Two Versus One Week Breast Radiotherapy (RT)

Official title

Prospective Randomized Trial of Two Versus One Week Accelerated Radiotherapy (PRATO)

Overview

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.

Detailed description

Radiotherapy: one week (Arm 1) 2600 cGy in 5 fractions whole breast radiotherapy over one week versus 2 weeks (Arm 2), 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy. In Arm 2, if no cavity is visible due to oncoplastic surgery, we will deliver 32 Gy to the whole breast only, without a boost.

Hypothesis: A regimen of whole breast radiotherapy to 2600 in five fractions, the current UK standard for early breast cancer (Arm 2), is not inferior to 3200cGy with a concomitant tumor bed boost to 3600 cGy in 10 fractions (Arm 1), in terms of acute toxicity and long-term fibrosis, breast cosmesis and local control at 2 and 5 years. It will also test the hypothesis of superior local control at 10 years in Arm 2 compared to Arm 1.

Interventions

• Radiation Radiation therapy - 1 week
  2600 cGy whole breast radiotherapy in five fractions (Arm 1) over 1 week
• Radiation Radiation therapy - 2 weeks
  3200 cGy whole breast radiotherapy with a concomitant tumor bed boost to 3600 cGy in 10 fractions (Arm 2) over 2 weeks. In Arm 2, if no cavity is visible due to oncoplastic surgery, we will deliver 32 Gy to the whole breast only, without a boost.

Primary outcome measures

• Rate of RT-related acute toxicity [Time frame: 1 month]

Secondary outcome measures (7)

• The long-term evaluations at 2 years of fibrosis based on LENT/SOMA [Time frame: 24 months]
• The long-term evaluations at 2 years of breast cosmesis [Time frame: 24 months]
• The long-term evaluations at 2 years of local control [Time frame: 24 months]
• The long-term evaluations at 5 years OF fibrosis based on LENT/SOMA [Time frame: 60 months]
• The long-term evaluations at 5 years of breast cosmesis [Time frame: 60 months]
• The long-term evaluations at 5 years of local control. [Time frame: 60 months]
• Superior local control at 10 years [Time frame: 120 months]

Eligibility criteria

Inclusion criteria

• Women status post segmental mastectomy.
• If unilateral, pT1-2 breast cancer excised with negative margins.
• If bilateral, pT1-2 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
• Clinically N0 (cN0 as determined by ultrasound/SOUND criteria) or pN0-1 or Nx or sentinel node negative.
• Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).
• Women with previous contralateral treated breast cancer can be enrolled in the trial.

Exclusion criteria

• Previous radiation therapy to the ipsilateral breast.
• >90 days from last surgery, unless s/p adjuvant chemotherapy.
• >60 days from last chemotherapy.
• Male breast cancer.
• Ongoing treatment for severe autoimmune disease.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 3 centers

• Brooklyn Methodist Hospital — New York
• New York Presbyterian Hospital — New York
• New York-Presbyterian Weill Cornell Medical College — New York

Identifiers

NCT: NCT06960707 · 25-01028391

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