Comparing hypofractionated and conventional radiotherapy for breast cancer

Hypofractionated Versus Conventional Intensity-Modulated Radiation Therapy for Breast Cancer Patients With an Indication for Regional Nodal Irradiation: A Randomized Multi-center Phase III Trial

This study is testing if a shorter course of radiation treatment is just as safe and effective as the standard longer treatment for breast cancer patients after surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 801 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Ruijin Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT03829553 on ClinicalTrials.gov

What this trial studies

This trial investigates the efficacy and safety of hypofractionated radiotherapy over a shorter duration compared to conventional radiotherapy in breast cancer patients requiring regional nodal irradiation after surgery. Patients will be randomly assigned to receive either hypofractionated radiotherapy or conventional radiotherapy, both delivered using intensity-modulated radiation therapy (IMRT). The study aims to evaluate outcomes such as locoregional recurrence, overall survival, distant metastasis, toxicity, and quality of life over a follow-up period of at least five years.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-75 with unilateral invasive breast cancer who have undergone surgery and have positive axillary lymph nodes.

Not a fit: Patients with certain lymph node involvement or severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and shorter treatment option for breast cancer patients, potentially improving their quality of life.

How similar studies have performed: Other studies have shown promising results with hypofractionated radiotherapy, suggesting this approach may be effective.

Eligibility criteria

Inclusion criteria :

* Age 18-75 years old
* unilateral histologically confirmed invasive breast carcinoma of pT1-3
* breast conservation surgery or mastectomy
* Breast reconstruction is allowed
* histologically confirmed positive axillary lymph nodes (positive sentinel lymph nodes without axillary dissection is allowed)
* Life expectancy of \>5 years
* A minimum negative surgical margin width of \>2mm
* Karnofsky Performance Status ≥80
* Estrogen-receptor, Progesterone-receptor, human epidermal growth factor receptor-2 (HER-2) and Ki67 index can be performed on the primary breast tumor or axillary nodes.
* Written informed consent

Exclusion criteria:

* Supraclavicular lymph nodes, positive ipsilateral internal mammary lymph nodes or residual axillary nodes that may be eligible for a boost dose.
* Pregnant or lactating
* Severe non-neoplastic medical comorbidities
* Diagnosis of non-breast malignancy within 5 years preceding enrollment (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix).
* Simultaneous contralateral breast cancer
* Previous RT to thoracic and/or axillary, cervical region
* Active collagen vascular disease
* Evidence of distant metastatic disease and/or T4 disease

Notes for exlusion criteria:

1. Patients with severe non-neoplastic medical comorbidities (e.g.,severe ischemic heart disease, severe arrhythmia or severe chronic obstructive pulmonary disease ) that would preclude radiation treatment will be excluded.
2. Simultaneous contralateral breast cancer includes histologically confirmed DCIS only.

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jia-Yi Chen

Conditions Breast Cancer; regional nodal irradiation; IMRT; Hypofractionated radiotherapy