Ten Fraction Adjuvant Hypofractionated Radiotherapy in Node Positive Breast Cancer

a Feasibility Study of Accelerated Hypofractionated Radiotherapy in Node Positive Breast Cancer Patients Treated With Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04792346

Acronym

HIPOMAMMLINF

Enrollment

Registered

2021-03-10

Start date

2015-01-01

Completion date

2021-03-02

Last updated

2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

hypofractionated RT, cosmetic outcome, locoregional treatment

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).

Interventions

RADIATIONbreast/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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
acute toxicity assessment	60 months	rate of acute toxicity according to CTCAE v4.0 scale

Secondary

Measure	Time frame	Description
to evaluate late toxicity	60 months	rate of late to according to soma lent scale

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026