Status:
COMPLETED
Ten Fraction Adjuvant Hypofractionated Radiotherapy in Node Positive Breast Cancer
Lead Sponsor:
Regina Elena Cancer Institute
Collaborating Sponsors:
Giuseppe Sanguineti
Silvia Takanen
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 2 2021
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04792346
Start Date
January 1 2015
End Date
March 2 2021
Last Update
March 10 2021
Active Locations (1)
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1
Regina Elena National Cancer Institute
Rome, Italy, 00144