897 Participants Needed

Hypofractionated Radiation Therapy for Breast Cancer

Recruiting at 863 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Alliance for Clinical Trials in Oncology
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
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.

Do I need to stop 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.

What data supports the effectiveness of the treatment Hypofractionated Radiation Therapy for Breast Cancer?

Research shows that hypofractionated radiation therapy (HFRT) is as effective and safe as traditional radiation therapy for early breast cancer, with fewer treatment sessions needed. Studies also indicate that HFRT is being increasingly used in real-world settings for both early and locally advanced breast cancer, suggesting its growing acceptance and effectiveness.12345

Is hypofractionated radiation therapy safe for breast cancer patients?

Research shows that hypofractionated radiation therapy (HFRT) is generally safe for breast cancer patients, with studies indicating it has similar safety levels to traditional radiation treatments. Some concerns about local control and toxicity exist, but overall, HFRT is becoming a standard treatment due to its safety and effectiveness.12456

How is hypofractionated radiation therapy different from other treatments for breast cancer?

Hypofractionated radiation therapy (HFRT) is unique because it delivers higher doses of radiation over fewer sessions compared to conventional radiation therapy, making the treatment period shorter. This approach is becoming a standard for breast cancer treatment due to its effectiveness and convenience.12367

Research Team

MP

Matthew Poppe, MD

Principal Investigator

Huntsman Cancer Hospital, University of Utah

Eligibility Criteria

This trial is for women with stage IIa-IIIa breast cancer who've had a mastectomy. They must not be pregnant, have no history of certain other cancers or severe diseases, and agree to birth control if of childbearing potential. Participants should not have received prior chest radiation and must plan to start treatment within specific timeframes.

Inclusion Criteria

I haven't had radiation therapy to my chest, neck, or armpit area; but I may have had radioactive iodine treatment.
My mastectomy showed no cancer cells at the edges of the removed tissue.
I have never had invasive breast cancer in my other breast.
See 21 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Patients undergo radiation therapy daily on Monday-Friday for 5-6 weeks

5-6 weeks

Hypofractionated Radiation Therapy

Patients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4 weeks

3-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

  • Hypofractionated Radiation Therapy
Trial Overview The study tests hypofractionated radiation therapy, which uses higher doses over a shorter period than traditional radiation, after mastectomy to prevent cancer recurrence. It includes lab biomarker analysis and quality-of-life assessments.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (hypofractionated radiation therapy)Experimental Treatment4 Interventions
Patients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4 weeks.
Group II: Group I (radiation therapy)Active Control4 Interventions
Patients undergo radiation therapy daily on Monday-Friday for 5-6 weeks.

Hypofractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Hypofractionated Radiotherapy for:
  • Soft tissue sarcoma
  • Extremity soft tissue sarcoma
🇪🇺
Approved in European Union as Hypofractionated Radiotherapy for:
  • Soft tissue sarcoma
  • Extremity soft tissue sarcoma
🇨🇦
Approved in Canada as Hypofractionated Radiotherapy for:
  • Soft tissue sarcoma
  • Extremity soft tissue sarcoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials
521
Recruited
224,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Canadian Cancer Trials Group

Collaborator

Trials
135
Recruited
70,300+

Findings from Research

In a study of 1,010 breast cancer patients, hypofractionated radiotherapy (HFRT) showed similar locoregional recurrence-free survival (LRRFS) and disease-free survival (DFS) rates compared to conventionally fractionated radiotherapy (CFRT) after a median follow-up of 49.5 months.
While HFRT was effective across various nodal stages and molecular subtypes, it tended to show lower DFS in N2-3 patients with triple-negative breast cancer compared to CFRT, indicating a need for further investigation in this specific group.
Real-World Practice of Hypofractionated Radiotherapy in Patients With Invasive Breast Cancer.Chen, F., Hui, TSK., Ma, L., et al.[2022]
In a study of 56 breast cancer patients receiving hypofractionated external beam radiotherapy (HFRT) after mastectomy, the treatment was well tolerated with mild to moderate acute skin toxicity, and no severe hematological toxicity was observed, indicating a favorable safety profile.
HFRT effectively delivered targeted doses to the chest wall while minimizing exposure to surrounding organs, with mean lung and heart doses remaining within safe limits, suggesting that HFRT can be a viable option for post-mastectomy radiotherapy.
A Study on Dosimetric Outcomes and Acute Toxicity of Post Mastectomy Adjuvant Hypofractionated Radiotherapy for Breast Cancer.Deshmukh, S., Sharan, K., Fernandes, DJ., et al.[2022]
In a study of 463 breast cancer patients, hypofractionated radiotherapy (HFRT) showed a similar rate of locoregional recurrence compared to conventional fractionated radiotherapy (CFRT), with 2.7% recurrence in HFRT versus 4.3% in CFRT.
The 4-year local recurrence-free survival rates were also comparable, with 97% for HFRT and 95% for CFRT, indicating that HFRT is a safe and effective alternative for treating locally advanced breast cancer.
Comparative retrospective analysis of locoregional recurrence in unselected breast cancer patients treated with conventional versus hypofractionated radiotherapy at a tertiary cancer center?Yadav, R., Lal, P., Agarwal, S., et al.[2022]

References

Real-World Practice of Hypofractionated Radiotherapy in Patients With Invasive Breast Cancer. [2022]
A Study on Dosimetric Outcomes and Acute Toxicity of Post Mastectomy Adjuvant Hypofractionated Radiotherapy for Breast Cancer. [2022]
Comparative retrospective analysis of locoregional recurrence in unselected breast cancer patients treated with conventional versus hypofractionated radiotherapy at a tertiary cancer center? [2022]
Hypofractionated Radiation Therapy (HFRT) of Breast/Chest Wall and Regional Nodes in Locally Advanced Breast Cancer: Toxicity Profile and Survival Outcomes in Retrospective Monoistitutional Study. [2022]
Hypofractionated radiation treatment in early breast cancer: Results in a New Zealand setting. [2018]
Assessment of toxicities and outcomes in patients with breast cancer treated with hypofractionated radiotherapy. [2022]
Emerging Role of Hypofractionated Radiotherapy with Simultaneous Integrated Boost in Modern Radiotherapy of Breast Cancer. [2020]
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