Comparing two types of radiotherapy after breast cancer surgery
Postmastectomy Hypofractionated Versus Conventional Fractionated Radiotherapy in High Risk Breast Cancer: a Phase III Randomized Clinical Trial
This study is testing whether a new type of radiotherapy given in fewer sessions is just as safe and effective as the standard treatment for women with high-risk breast cancer after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1494 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Suzhou, Jiangsu and 2 other locations) |
| Trial ID | NCT03856372 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of hypofractionated adjuvant radiotherapy compared to conventional fractionated radiotherapy in women with high-risk breast cancer who have undergone mastectomy. Participants will be randomly assigned to receive either 50 Gy in 25 fractions or 42.5 Gy in 16 fractions of radiotherapy, administered five times a week. The primary focus is on loco-regional recurrence rates, while also monitoring other cancer-related events and radiation-related side effects over a follow-up period of 10 years. The goal is to determine if the hypofractionated approach is as effective and safe as the conventional method.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-75 with pathologically confirmed invasive breast cancer who have undergone mastectomy and axillary dissection with specific high-risk features.
Not a fit: Patients with concurrent or previous malignancies, or those who have received prior radiotherapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more efficient and potentially less toxic radiotherapy option for high-risk breast cancer patients.
How similar studies have performed: Other studies have shown promising results with hypofractionated radiotherapy approaches, suggesting potential for success in this study as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Age18-75 years * Pathologically confirmed invasive breast cancer * Treated with mastectomy and axillary lymph node dissection with more than 10 resected lymph nodes. Immediate or delayed ipsilateral breast cancer reconstruction is accepted * Negative surgical margins * Pathologic T1-2N1 with at least one of the following risk factors: \<40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression, or pT3-4, or pN2-3 (four or more positive axillary lymph nodes) * No distant metastases * No supraclavicular or internal mammary nodes metastases * ECOG:0-1 * Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted. * No neoadjuvant chemotherapy * Fit for postoperative radiotherapy. No contraindications to radiotherapy * Signed informed consent Exclusion Criteria: * Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin * Previous radiotherapy to the chest wall or regional lymph node areas * Patients with severe non-malignant comorbidity in cardiovascular or respiration system * Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis * pT1-2N1 with none of the following risk factors: \<40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression * Patients with supraclavicular or internal mammary nodes metastases * Known definitive clinical or radiologic evidence of metastatic disease * Bilateral breast cancer or historically confirmed contralateral invasive breast cancer * Treated with neoadjuvant chemotherapy * ECOG: 3-4 * Pregnant or lactating * Conditions indicating that the patient cannot go through the radiation therapy or follow up * Unable or unwilling to sign informed consent
Where this trial is running
Suzhou, Jiangsu and 2 other locations
- Suzhou Municipal hospital — Suzhou, Jiangsu, China (Not_yet_recruiting)
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
- Huangpu Branch, Shanghai ninth people's hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Jinli Ma, MD, PhD — Fudan University
- Study coordinator: Jinli Ma, MD, PhD
- Email: jinli.ma@aliyun.com
- Phone: +86-15221033376
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.