Postmastecomy Internal Mammary Nodal Irradiation for High-risk Breast Cancer Patients

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT04320979
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • internal mammary nodal irradiation — RADIATION
    chest wall/whole breast and supraclavicular +-axillary plus internal mammary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions). Patients treated with breast-conserving surgery will receive tumor bed boost. Concurrent boost (60 Gy in 25 fractions over 5 weeks or 49.5 Gy in 15 fractions over 3 weeks) or sequential boost (10 Gy in 5 fractions over 1 week or 8.7 Gy in 3 fractions over 3 days) is optional.
  • no internal mammary nodal irradiation — RADIATION
    chest wall/whole breast and supraclavicular+-axillary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions). Concurrent boost (60 Gy in 25 fractions over 5 weeks or 49.5 Gy in 15 fractions over 3 weeks) or sequential boost (10 Gy in 5 fractions over 1 week or 8.7 Gy in 3 fractions over 3 days) is optional.

Study Details

The purpose of this study is to evaluate the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients treated with mastectomy or breast-conserving surgery.

Key Dates

Start date
May 8, 2020
Status verified
Jan 2026
Primary completion
Nov 1, 2025
Completion
May 31, 2030

Study Design

Enrollment
2,400 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: internal mammary nodal irradiation
    chest wall/whole breast and supraclavicular nodal+-axillary plus internal mammary nodal irradiation
  • Active Comparator: no-internal mammary nodal irradiation
    ipsilateral chest wall/whole breast and supraclavicular +-axillary nodal irradiation

Primary Outcome Measure

disease-free survival [ Time Frame: 5 years ]

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