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Completed

NCT Number: NCT04792346

Ten Fraction Adjuvant Hypofractionated Radiotherapy in Node Positive Breast Cancer

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Regina Elena National Cancer Institute

Rome, 00144, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

breast/chest wall radiotherapy

Radiation

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

Primary outcomes

  1. acute toxicity assessment

    Time frame: 60 months

    rate of acute toxicity according to CTCAE v4.0 scale

Secondary outcomes

  1. to evaluate late toxicity

    Time frame: 60 months

    rate of late to according to soma lent scale

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Collaborators

  • Diana Giannarelli
  • Francesco Rulli
  • Giuseppe Sanguineti
  • Ilaria Farina
  • Maria Papale
  • Mauro Caterino
  • Paola Franzoso
  • Serena Nucciarelli
  • Silvia Takanen
  • Valeria Landoni

Registry information

Official study title

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

Acronym: HIPOMAMMLINF

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
Mar 10, 2021
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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