Ultra-hypofractionated Radiation for Breast Cancer

Recruiting at 5 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Disqualifiers: Stage IV cancer, Paget's 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: 6

Duration: 1 week

82 Participants Needed

Trial Summary

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 trial coordinators or your doctor.

What data supports the effectiveness of the treatment Ultra-hypofractionated Radiation for Breast Cancer?

Research shows that ultra-hypofractionated radiation, which uses fewer but larger doses of radiation, is as effective as traditional methods for treating early-stage breast cancer. It has been found to be safe and well-tolerated, with similar or reduced side effects, and is more convenient for patients due to fewer treatment visits. ^{1 2 3 4 5}

Is ultra-hypofractionated radiation for breast cancer safe?

Research shows that ultra-hypofractionated radiation for breast cancer is generally safe, with studies reporting no significant difference in side effects compared to traditional methods. Trials like the UK-FAST and FAST-Forward have demonstrated a safe toxicity profile over several years. ^{1 6 7 8 9}

How is ultra-hypofractionated radiation treatment different from other breast cancer treatments?

Ultra-hypofractionated radiation treatment for breast cancer is unique because it delivers a higher dose of radiation in fewer sessions, typically over one week, compared to traditional methods. This approach is designed to be more convenient and cost-effective while maintaining similar safety and effectiveness in controlling cancer. ^{1 2 6 10 11}

What is the purpose of this trial?

This clinical trial tests how well ultra-hypofractionated (UF) whole breast irradiation (WBI) with lumpectomy cavity boost (CB) works in treating patients with stage I-III breast cancer. Breast conservation therapy (BCT) is the recommended treatment for patients with early stage breast cancer. BCT involves a lumpectomy followed by breast radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Traditionally, WBI has been given once daily over 5-6 weeks and then those at high-risk for recurrence receive additional radiation (boost) to the lumpectomy cavity daily over 4-8 days. This has now been replaced by moderate hypofractionated radiation. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Although moderate hypofractionated radiation therapy reduces the length of treatment from 6-7 weeks to 3-4 weeks, the length of treatment still remains a barrier for many patients. UF-WBI with CB delivers radiation to the whole breast and the surgical cavity at the same time over 5 daily treatments. Giving UF-WBI with CB may prevent recurrence and prolong survival as well as improve the quality of life in patients with stage I-III breast cancer.

Research Team

Stephanie M Yoon

Principal Investigator

City of Hope Comprehensive Cancer Center

Eligibility Criteria

This trial is for patients with stage I-III breast cancer who have undergone a lumpectomy. It's designed to test an advanced form of radiation therapy that could shorten treatment time and potentially improve quality of life.

Inclusion Criteria

My breast cancer diagnosis was confirmed through a tissue examination.

I have had surgery to check the lymph nodes under my arm.

If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

Exclusion Criteria

Pregnant or breastfeeding

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

My cancer has spread to the lymph nodes needing radiation that includes the area above my collarbone.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ultra-hypofractionated whole breast irradiation with lumpectomy cavity boost once daily for up to 5 fractions

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Follow-up at 1 month, 6 months, then annually

Treatment Details

Interventions

• Lumpectomy Cavity Boost
• Ultra-hypofractionated Whole Breast Irradiation

Trial Overview The study examines ultra-hypofractionated whole breast irradiation combined with a boost to the lumpectomy cavity, aiming to treat breast cancer more efficiently over just five daily sessions instead of the usual weeks.

Participant Groups

Group I: Treatment (UF-WBI with CB) Experimental Treatment 5 Interventions

Patients undergo UF-WBI with CB QD on consecutive business days for up to 5 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CBCT prior to each radiation treatment.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study involving 396 patients treated with ultra-hypofractionated breast radiotherapy, the five-year local-relapse free survival (LRFS) rate was an impressive 98.8%, indicating high efficacy in controlling breast cancer.

While ultra-hypofractionated radiotherapy showed excellent tumor control, certain regimens, particularly the 5.7 Gy weekly fraction and tumor bed boost, were linked to a higher risk of acute and late skin toxicities, highlighting the need for careful treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large scale experience of two ultrahypofractionated 5 fractions regimes after breast conserving surgery from a single centre. Sauvage, LM., Loap, P., Vu-Bezin, J., et al.[2023]

Hypofractionated whole breast irradiation (WBI) has been shown to produce outcomes comparable to conventional radiation in early-stage breast cancer patients, suggesting it is a safe and effective treatment option.

Current trials, including a phase III study by the Radiation Therapy Oncology Group, are investigating the feasibility and effectiveness of adding a concurrent tumor bed boost to hypofractionated WBI, which may enhance treatment outcomes and broaden its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated fractionation with a concurrent boost for early stage breast cancer. Freedman, GM., White, JR., Arthur, DW., 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]

The UK-FAST-Forward study indicated that ultra-hypofractionated whole-breast irradiation (ultra-HF-WBI) is not inferior to traditional high-fractionated whole-breast irradiation, but safety concerns have prevented its use in Japan.

A new phase II trial involving 98 patients aims to assess the safety of ultra-HF-WBI after breast-conserving surgery, focusing on the occurrence of late adverse events over 3 years, which could influence future treatment guidelines in Japan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-institutional phase II study of ultra-hypofractionated whole-breast irradiation after breast-conserving surgery for breast cancer in Japan: Kyoto Radiation Oncology Study Group (UPBEAT study). Mitsuyoshi, T., Ono, Y., Ashida, R., et al.[2023]

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]

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]

Hypofractionation for whole-breast irradiation is safe and effective, providing similar local control and cosmetic outcomes compared to traditional methods, as supported by recent randomized trials.

There is growing interest in using hypofractionation for partial-breast irradiation, with early studies showing promising local control and manageable side effects, while larger randomized trials are currently being conducted to further evaluate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience using hypofractionated radiation schedules in breast cancer. Whelan, TJ., Kim, DH., Sussman, J.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Large scale experience of two ultrahypofractionated 5 fractions regimes after breast conserving surgery from a single centre. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Accelerated fractionation with a concurrent boost for early stage breast cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

European Society for Radiotherapy and Oncology Advisory Committee in Radiation Oncology Practice consensus recommendations on patient selection and dose and fractionation for external beam radiotherapy in early breast cancer. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Hypofractionated boost after whole breast irradiation in breast carcinoma: chronic toxicity results and cosmesis. [2022]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Multi-institutional phase II study of ultra-hypofractionated whole-breast irradiation after breast-conserving surgery for breast cancer in Japan: Kyoto Radiation Oncology Study Group (UPBEAT study). [2023]

7. France pubmed.ncbi.nlm.nih.gov

[Extreme hypofractionation: New indications for breast cancer radiotherapy]. [2021]

8. United States 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Patient preference study comparing hypofractionated versus conventionally fractionated whole-breast irradiation after breast-conserving surgery. [2019]

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

Clinical experience using hypofractionated radiation schedules in breast cancer. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

Comparison of hypofractionated and conventionally fractionated whole-breast irradiation for early breast cancer patients: a single-institute study of 1,098 patients. [2018]