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Not yet recruitingLast updated: 12 February 2024

PRESERVE: This study is evaluating the effects of shorter, one week courses of radiation therapy in people with breast cancerPartial Breast Re-irradiation Using Ultra Hypofractionation: Phase 2 Multi-institutional Study (PRESERVE)

Clinical summary

Summary

Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. by reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many people with early stage breast cancer, shorter 1-week (5-fraction) courses of breast radiation have been found to be equivalent to longer schedules in the upfront treatment setting. These 1-week schedules are more convenient for patients, with fewer treatments and shorter overall treatment time. The researchers for this study are investigating the effectiveness of treating people with rPBI with radiation therapy 26Gray(Gy) in 5 daily fractions over 1 week.

Conditions

This trial is treating patients with recurrence of breast cancer

Cancer

Breast Cancers Breast

Age

People18 - 99

Phase

Not applicable

Trial Acronym

PRESERVE

More information

Trial Identifiers

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Trial sponsor

University Health Network, Toronto

Scientific Title

Partial Breast Re-irradiation Using Ultra Hypofractionation: Phase 2 Multi-institutional Study (PRESERVE)

Eligibility

Inclusion

  • Age > 18 years
  • In-breast recurrence confirmed as unicentric
  • Tumour <3.0 cm in greatest diameter on pathologic examination, including both invasive and non-invasive components
  • >1 year after completion of prior adjuvant whole or partial breast radiotherapy
  • Clinically node negative
  • Negative margins (no tumour on ink)
  • Recovered from surgery with the incision completely healed and no signs of infection
  • Negative metastatic work-up (no evidence of distant metastases on bone scan, and computerized tomography (CT) scans of the thorax, abdomen, and pelvis; or using (FDG) Positron emission tomography (PET)-CT).

Exclusion

  • Infiltrating Lobular Carcinoma
  • Multifocal or multicentric disease
  • Extensive intraductal component
  • T4 disease
  • Node positive or distant metastatic disease
  • Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus erythematosus, scleroderma), which would preclude radiation treatment
  • Currently pregnant or lactating
  • Presence of an ipsilateral breast implant or pacemaker
  • Unable to commence radiation within 16 weeks of breast-conserving surgery (or last surgical procedure on the breast) or within 12 weeks from last cycle of adjuvant chemotherapy
  • Unable to clearly define the surgical cavity (Level I oncoplastic procedures are permitted provided the tumor bed is well delineated with surgical clips).
  • Psychiatric disorders which would preclude obtaining informed consent or adherence to protocol
  • Grade II or more late skin toxicity from prior radiation evaluated and graded using CTCAE v5.0

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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