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Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer

ConditionsEarly Stage Breast CarcinomaBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

This prospective study is designed to evaluate the feasibility, efficacy, and safety of risk-stratified hypofractionated radiotherapy after breast-conserving surgery in patients with early breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ECOG performance status score of 0 to 2.

Pathologically confirmed breast cancer, including invasive carcinoma or ductal carcinoma in situ.

Clinical stage cT0-2N0M0.

Underwent breast-conserving surgery.

Disqualifiers

Regional lymph node metastasis.

Distant metastasis.

Bilateral breast cancer.

Prior thoracic radiotherapy.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Whole-breast irradiation and tumor bed boost

    Radiation

    Whole-breast irradiation: 36 Gy in 15 fractions; Tumor bed boost: 48 Gy in 15 fractions

  • Partial-breast irradiation

    Radiation

    Partial-breast irradiation: 40.05 Gy in 15 fractions or 26 Gy in 5 fractions

Treatment groups

649 Participants
are divided into 2 treatment groups
Group A: Arm 1: High-risk groupActive comparator 1 intervention
Group B: Arm 2: Low-risk groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Local recurrence rate

Ipsilateral breast recurrence rate

Time frame
Five years

Secondary outcomes

1

Disease-free survival rate

Disease-free survival rate

Time frame
Five years
2

Radiation-related adverse events

Adverse events

Time frame
Five years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: