Ten Fraction Adjuvant Hypofractionated Radiotherapy in Node Positive Breast Cancer

Breast Cancer Clinical Trial

— HIPOMAMMLINF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792346
• Other study ID #: RS618/14(1611)
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: March 2, 2021

Study information

• Verified date: March 2021
• Source: Regina Elena Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 2, 2021
• Est. primary completion date: January 7, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
Italy	Regina Elena National Cancer Institute	Rome

Sponsors (11)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute	Diana Giannarelli, Francesco Rulli, Giuseppe Sanguineti, Ilaria Farina, Maria Papale, Mauro Caterino, Paola Franzoso, Serena Nucciarelli, Silvia Takanen, Valeria Landoni

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute toxicity assessment	rate of acute toxicity according to CTCAE v4.0 scale	60 months
Secondary	to evaluate late toxicity	rate of late to according to soma lent scale	60 months