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NCT Number: NCT06559696

Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy

The aim of this study is to explore the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients (ypN+or supra/subclavicular lymph node positive) after neoadjuvant chemotherapy.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location status: Recruiting

Location contact

Yong Yang, Doctor

CONTACT

[email protected]

18813019084

About this study

This is a prospective, randomized phase 3 trial. Breast cancer patients with axillary lymph node-positive or supra/subclavicular lymph node metastasis underwent neoadjuvant chemotherapy were included. Patients underwent regional nodal irradiation along with breast or chest wall irradiation and randomly allocated to either IMNI or no IMNI.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed invasive breast cancer
  • Underwent neoadjuvant chemotherapy
  • Eastern Cooperative Oncology Group Performance Status Scale 0-2
  • ypN+ after neoadjuvant chemotherapy or supraclavicular/subclavicular lymph node metastasis before system therapy
  • No distant metastases
  • No internal mammary nodes metastases based on images before system therapy
  • Willing to follow up
  • Written,informed consent

Exclusion criteria

  • Without neoadjuvant chemotherapy
  • Distant metastases
  • Simultaneous bilateral breast cancer
  • Pathological confirmation or imaging consideration of lymph node metastasis in the internal mammary before system therapy
  • Had simultaneous or previous secondary malignancies, except for non-malignant melanoma skin cancer, papillary thyroid / follicular carcinoma, cervical carcinoma in situ, contralateral non-invasive breast cancer

Treatment and study plan

internal mammary nodal irradiation

Radiation

chest wall/whole breast and supraclavicular +-axillary plus internal mammary nodal irradiation (50 Gy in 25 fractions or 40Gy in 15 fractions).

No internal mammary node irradiation

Radiation

chest wall/whole breast and supraclavicular +-axillary irradiation (50 Gy in 25 fractions or 40Gy in 15 fractions).

Primary outcomes

  1. Disease free survival

    Time frame: 5 years

    From date of enrollment until to the first recurrence in the ipsilateral breast or chestwall, the regional nodal area, or a distant site or death due to any cause

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

    From date of enrollment until the date of death from any cause.

  2. Distant metastasis-free survival

    Time frame: 5 years

    The time of randomization to the first recurrence in a distant site.

  3. Local-regional recurrence-free survival

    Time frame: 5 years

    The time of randomization to the first recurrence in the ipsilateral breast or chest wall and the regional nodal area.

Study contacts

Contact information is provided by the study sponsor or research team.

Yong Yang, M.S

CONTACT

[email protected]

18813019084

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Registry information

Official study title

Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy: a Phase III Randomized, Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2032
Study completion
2032
First posted
Aug 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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