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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-08

Study Completion Date

2030-05-31

Brief Summary

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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.

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Detailed Description

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Eligible patients are randomized into 2 groups: chest wall/whole breast and supraclavicular nodal +-axillary plus internal mammary nodal irradiation, and chest wall/whole breast and supraclavicular nodal +-axillary nodal irradiation. The prescription dose is 50 Gy in 25 fractions over 5 weeks or 43.5Gy in 15 fractions over 3 weeks. Breast cancer patients treated with breast-conserving surgery will receive tumor bed boost.

During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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internal mammary nodal irradiation

chest wall/whole breast and supraclavicular nodal+-axillary plus internal mammary nodal irradiation

Group Type EXPERIMENTAL

internal mammary nodal irradiation

Intervention Type 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

ipsilateral chest wall/whole breast and supraclavicular +-axillary nodal irradiation

Group Type ACTIVE_COMPARATOR

no internal mammary nodal irradiation

Intervention Type 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.

Interventions

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internal mammary nodal irradiation

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.

Intervention Type RADIATION

no internal mammary nodal irradiation

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.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Eastern Cooperative Oncology Group Performance Status Scale 0-2
* Histologically confirmed invasive breast cancer
* Underwent total mastectomy/breast-conserving surgery and axillary dissection(10 or more axillary lymph nodes detected) and negative margins
* Patients who had ≥4 positive axillary lymph nodes; or 1-3positive axillary lymph nodes and T3-4; or 1-3positive axillary lymph nodes and T1-2, and score≥3 based on the following high risk factors: age≤40 years(score 1), primary tumor in the inner quadrant (score 1), 2-3 positive axillary lymph nodes (score 1), positive vascular invasion (score 1), re-staged based on eighth Cancer Staging System staging system(IB-IIA score 1， IIB-IIIA score 2); or ypN+ after neoadjuvant chemotherapy
* No supraclavicular or internal mammary nodes metastases based on images before system therapy
* No distant metastases
* Could tolerate radiotherapy
* Treated with chemotherapy (anthracycline and/or taxane-based combined chemotherapy, ≥6 cycles)
* Anticipated to receive endocrine therapy for 5 years if indicated
* Anticipated to receive anti-HER2 therapy for 1 years if indicated
* LVEF≥50% based on echocardiogram
* Willing to follow up
* Written,informed consent

Exclusion Criteria

* Simultaneous bilateral breast cancer
* Sentinel lymph node biopsy only without axillary dissection
* Had received internal mammary node dissection
* No imaging assessment of the internal mammary nodal before system therapy
* One-stage breast reconstruction
* Severe cardiac insufficiency; myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina in the last 3 months; pericardial disease
* Had history of chest wall or supraclavicular radiotherapy
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No