Shorter Course Radiation for Breast Cancer

Not currently recruiting at 2 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Disqualifiers: Pregnancy, Male, T4 disease, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 3-4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a shorter course of radiation treatment for women who have had breast cancer surgery and found cancer cells in their lymph nodes. The goal is to determine if this quicker treatment, known as adjuvant hypofractionated radiation, matches the effectiveness of traditional, longer radiation courses. Participants will receive a condensed radiation regimen over 3-4 weeks. Ideal candidates are women who have undergone breast cancer surgery, had cancer cells in their lymph nodes, and have fully recovered from surgery.

As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important advancements in breast cancer care.

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 study team or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that adjuvant hypofractionated radiation, a type of radiation treatment given after surgery, is usually well-tolerated by patients. In studies, most patients did not experience serious skin problems. More than half had no skin issues, while some experienced mild reactions such as redness or itching. Fewer than 2% of patients had significant side effects. This treatment also offers a shorter schedule, which many patients find convenient. While these results are encouraging, side effects can vary from person to person. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Researchers are excited about using adjuvant hypofractionated radiation for breast cancer because it significantly shortens the treatment time compared to traditional radiation therapy. While conventional radiation therapy typically takes five to seven weeks, this approach condenses it into just three to four weeks with 15 sessions. This method not only offers a more convenient schedule for patients but also potentially reduces the side effects associated with longer treatment durations. Additionally, the option to add a targeted "boost" helps focus on areas with a higher risk of recurrence, enhancing the precision and effectiveness of the treatment.

What evidence suggests that this radiation treatment might be effective for breast cancer?

Studies have shown that a shorter course of radiation therapy, known as adjuvant hypofractionated radiation, can be as effective as the traditional, longer course for treating breast cancer. Research indicates that this method helps control the cancer locally and prevents recurrence after surgery. Long-term results demonstrate that it works just as well and offers similar cosmetic outcomes as conventional treatments. Additionally, it does not lead to more side effects over time. This shorter treatment provides a convenient option without sacrificing effectiveness. ^{2 4 6 7 8}

Who Is on the Research Team?

Christine Fisher, MD, MPH

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adult women with breast cancer who've had surgery and found cancer in their lymph nodes. They must be under 50, may have had chemo, and should not have severe side effects from past treatments. Their last surgery or chemo should be within the past 180 days, they need to understand and agree to the study by signing a consent form.

Inclusion Criteria

Before the patient is enrolled, the consent form, including any addenda, must be signed and dated by the patient and the person who explains the study to that patient

Subjects will have the ability to understand, and the willingness to sign a written informed consent document

I am a woman under 50, had chemotherapy, have a specific cancer stage, or am large-breasted.

Exclusion Criteria

Pregnant women

It's been over 6 months since my breast surgery or chemotherapy.

I have had radiation therapy on the same side of my chest or breast before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a shortened course of radiation treatment lasting approximately 3-4 weeks, with 15 treatments and an optional 4 additional fractions as a boost.

3-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments for disease recurrence, metastasis-free survival, and adverse events.

60 months

Long-term Follow-up

Participants are monitored for long-term outcomes such as lymphedema, quality of life changes, and other adverse events.

60 months

What Are the Treatments Tested in This Trial?

Interventions

• Adjuvant Hypofractionated Radiation

Trial Overview The study tests a shorter radiation treatment schedule for breast cancer that has spread to lymph nodes after surgery. It aims to see if this quicker method is as effective as traditional longer courses of radiation therapy.

How Is the Trial Designed?

Group I: Adjuvant Hypofractionated Radiation Experimental Treatment 1 Intervention

Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

A multicenter randomized controlled trial in India is testing whether a 1-week (5 fractions) regimen of hypofractionated radiotherapy is non-inferior to the standard 3-week (15 fractions) schedule for breast cancer patients, with a target sample size of 2100 participants.

If successful, the 1-week regimen could improve access to radiotherapy and reduce treatment costs, while also ensuring safety and efficacy in patients with advanced disease requiring regional nodal radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation therapy comparing a standard radiotherapy schedule (over 3 weeks) with a novel 1-week schedule in adjuvant breast cancer: an open-label randomized controlled study (HYPORT-Adjuvant)-study protocol for a multicentre, randomized phase III trial. Chatterjee, S., Chakraborty, S.[2021]

The UK-FAST trial showed that a once weekly hypofractionated radiotherapy regimen (5 fractions of 5.7 Gy) for whole breast irradiation had similar toxicity levels compared to the conventional regimen (50 Gy in 25 fractions) over a 10-year follow-up, indicating it is a safe alternative.

