400 Participants Needed

Radiation Therapy for Breast Cancer

(PRATO Trial)

Recruiting at 2 trial locations
FG
FT
Overseen ByFereshteh Talebi, MD
Age: Any Age
Sex: Female
Trial Phase: Phase 3
Sponsor: Weill Medical College of Cornell University
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

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. However, if you are undergoing treatment for a severe autoimmune disease, you may not be eligible to participate.

What data supports the effectiveness of the treatment Radiation Therapy for Breast Cancer?

Research shows that shorter courses of radiation therapy, like those lasting 3-4 weeks, are generally as effective as longer ones for early breast cancer, reducing local recurrence and mortality. Additionally, accelerated treatments focusing on the tumor bed have been evaluated for their potential to reduce treatment time while maintaining effectiveness.12345

Is radiation therapy for breast cancer safe?

Research shows that a 1-week radiation therapy schedule for breast cancer is generally safe, with studies reporting on acute skin reactions and other short-term effects. Long-term safety data from the FAST-Forward trial also supports its safety compared to traditional longer schedules.678910

How does the 1-2 week radiation therapy for breast cancer differ from other treatments?

This treatment is unique because it significantly shortens the duration of radiation therapy for breast cancer to just 1-2 weeks, compared to the traditional 6-7 weeks. This accelerated schedule can reduce the time and cost burden on patients while still effectively targeting the cancer.1571112

What is the purpose of this trial?

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 radiation over one week (based on the FAST-FORWARD trial), and the other group will receive radiation over two weeks with an extra focused dose (called a "concomitant boost"). The study will look at how the treatments affect side effects, breast appearance, and cancer control in the breast. It also aims to find out if the two-week treatment does a better job at preventing cancer from coming back in the breast over the long term.

Research Team

SC

Silvia C. Formenti, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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.
See 3 more

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.
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: ARM 2- 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGyExperimental Treatment1 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 radiotherapyExperimental Treatment1 Intervention
Patients randomized to ARM 1 will receive 2600 cGy in 5 fractions whole breast radiotherapy over one week

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

Findings from Research

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

References

Comparison of three concomitant boost techniques for early-stage breast cancer. [2019]
Radiation therapy and early breast cancer: current controversies. [2019]
Inflammatory carcinoma of the breast: treatment results on 107 patients. [2019]
Fraction size in radiation treatment for breast conservation in early breast cancer. [2018]
Accelerated treatment of breast cancer. [2018]
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. [2023]
Four-week course of radiation for breast cancer using hypofractionated intensity modulated radiation therapy with an incorporated boost. [2018]
Impact of radiation therapy on acute toxicity in breast conservation therapy for early breast cancer. [2022]
One versus three weeks hypofractionated whole breast radiotherapy for early breast cancer treatment: the FAST-Forward phase III RCT. [2023]
Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Novel and Highly Compressed Schedules for the Treatment of Breast Cancer. [2018]
Late cosmetic results of short fractionation for breast conservation. [2022]
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