Ten Fraction Adjuvant Hypofractionated Radiotherapy in Node Positive Breast Cancer

Regina Elena Cancer Institute61 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer

Interventions

breast/chest wall radiotherapyRADIATION

34 Gy/10 fxs/2 wks to the whole breast/chest wall and locoregional lymph nodes; an optional single fraction 8 Gy boost was administered with electrons to the tumor bed in patients undergoing conservative surgery

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Regina Elena National Cancer Institute

Rome, Italy

Outcomes

Primary Outcomes

acute toxicity assessment

rate of acute toxicity according to CTCAE v4.0 scale

Time frame: 60 months

Secondary Outcomes

to evaluate late toxicity

rate of late to according to soma lent scale

Time frame: 60 months

Data from ClinicalTrials.gov

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