Radiation Therapy for Breast Cancer

(PRATO Trial)

Recruiting at 2 trial locations

Overseen By Fereshteh Talebi, MD

Age: Any Age

Sex: Female

Trial Phase: Phase 3

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Male breast cancer, Severe autoimmune, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to use radiation therapy for women with early breast cancer. Researchers are comparing two approaches: one group receives radiation over one week, while another group receives it over two weeks with an additional focused dose aimed at the tumor area. The study examines side effects, changes in breast appearance, and the effectiveness of each treatment in preventing cancer recurrence. Women who have undergone breast-conserving surgery (where the cancer is removed but the breast remains intact) and meet specific cancer criteria may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are undergoing treatment for a severe autoimmune disease, you may not be eligible to participate.

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

Research shows that the 1-week radiation therapy is generally easy for patients to handle. In one study, 85% of women were satisfied with their breast appearance after the 1-week treatment, indicating that most side effects were manageable.

For the 2-week radiation therapy with an extra focused dose (a "boost"), research has examined its safety. Studies found that complications, such as wound problems, were similar to other standard treatments, suggesting it is also well-tolerated.

Both treatment options have undergone testing and are considered safe for patients. This information may help prospective trial participants feel more confident about the safety of these radiation treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these radiation therapy treatments for breast cancer because they offer potentially shorter and more targeted options compared to traditional regimens. Typically, radiation therapy for breast cancer can take several weeks, but one of these treatments condenses the therapy into just one week by delivering 2600 cGy in 5 fractions. The other treatment option not only extends over two weeks but also includes a specialized boost to the tumor bed, delivering 3200 cGy in 10 fractions with an additional 3600 cGy boost, possibly enhancing effectiveness at the tumor site. These approaches aim to maintain or even improve effectiveness while reducing the overall treatment time, which could significantly enhance patient convenience and quality of life.

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

Research has shown that a 1-week radiation therapy schedule for early breast cancer is as effective as a longer 3-week schedule. In this trial, participants in ARM 1 will receive a 1-week schedule of 2600 cGy in 5 fractions of whole breast radiotherapy, offering similar benefits and manageable side effects. This shorter schedule also reduces the number of hospital visits, making it more convenient.

Participants in ARM 2 will undergo a 2-week therapy with 3200 cGy in 10 fractions, including a focused dose, or "boost," to 3600 cGy to the tumor bed. This boost has been shown to significantly reduce the risk of cancer recurrence in the breast. Both methods aim to be effective while minimizing side effects. ^{1 6 7 8 9}

Who Is on the Research Team?

Silvia C. Formenti, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for individuals with early breast cancer. Participants should be suitable for radiation therapy and have no prior treatment that would interfere with the study. Specific details about who can or cannot join are not provided here.

Inclusion Criteria

I have had a segment of my breast removed.

My breast cancer was removed with clear margins.

My breast cancer was removed with clear margins.

Exclusion Criteria

I have had radiation therapy on the same side breast before.

It's been over 90 days since my last surgery, or I had surgery after chemotherapy.

It has been over 60 days since my last chemotherapy session.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 2600 cGy in 5 fractions over one week or 3200 cGy in 10 fractions with a concomitant tumor bed boost over two weeks

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluations of fibrosis, local control, and breast cosmesis

24 months

Long-term follow-up

Participants are monitored for long-term outcomes such as local control and fibrosis at 5 and 10 years

120 months

What Are the Treatments Tested in This Trial?

Interventions

• Radiation therapy - 1 week
• Radiation therapy - 2 weeks

Trial Overview The study compares two radiation therapy schedules: one delivers treatment over one week, while the other spreads it out over two weeks with an additional focused dose to see which is more effective in preventing cancer recurrence and minimizing side effects.

How Is the Trial Designed?

Group I: ARM 2- 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy Experimental Treatment 1 Intervention

Patients randomized to ARM 2 will receive 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy.

Group II: ARM 1-2600 cGy in 5 fractions whole breast radiotherapy Experimental Treatment 1 Intervention

Patients randomized to ARM 1 will receive 2600 cGy in 5 fractions whole breast radiotherapy over one week

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

Radiation therapy (RT) is crucial in breast cancer treatment, effectively reducing local recurrence and mortality, with short courses of RT (3-4 weeks) being as effective as longer ones.

Certain patients, particularly older individuals with good prognosis tumors and clear margins, may safely omit radiation boosts, while untreated regional nodes can lead to reduced survival, highlighting the need for tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation therapy and early breast cancer: current controversies. Boyages, J.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9756602/

Implementation of 26 Gy in five fractions over 1 week ... Rapidly implementing ultrahypofractionated breast radiotherapy is feasible and acute toxicity rates are acceptable even when followed by boost.

2. breastcancer.org breastcancer.org/research-news/accelerated-rads-has-same-effect-as-traditional

Accelerated Radiation Therapy for 1 Week Offers Same ... An accelerated schedule of radiation therapy of 5 treatments over 1 week seems to offer the same benefits as a schedule of 15 treatments over 3 weeks for early ...

3. bmj.com bmj.com/content/386/bmj-2023-079089

Randomised controlled trials on radiation dose ... MHF shows improved safety profile, cosmesis, and quality of life compared with CF while maintaining equivalent oncological outcomes.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0360301625003487

NOVEMBER, A Phase 2 Trial of a 9-Day Course of Whole ... Patient-reported outcomes utilizing the Breast-Q survey revealed breast satisfaction in 85% of women. Conclusions. We demonstrate an effective novel 9 fraction ...

5. researchgate.net researchgate.net/publication/366377380_Implementation_of_26_Gy_in_five_fractions_over_1_week_adjuvant_radiotherapy_for_breast_cancer_Prospective_report_of_acute_skin_toxicity_and_consideration_of_resource_implications

(PDF) Implementation of 26 Gy in five fractions over 1 week ... Delivering this schedule to 135 patients over six months saved 21,300 linac minutes and 1485 hospital visits compared to a 3-week schedule.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06960707?draw=2&rank=1

Two Versus One Week Breast Radiotherapy (RT) This study is comparing two different radiation therapy approaches for early breast cancer to see which one is better for patients. One group will receive ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/15/5/e096677

One-week regimen for postoperative regional irradiation in ... The primary objective is to assess the feasibility of a 1-week regimen of 26 Gy in five fractions for patients with early breast cancer. Both intensity- ...

8. redjournal.org redjournal.org/article/S0360-3016(25)00348-7/fulltext

NOVEMBER, A Phase 2 Trial of a 9-Day Course of Whole ... Patient-reported outcomes utilizing the Breast-Q survey revealed breast satisfaction in 85% of women. Conclusions. We demonstrate an effective ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2452109423002269

A Prospective Trial of Single-Fraction Radiation to the ... Patients then started whole-breast radiation therapy within 1 week of the boost treatment. Patients and treatments were assessed for safety and feasibility.