Evaluating the omission of internal mammary irradiation in early-stage breast cancer
Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer Patients According to Clinical-genomic Model: an Open Label, Non-inferior Randomized Controlled Trial
This study is testing if women with early-stage breast cancer can safely skip a specific type of radiation treatment while still getting other necessary radiation to see if it helps them just as much.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04517266 on ClinicalTrials.gov |
What this trial studies
This study aims to determine whether internal mammary irradiation (IMI) can be safely omitted in women with early-stage intermediate risk (N1) breast cancer. It is a phase II open-label, non-inferior randomized controlled trial comparing two treatment approaches: one that includes IMI and one that does not, both combined with whole breast/chest wall irradiation and supraclavicular irradiation. The study utilizes a clinical-genomic model to identify patients who may benefit from omitting IMI based on their individual risk factors and genomic profiles. Participants will be randomized based on their clinical and genomic risk assessments to evaluate safety and effectiveness outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-80 with histologically confirmed invasive breast cancer, having undergone radical surgery, with 1-3 positive lymph nodes and classified as clinical high risk with low genomic risk.
Not a fit: Patients with fewer than 2 clinical risk factors or those with axillary dissection of less than 10 lymph nodes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment plans for breast cancer patients, potentially reducing unnecessary radiation exposure.
How similar studies have performed: Previous studies have explored similar genomic approaches in breast cancer treatment, indicating potential for success, though this specific approach remains novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Histologically confirmed invasive breast cancer * Underwent radical surgery with either mastectomy or breast conserving surgery and axillary lymph node dissection (ALND) * The number of positive lymph node should be 1-3 (N1). * Clinical high risk breast cancer (≥2 clinical risk factors) * Aged 18-80 years old * ECOG performance status ≤2 (Karnofsky ≥70%) Anticipative overall survival \>5 years Pathologically surgical margin \>2mm ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor Women of child-bearing potential must agree to use adequate contraception for up to 1 month before study treatment and the duration of study participation Ability to understand and willingness to participate the research and sign the consent form Exclusion Criteria: * • Axillary dissection of less than 10 lymph nodes * Pathologically positive ipsilateral supraclavicular lymph node * Pathologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes * Pregnant or lactating women * Treated with breast reconstruction surgery * Severe non-neoplastic medical comorbidities * History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix * simultaneous contralateral breast cancer * Previous radiotherapy to the neck, chest and/or ipsilateral axillary region * Active collagen vascular disease * Definitive pathological or radiologic evidence of distant metastatic disease * Primary T4 tumor * Interval between radical surgery (mastectomy or breast conserving surgery) and radiotherapy was more than 12 weeks or interval between last dose of adjuvant chemotherapy and radiotherapy was more than 8 weeks
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin Hospital, Shanghai jiaotong univestigy school of medicine — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Wei-Xiang Qi, Dr. — Ruijin Hospital
- Study coordinator: Wei-Xiang Qi, Dr.
- Email: qiweixiang1113@163.com
- Phone: +862164370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.