Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer

Conditions

• Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

35 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Radiation — RADIATION
  Radiotherapy given
• No Radiation — OTHER
  No radiotherapy given

Study Details

The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.

Key Dates

Start date

Oct 16, 2018

Status verified

Apr 2026

Primary completion

Sep 1, 2027

Completion

Dec 30, 2027

Study Design

Enrollment

2,140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: No Regional Radiotherapy
  A. Whole Breast Irradiation (WBI) following BCS or; B. No Radiotherapy (RT) following mastectomy
• Active Comparator: Regional Radiotherapy
  A. WBI plus RT to the regional nodes (supraclavicular, non-dissected axillary, and internal mammary) following BCS or; B. RT to the chestwall and regional nodes (supraclavicular, non-dissected axillary, and internal mammary) following mastectomy

Primary Outcome Measure

compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not [ Time Frame: 9.5 years ]

Central Contacts

• Wendy Parulekar
  613-533-6430
  [email protected]

Locations (451)

Find similar trials in Fairbanks, AK

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