Hypofractionated radiation therapy is an effective treatment option for selected early breast cancer patients after breast-conserving surgery, allowing for higher doses in fewer sessions.
The optimal timing, fractionation, and total dose for delivering the tumor bed boost in hypofractionated schedules are still being researched, indicating a need for further studies to refine treatment protocols.
Tumor Bed Boost Integration during Whole Breast Radiotherapy: A Review of the Current Evidence.Franco, P., Cante, D., Sciacero, P., et al.[2020]
Randomized trials indicate that hypofractionation using 2.67 Gy fractions for adjuvant whole breast radiotherapy does not compromise local tumor control or increase late adverse effects, suggesting it is a safe treatment option.
There is potential for even fewer larger fractions to be safely administered, but ongoing research is needed to determine the effectiveness and safety of a 5-fraction schedule, especially considering the volume of breast tissue treated.
Pushing the limits of hypofractionation for adjuvant whole breast radiotherapy.Yarnold, J., Haviland, J.[2018]

Citations

Efficacy and safety analysis of hypofractionated and ...Adjuvant radiation for breast cancer patients is associated with improved cancer-specific survival and a decreased chance of locoregional ...
Hypofractionated vs Conventionally Fractionated ...This randomized clinical trial compares the outcomes of hypofractionation vs conventional fractionation postmastectomy radiation therapy ...
Hypofractionation Radiotherapy vs. Conventional ...The UK Standardization Breast Radiotherapy START Trial A and B found that breast appearance and breast hardness were the most common changes among the two ...
Hypofractionation vs Conventional Fractionation in Patients ...Complication rates at 2 years after breast reconstructive surgery were 14% with hypofractionated radiation and 12% with conventional radiation, ...
Randomised controlled trials on radiation dose ...MHF shows improved safety profile, cosmesis, and quality of life compared with CF while maintaining equivalent oncological outcomes.
A Meta-Analysis of Randomized Controlled TrialsOur results suggest that there is no statistical difference between HFRT and CFRT in terms of LR, RFS, OS, and cosmetic outcomes.
NCT05774678 | Trial Of PreoperAtive Radiation (TOPAz ...To compare the outcomes of and responses to 2 different radiation therapy schedules (the standard radiation amount and number of doses versus less radiation and ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of ServiceΒ·Privacy PolicyΒ·CookiesΒ·Security