Radiation Therapy for Breast Cancer

(FAST NOVEMBER Trial)

Overseen By Rachel Kingsford

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Utah

Must not be taking: Radiation sensitizing medications

Disqualifiers: Bilateral breast cancer, prior chemotherapy, 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

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether 5 days or 9 days of whole breast radiation is more effective for treating breast cancer. It includes individuals who have undergone a lumpectomy for breast cancer that hasn't spread. Women aged 18 or older, who have recently had a lumpectomy and have not received prior chest radiation or chemotherapy, might be suitable candidates. The trial aims to determine the optimal radiation schedule to enhance outcomes and potentially reduce side effects. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take medications that make radiation more effective during the study.

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

Research has shown that whole breast radiotherapy administered over 5 days is generally safe and well-tolerated. Most patients do not experience severe side effects. More than half report no skin problems, and when side effects occur, they are usually mild. Comparisons with longer schedules have found this treatment to be equally safe and effective. Thus, the 5-day approach is a good and safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these breast cancer treatments because they offer potentially more convenient options compared to traditional whole breast radiotherapy, which typically involves numerous sessions over several weeks. The trial is testing two different approaches: one with 5 fractions and another with 9 fractions of radiotherapy. These shorter regimens could significantly reduce the treatment duration for patients, potentially improving quality of life without compromising effectiveness. This shift towards fewer sessions aims to maintain the therapeutic benefits while lessening the burden on patients and healthcare systems.

What evidence suggests that this trial's treatments could be effective for breast cancer?

This trial will compare two different schedules of whole breast radiotherapy for treating breast cancer. Research has shown that five sessions of whole breast radiotherapy are effective. Participants in this trial may receive this five-session schedule, which the FAST-Forward trial found to be as effective and safe as the traditional method of 15 sessions over three weeks. This means fewer sessions can control cancer just as effectively, saving time and resources. Additionally, studies indicate that this shorter schedule does not cause more breast volume loss compared to other methods. This suggests that the five-day treatment is a strong option for patients seeking effective and efficient therapy. Another group of participants will receive nine sessions of radiotherapy, which the trial will evaluate for effectiveness and safety. ^{1 4 6 7 8}

Who Is on the Research Team?

Matthew R. Poppe, MD

Principal Investigator

Huntsman Cancer Institute

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older with early-stage breast cancer who've had a lumpectomy. They must not be pregnant, agree to use contraception if of childbearing potential, and have an ECOG Performance Status ≤ 2 or KPS ≥ 50. Women over 50 need additional risk factors like aggressive tumor grade or low estrogen receptor positivity.

Inclusion Criteria

I am a woman aged 18 or older.

Negative pregnancy test for participants of childbearing potential, evidence of permanent surgical sterilization, or post-menopausal status

Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria

Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study

I am currently on medication or therapy to enhance the effects of radiation.

My condition makes me more sensitive to radiation treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive either 5 or 9 fractions of whole breast radiotherapy

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Long-term follow-up

Participants are monitored for long-term radiation-related adverse events and recurrence rates

5-8 years

What Are the Treatments Tested in This Trial?

Interventions

• Whole Breast Radiotherapy

Trial Overview The study compares two durations of whole breast radiation therapy: a short course of five days versus a longer nine-day treatment in patients with early-stage breast cancer following lumpectomy surgery.

How Is the Trial Designed?

Group I: 5 fractions of radiotherapy (Arm 1) Experimental Treatment 1 Intervention

Group II: 9 fractions of radio therapy (Arm 2) Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

Implementing a radiation dermatitis (RD) prevention protocol significantly improved oncology nurses' confidence in assessing and managing RD in breast cancer patients, as shown by surveys completed by 11 nurses before and after an education session.

The protocol led to a statistically significant increase in the use of topical steroids for RD prophylaxis, which is expected to help reduce the incidence of dermatologic adverse events during radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation Dermatitis: A Prevention Protocol for Patients With Breast Cancer. Lucas, AS., Lacouture, M., Schneider, SM.[2019]

Radiation therapy is an effective and safe option for breast conservation therapy in localized breast cancer, with careful consideration of factors like patient history and breast size.

Acute skin reactions during treatment do not predict long-term complications, suggesting that with proper techniques, most patients can achieve good outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservation Therapy of the Breast: Optimizing Long-term Results. Greenberg, HM.[2019]

In a study of 703 Japanese women who underwent breast-conserving surgery and radiation therapy, common late adverse events included breast pain, fibrosis, and pneumonitis, with serious complications (Grade 2 or 3) occurring in only 3.8% of patients.

The cosmetic outcomes were favorable, with 69.1% of patients reporting excellent or good results, indicating that the treatment is effective not only in managing cancer but also in preserving breast appearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter investigation of late adverse events in Japanese women treated with breast-conserving surgery plus conventional fractionated whole-breast radiation therapy. Nozaki, M., Kagami, Y., Mitsumori, M., et al.[2022]

Radiation therapy is an effective treatment for both ductal carcinoma in situ (DCIS) and invasive breast cancer, with lumpectomy followed by radiation being particularly effective for DCIS.

Shorter radiation schedules are just as effective as traditional longer regimens for early breast cancer, and postmastectomy radiation provides survival benefits for high-risk premenopausal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation treatment for breast cancer. Recent advances. Chow, E.[2018]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.19.02750

Ten-Year Results of FAST: A Randomized Controlled Trial ... The FAST Trial (CRUKE/04/015) evaluated normal tissue effects (NTE) and disease outcomes after 5-fr regimens. Ten-year results are presented.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11483319/

Resource implications of evolving breast cancer radiotherapy ... The introduction of ultrahypofractionated 26Gy/5 radiotherapy resulted in the greatest saving of resource costs, €47,489, and staff time, 13,820 ...

3. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/study-confirms-breast-volume-preservation-with-five-day-radiation-therapy

Preserving Breast Volume with 5-Day RT - Consult QD New study findings suggest that breast volume loss isn't worse following five-fraction whole versus partial breast radiation therapy, adding ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0936655521001734

Original Article Five-fraction Radiotherapy for Breast Cancer The phase 3 FAST-Forward trial reported outcomes for 26 and 27 Gy schedules delivered in 5 fractions over 1 week versus 40 Gy in 15 fractions over 3 weeks ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9057640/

Five-Year Longitudinal Analysis of Patient-Reported ... Patient-reported outcomes over 5 years after whole- or partial-breast radiotherapy: Longitudinal analysis of the IMPORT LOW (CRUK/06/003) phase III ...

7. 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 ...

8. thegreenjournal.com thegreenjournal.com/article/S0167-8140(25)00210-5/fulltext

Results from the phase III FAST-Forward trial randomised ... FAST-Forward showed that 26 Gray (Gy) in 5 fractions (Fr) over one week adjuvant radiotherapy to breast or chest wall was as safe and effective as a three-week ...