Hypofractionated Radiotherapy for Breast Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Severe illnesses, Uncontrolled illness, Lupus, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 16

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores hypofractionated radiotherapy for individuals with non-metastatic breast cancer. The goal is to determine if administering larger doses of radiation less frequently, either before or after surgery, is effective and safe. The trial compares two approaches: one group receives radiation before surgery, and the other after surgery. Individuals diagnosed with breast cancer that hasn't spread and are scheduled for radiation therapy might be suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in breast cancer treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hypofractionated radiation therapy is generally easy for patients to handle. One study found that more than half of the patients did not experience skin problems, meaning their skin was not badly affected. In simpler terms, most people did not have severe skin issues from the treatment. Another study found few short-term side effects, indicating low rates of acute toxicity. This treatment also seems to cause fewer changes in the appearance of the breast, suggesting good cosmetic results.

Overall, these findings suggest that hypofractionated radiation therapy is safe, with minimal side effects for many patients. However, each person's experience can differ. Patients should always discuss potential risks and benefits with their healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for breast cancer?

Researchers are excited about hypofractionated radiotherapy for breast cancer because it offers a more convenient and potentially less burdensome treatment schedule compared to traditional radiotherapy. Unlike conventional radiation therapy, which often requires daily sessions over several weeks, hypofractionated radiotherapy delivers higher doses in just five sessions. This not only shortens the treatment time but may also improve patient comfort and adherence. Additionally, by integrating this approach with standard chemotherapy and surgery, there is potential to maintain or even enhance the effectiveness of cancer treatment with fewer side effects.

What evidence suggests that hypofractionated radiotherapy could be an effective treatment for non-metastatic breast cancer?

Research has shown that hypofractionated radiation therapy effectively treats breast cancer. Studies have found that it offers survival rates similar to traditional radiation methods, with fewer side effects. In one study, patients demonstrated excellent survival rates and reported that the treated area maintained a good appearance. This therapy uses larger doses over fewer sessions, making treatment more convenient.

In this trial, participants in Arm I will receive preoperative hypofractionated radiation therapy followed by surgery. Early findings suggest this approach might further reduce side effects by treating the breast tissue while it's still intact. Participants in Arm II will undergo surgery followed by postoperative hypofractionated radiation therapy. Overall, hypofractionated radiation therapy presents a promising option for breast cancer treatment. ^{1 3 4 6 7}

Who Is on the Research Team?

Carlos E. Vargas, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with non-metastatic breast cancer, meaning their cancer hasn't spread from the original site. It's exploring if giving radiation in larger doses over a shorter period before or after breast surgery can be effective and safe.

Inclusion Criteria

Able to and provides Institutional Review Board (IRB)-approved study specific written informed consent

Able to complete all mandatory tests listed in the trial

Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Exclusion Criteria

Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

I have active systemic lupus or scleroderma.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants undergo standard of care chemotherapy

Varies based on SOC regimen

Radiotherapy

Participants receive hypofractionated radiotherapy once daily for a total of 5 fractions

1 week

Surgery

Participants undergo standard of care breast surgery

10 weeks after radiation treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Follow-up visits at 16 weeks, 6 months, 12 months, 24 months, 36 months, 48 months, and 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation Therapy

Trial Overview The study is testing hypofractionated radiotherapy, which involves fewer but larger doses of radiation, either before (preoperative) or after (postoperative) breast surgery. The goal is to see if this approach reduces treatment time and side effects while being an effective treatment for various types of breast cancer.

How Is the Trial Designed?

Group I: Arm II (Surgery + postoperative radiation therapy) Experimental Treatment 12 Interventions

Patients undergo SOC chemotherapy and SOC breast surgery followed by breast hypofractionated radiotherapy QD for a total of 5 fractions. Patients also undergo CT, MRI, PET, CEDM, and/or breast US throughout the study. Additionally, patients undergo a breast biopsy and may undergo optional blood sample collection and tissue collection on study.

Group II: Arm I (Preoperative radiation therapy + surgery) Experimental Treatment 12 Interventions

Patients undergo SOC chemotherapy followed by breast hypofractionated radiotherapy QD for a total of 5 fractions. Patients then undergo SOC breast surgery 10 weeks after radiation treatment. Patients also undergo CT, MRI, PET, CEDM, and/or breast US throughout the study. Additionally, patients undergo a breast biopsy and may undergo optional blood sample collection and tissue collection on study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

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 2309 breast cancer patients, those receiving hypofractionated radiotherapy experienced significantly less acute skin reactions and pain compared to those receiving conventional fractionation, indicating a safer treatment option.

Hypofractionation also resulted in lower levels of patient-reported symptoms like burning, swelling, and fatigue during treatment, suggesting it may enhance patient comfort without compromising long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in the Acute Toxic Effects of Breast Radiotherapy by Fractionation Schedule: Comparative Analysis of Physician-Assessed and Patient-Reported Outcomes in a Large Multicenter Cohort. Jagsi, R., Griffith, KA., Boike, TP., 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]

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]

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 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]

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 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]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa0906260

Long-Term Results of Hypofractionated Radiation Therapy ... At 10 years, 71.3% of women in the control group as compared with 69.8% of the women in the hypofractionated-radiation group had a good or excellent cosmetic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10845660/

Efficacy and safety analysis of hypofractionated and ... In this meta-analysis, we conducted a comparative analysis of the safety and efficacy of hypofractionated and conventional fractionated ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0960977625006526

Once-Weekly Ultra-Hypofractionated Radiation Therapy for ... This study reports outcomes of once-weekly adjuvant whole-breast radiotherapy in elderly and/or comorbid patients with breast cancer, including ...

4. ascopubs.org ascopubs.org/doi/10.1200/GO-24-00277

Phase II Evaluation of Ultra-Hypofractionated ... The study found that ultra-hypofractionated radiation therapy in patients with breast cancer had low rates of acute toxicity and cosmesis changes.

5. clinical-breast-cancer.com clinical-breast-cancer.com/article/S1526-8209(21)00266-4/fulltext

Hypofractionated Radiation Therapy (HFRT) of ... HFRT showed excellent survival outcomes comparable to conventional fractionation. HFRT had excellent toxicity profile, with no acute nor late toxicities ≥G3.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820925002344

Real World Safety of Adjuvant Ultra Hypofractionated ... Ultra-hypofractionated breast radiotherapy (26 Gy in 5 fractions) was well tolerated. · More than half of patients showed no skin toxicity; grade ...

7. thegreenjournal.com thegreenjournal.com/article/S0167-8140(25)00144-6/abstract

First results of the UNICANCER HypoG-01 phase III trial Early toxicity of moderately hypofractionated radiation therapy in breast cancer patients receiving locoregional irradiation: First results of the UNICANCER ...