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

Disqualifiers: Metaplastic breast cancer, T4, N3, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

897 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

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. ^{1 2 3 6 7}

Research Team

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.

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

Group I: Group II (hypofractionated radiation therapy) Experimental Treatment 4 Interventions

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

Group II: Group I (radiation therapy) Active Control 4 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Hypofractionated radiation therapy (HFRT) for locally advanced breast cancer showed excellent overall survival rates of 100% at 1 year and 90% at 3 years, indicating its efficacy as a treatment option.

The treatment had a low toxicity profile, with only 1.6% of patients experiencing local recurrence and manageable rates of skin toxicity and lymphedema, suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. De Matteis, S., Facondo, G., Valeriani, M., et al.[2022]

In a study of 274 early breast cancer patients treated with hypofractionated radiation treatment (HFRT) over a median follow-up of 7 years, the local recurrence-free survival rate was very high at 97.2%, indicating that HFRT is effective in preventing local cancer recurrence.

The acute toxicity associated with HFRT was generally low, with most patients experiencing less than grade 3 side effects, suggesting that HFRT is a safe treatment option for eligible patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation treatment in early breast cancer: Results in a New Zealand setting. James, ML., Dehn, G., Robinson, BA.[2018]

In a study of 81 patients with localized breast cancer treated with hypofractionated radiotherapy (HFRT), the treatment was well-tolerated, with low rates of late toxicities such as chest pain (11%) and limb pain (12%).

The five-year overall survival rate was 76.5%, and there were no locoregional recurrences, indicating that HFRT is effective in controlling the disease while minimizing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of toxicities and outcomes in patients with breast cancer treated with hypofractionated radiotherapy. Sindhu, M., Malik, M., Ahmed, SF., et al.[2022]

Hypofractionated radiotherapy is gaining importance in breast cancer treatment, suggesting a shift towards more efficient radiation delivery methods.

The introduction of simultaneous integrated boost techniques allows for targeted treatment of the primary tumor region, potentially improving treatment outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging Role of Hypofractionated Radiotherapy with Simultaneous Integrated Boost in Modern Radiotherapy of Breast Cancer. Nitsche, M., Dunst, J., Carl, UM., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Real-World Practice of Hypofractionated Radiotherapy in Patients With Invasive Breast Cancer. [2022]

2. India pubmed.ncbi.nlm.nih.gov

A Study on Dosimetric Outcomes and Acute Toxicity of Post Mastectomy Adjuvant Hypofractionated Radiotherapy for Breast Cancer. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Comparative retrospective analysis of locoregional recurrence in unselected breast cancer patients treated with conventional versus hypofractionated radiotherapy at a tertiary cancer center? [2022]

4. United States pubmed.ncbi.nlm.nih.gov

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]

5. Australia pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation treatment in early breast cancer: Results in a New Zealand setting. [2018]

6. India pubmed.ncbi.nlm.nih.gov

Assessment of toxicities and outcomes in patients with breast cancer treated with hypofractionated radiotherapy. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Emerging Role of Hypofractionated Radiotherapy with Simultaneous Integrated Boost in Modern Radiotherapy of Breast Cancer. [2020]