Shortened (hypofractionated) versus conventional radiotherapy in early breast cancer after election by the patient

• Conditions: C50; Malignant neoplasm of breast

• Registration Number: DRKS00005618
• Lead Sponsor: niversitätsklinikum DresdenKlinik für Strahlentherapie und Radioonkologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 789

Inclusion Criteria

Women> 40 years (on the day of surgery her breast cancer)
- Status after breast-conserving surgery, R0 with a sufficient safety distance in accordance with applicable S3 guideline
- tumor stage pT1-2, pN0 N1mi, M0 or ductal carcinoma in situ of the breast with an indication for radiotherapy
- status after sentinel node biopsy or axillary dissection
- indication for radiotherapy of the breast
- patient is able to attend regular follow-ups

Exclusion Criteria

- indication for radiotherapy of the regional lymphatic drainage according S3 guideline
- previous breast cancer or DCIS
- bilateral breast cancer
- previous radiotherapy of the breast or thorax
- breast implants (regardless of side)
- pregnant or lactating women
- comorbidities that might increase the radiosensitivity, particularly dermatomyositis, systemic lupus erythematosus or scleroderma, symptomatic cardiac or pulmonary disease, puncture needy seroma of the breast, existing breast infection
- conditions that prevent the patient at the completion of radiotherapy or in participating in the follow-ups

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
chronic toxicity (fibrosis of the breast -> stage 2; 3 years after radiation therapy; analysis by scoring (CTC-AE v4))

Secondary Outcome Measures

Name	Time	Method
- local tumor control (mammography, sonography in each case after 3 years)<br><br>- acute toxicity (3 years after radiation therapy; chronic toxicity of the skin > stage 2 (scoring CTCAE v4), cosmetic result (foto and self-assesment), quality of life (questionnaire))