Ten Fraction Adjuvant Hypofractionated Radiotherapy in Node Positive Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT04792346
• Lead Sponsor: Regina Elena Cancer Institute

Brief Summary

Post-operative loco-regional (LR) hypofractionated radiotherapy (Hypo-RT) is an attractive approach in locally advanced breast cancer (LABC).

Detailed Description

The present is a single arm phase II study assessing toxicity levels after 34 Gy/10 fxs/2 wks to the whole breast/chest wall and to the draining lymph nodes; an optional single fraction 8 Gy boost was administered with electrons to the tumor bed in patients who had undergone conservative surgery. Both acute (CTCAE v4.0) and late (LENT/SOMA) toxicity were collected. All pts but those who underwent mastectomy without reconstruction or with temporary expander were also asked to rate their cosmetic outcome according to the Harvard. Toxicity was assessed weekly during RT and then at each follow-up examination (1, 3, 6 months and then yearly).

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2019-01-07
• Status Verified: 2021-03
• Study Completion: 2021-03-02
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-09
• Last Update Submitted: 2021-03-09
• Study First Posted: 2021-03-10
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

Inclusion Criteria

• Patients affected by invasive breast cancer who underwent conservative breast surgery or mastectomy and axillary dissection, followed by post operative radiotherapy at the level of the breast/chest wall, and of the supraclavicular, third axillary level +/- internal mammary chain nodes.
• pT1-3 disease pN1-2, cT1-3 disease if neoadjuvant chemotherapy , cN + cytologically and/or histologically assessed;
• ECOG Performance status ≤2;
• histologically negative surgical margins
• no distant metastases
• no prior chest radiotherapy
• life expectancy ≥ 5 years
• no prior cancer

Exclusion Criteria

• Non-epithelial breast cancer (sarcoma, lymphoma etc.)
• Metastases at the level of the internal chain mammary and / or supra-clavicular lymph nodes histologically assessed
• pT4 neoplasms or inflammatory breast carcinoma
• Distant metastasis
• Concomitant chemotherapy
• history of prior controlateral breast tumor

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
acute toxicity assessment	60 months	rate of acute toxicity according to CTCAE v4.0 scale

Secondary Outcome Measures

Name	Time	Method
to evaluate late toxicity	60 months	rate of late to according to soma lent scale

Trial Locations

Locations (1)

Regina Elena National Cancer Institute; 🇮🇹 Rome, Italy