The FAST-Forward trial demonstrated that a 5-fraction regimen (5.2 Gy per fraction) over one week is non-inferior in local control compared to the standard 40 Gy in 15 fractions over three weeks, supporting the efficacy of extreme hypofractionation in breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Extreme hypofractionation: New indications for breast cancer radiotherapy]. Bockel, S., Louvel, G., Brion, T., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pushing the limits of hypofractionation for adjuvant whole breast radiotherapy. Yarnold, J., Haviland, J.[2018]

A study of 380 breast cancer patients treated with a short hypofractionated radiotherapy schedule showed very low local relapse rates, with only 0.2% at 2 years and 2% at 5 years, indicating high efficacy.

The treatment also resulted in excellent overall survival rates of 97.4% at 2 years and 95% at 5 years, suggesting that this short radiotherapy schedule is a safe and effective alternative to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten Daily Fractions for Whole Breast Cancer Irradiation: Long Term Results. Belgioia, L., Fozza, A., Trapani, L., et al.[2021]

Hypofractionation in radiotherapy for breast cancer has a strong empirical foundation, showing that shorter treatment schedules can be effective.

Clinical trials have successfully established new standards of care, reducing treatment from 50 Gy in 25 fractions over 5 weeks to as low as 26 Gy in 5 fractions over just 1 week, making treatment more efficient for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From 25 Fractions to Five: How Hypofractionation has Revolutionised Adjuvant Breast Radiotherapy. Yarnold, JR., Brunt, AM., Chatterjee, S., et al.[2022]

Radiation therapy (RT) as part of breast-conserving treatment or post-mastectomy significantly reduces the risk of local-regional recurrence and improves long-term survival, with most studies using daily doses of 1.8-2 Gray (Gy).

Recent studies on hypofractionated RT schedules, which deliver equivalent doses in a shorter time, have shown similar effectiveness in preventing recurrence and survival rates, with no significant increase in acute or long-term toxicities, although further research is needed to identify suitable patient groups for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abbreviated course of radiotherapy (RT) for breast cancer. Schoenfeld, JD., Harris, JR.[2018]

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]

The use of hypofractionated radiation therapy (RT) for breast cancer treatment increased from 3.8% in 2006 to 13.6% by 2009-2010 among low-risk older patients, indicating a growing acceptance of this more convenient and cost-effective treatment option.

Despite the increase in hypofractionation use, it remained low overall, especially among patients over 80 years old, while the adoption of intensity-modulated RT (IMRT) rose significantly during the same period, highlighting a disparity in the uptake of these two treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoption of hypofractionated radiation therapy for breast cancer after publication of randomized trials. Jagsi, R., Falchook, AD., Hendrix, LH., et al.[2022]

Hypofractionated radiation therapy, which delivers fewer but larger doses of radiation over a shorter period, has shown comparable outcomes to conventional radiation in treating breast cancer, suggesting it could be an effective alternative.

Ongoing phase 3 trials are investigating hypofractionated whole breast irradiation and accelerated partial breast irradiation, which may lead to broader acceptance of these methods for early-stage breast cancer, although concerns about patient selection and late toxicity remain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation therapy in the treatment of early-stage breast cancer. Freedman, GM.[2021]

Citations

1. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(20)30932-6/fulltext

Hypofractionated breast radiotherapy for 1 week versus 3 ... FAST-Forward results confirm that 26 Gy in five fractions is as effective and safe as an international standard 15-fraction regimen after ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5723786/

The long-term outcome of adjuvant hypofractionated ... Overall, our results revealed that HF showed a comparable long-term efficacy and similar delayed toxic effects to conventional fractionated treatment.

3. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00231-8/fulltext

Ultrahypofractionated Adjuvant Breast Radiation Therapy ... In conclusion, ultrahypofractionated whole breast RT leads to acceptable late toxicity rates at 1 year, even when followed by a hypofractionated ...

4. 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 ...

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

Real World Safety of Adjuvant Ultra Hypofractionated ... Adjuvant radiotherapy (RT) improves local control and progression-free survival rates after conservative or radical surgery in breast cancer.2,3 ...

6. clinical-breast-cancer.com clinical-breast-cancer.com/article/S1526-8209(25)00234-4/abstract

Acute Cutaneous Toxicity and Aesthetic Outcomes Ultra-hypofractionated breast radiotherapy (26 Gy in 5 fractions) was well tolerated. •. More than half of patients showed no skin toxicity; grade 1-2 ...

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

Phase II Evaluation of Ultra-Hypofractionated ... The 3-year disease-free survival probability was 81.7%, and the 3-year overall survival probability was 86.7%. Conclusion. This study ...

8. 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 ...