Ten Fraction Adjuvant Hypofractionated Radiotherapy in Node Positive Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2021-03-02

Brief Summary

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

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Detailed Description

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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).

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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breast/chest wall radiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No