Ultra-hypofractionated Radiation for Breast Cancer

Recruiting at 7 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new form of radiation treatment to determine its effectiveness in treating stage I-III breast cancer. The focus is on ultra-hypofractionated whole breast irradiation (UF-WBI) with a special boost, aiming to reduce treatment time to just five days while still preventing cancer recurrence. This approach could improve quality of life by shortening treatment duration compared to traditional methods. Women who have had a lumpectomy for breast cancer and possess certain high-risk features might be suitable candidates for this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

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 prior data suggests that this radiation therapy protocol is safe for breast cancer patients?

Studies have shown that ultra-hypofractionated whole breast irradiation (UF-WBI) is generally well-tolerated. The FAST-Forward trial found that administering 26 Gy (a unit of radiation) in 5 sessions over one week was safe and effective for early breast cancer patients. This approach allowed treatment completion in fewer visits without increasing side effects.

Another study reported low rates of immediate harmful effects, indicating few short-term side effects and no significant changes in appearance after treatment. Earlier research demonstrates that this type of radiation treatment has a good safety record.

Overall, these findings suggest that UF-WBI is a safe option for treating breast cancer, with manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for breast cancer?

Ultra-hypofractionated Whole Breast Irradiation (UF-WBI) is unique because it offers a faster, more convenient radiation therapy option for breast cancer patients. Unlike traditional radiation treatments that can take several weeks, UF-WBI delivers higher doses over only five sessions, potentially reducing treatment time significantly. Researchers are excited about this approach because it aims to maintain effectiveness while minimizing the burden on patients' schedules and reducing their exposure to radiation over time. Additionally, using Cone Beam Computed Tomography (CBCT) before each session ensures precise targeting of the cancer, which can enhance treatment accuracy and safety.

What evidence suggests that ultra-hypofractionated whole breast irradiation with lumpectomy cavity boost is effective for breast cancer?

Research has shown that ultra-hypofractionated whole breast irradiation (UF-WBI), which participants in this trial will receive, effectively treats breast cancer. One study found it reduced the risk of recurrence by 16% over 10 years. Another study demonstrated that the cancer remained controlled in the treated area for 98.7% of patients over three years. Patients experienced fewer immediate side effects, known as low levels of acute toxicity. These findings suggest that UF-WBI is a promising treatment for patients with stage I-III breast cancer, offering shorter treatment times with effective results. ^{1 5 6 7 8}

Who Is on the Research Team?

Stephanie M Yoon

Principal Investigator

City of Hope Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12364632/

Impact on outcomes of ultra hypofractionation or ... Overall, it reduced the risk of recurrence by 16% at 10 years and breast cancer-specific survival by 4% at 15 years. Different groups exhibit ...

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

Once-Weekly Ultra-Hypofractionated Radiation Therapy for ... The regimen achieved high locoregional control (98.7% at 3 years) with low acute and late toxicity, particularly with the 28.5 Gy schedule. •.

3. 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.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06902311

Ultra Hypo-fractionated Adjuvant Whole Breast Radiation ... This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in ...

6. redjournal.org redjournal.org/article/S0360-3016(24)00772-7/fulltext

Early Safety of Ultra-Hypofractionated Whole Breast ... The Phase 3 FAST-Forward trial showed that 26 Gy in 5 fractions over 1 week for whole breast irradiation (WBI) was safe and efficacy for early breast cancer ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05914831

Ultra-hypofractionated for Whole Breast Irradiation (WBI) ... Radiation therapy should ideally start 6-8 weeks after breast-conserving surgery but no later than 12 weeks after the surgery. If adjuvant chemotherapy has been ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0360301624007727

103 Early Safety of Ultra-Hypofractionated Whole Breast ... The Phase 3 FAST-Forward trial showed that 26 Gy in 5 fractions over 1 week for whole breast irradiation (WBI) was safe and efficacy for ...