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NCT Number: NCT05976412

Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer

This study is a non blind, randomized controlled study, whose hypothesis was that chest wall/whole breast combined regional lymph node radiotherapy can improve the 5-year disease-free survival rate of clinical high-risk pN0 breast cancer patients.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Jiayi Chen, Dr.

PRINCIPAL_INVESTIGATOR

Yifeng Wang

CONTACT

[email protected]

+862164370045

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Voluntarily participate and sign an informed consent form; Age>18 years old, female; received radical surgery for breast cancer, including breast conservation surgery or mastectomy, combined with Sentinel lymph node biopsy or axillary lymph node dissection; Invasive cancer, postoperative axillary lymph node negative, with pathological staging of T1-3N0M0 stage (Stage IA, IIA, IIB); including two or more high-risk factors based on four clinical high-risk recurrence factors [tumor size (>2cm), tumor site (medial and central quadrants), Ki-67 level (>14%), and vascular status (positive)]; KPS ≥ 80, estimated survival time >5 years; Complete healing of Surgical incision, no incision infection, etc; Reproductive period women should undergo contraception for at least one month before study, and promise to use contraception throughout the entire study period and continue until the specified time after the end of the study

Exclusion criteria

Pregnant or lactating women; Received neoadjuvant therapy; with serious non neoplastic medical complications that affect the implementation of radiotherapy; History of malignant tumor in the past 5 years (excluding previous lobular Carcinoma in situ, skin Basal-cell carcinoma, skin Carcinoma in situ, cervical Carcinoma in situ and lung Carcinoma in situ); Simultaneous contralateral breast cancer; Previous history of neck, chest, or ipsilateral axillary radiotherapy; Active collagen vascular disease; distant metastasis confirmed by pathology or imaging;

Treatment and study plan

Regional lymph node radiotherapy

Radiation

Regional lymph node radiotherapy

chest/whole breast irradiation

Radiation

chest/whole breast irradiation

Primary outcomes

  1. 5 year disease free survival rate

    Time frame: 5 year

    Disease free survival rate from randomization to 5 years after radiotherapy

Secondary outcomes

  1. 5 year local reginal recurrence rate

    Time frame: 5 year

    The proportion of local or regional recurrence from randomization to 5 years after radiotherapy

  2. 5 year distant metastases rate

    Time frame: 5 year

    The proportion of distant metastases occurring 5 years after radiotherapy

  3. 5 year overall survival rate

    Time frame: 5 year

    The proportion of death occurring 5 years after radiotherapy

Study contacts

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

Dan Ou, MD

CONTACT

[email protected]

8618801970632

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Prospective Randomized Controlled Study on Precision Irradiation of Regional Lymph Node for Clinical High-risk pN0 Breast Cancer

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Aug 4, 2023
Registry last updated
Aug 7, 2023

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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