NCT06729814 Prospective Assessment of Acute Skin Toxicities in Breast Cancer Patients Undergoing Retreatment with 40 Gy in 15 Fractions Radiation Therapy
| NCT ID | NCT06729814 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-08-07 |
| Primary Completion | 2025-08-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-08-07 with a primary completion date of 2025-08-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The most common cancer affecting Canadian women is breast cancer, with an estimated 1 in 8 women expected to be diagnosed with breast cancer during their lifetime. Improved screening and treatment have decreased mortality of breast cancer patients, however 14% of cancer-related deaths in Canadian women are still due to breast cancer. Common treatments for breast cancer include surgery, chemotherapy, hormone therapy, and radiation therapy (RT). Despite recent improvements in treatment and preventative screenings, 20% of breast cancer patients will develop local disease recurrence or another ipsilateral primary breast cancer. . The optimal treatment of recurrent or new primary breast cancers for patients who have undergone prior radiotherapy (RT) is not well-defined. Common treatment approaches consist of mastectomy or a second breast conserving surgery (BCS) with whole or partial breast reirradiation (reRT). In the past, mastectomy has been the preferred treatment for recurrent breast cancer due to concerns over serious acute and late skin toxicities that may result from additional reRT. Many of these late skin toxicities, such as fibrosis, are chronic and can result in patients experiencing pain or other negative impacts to quality of life (QOL).
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years old * Informed consent * Histological confirmation of breast malignancy (invasive or in situ carcinoma) or phyllodes * Previous history of ipsilateral breast cancer treated with RT * Patients are planned to receive hypofractionated (40Gy/15) RT to the whole or partial breast or chest wall * Patients treated with or without the addition of a planned boost or bolus * Patients receiving local or locoregional radiation treatment * Can communicate in English or be aided by a translator Exclusion Criteria: * Patients scheduled to receive conventionally fractionated (50Gy/25 or 45Gy/25) or extreme hypofractionation (26Gy/5) * Patients planned to receive brachytherapy * Patients with active rash, pre-existing dermatitis, or other conditions within the treatment area that may make skin assessment for the study difficult per treating physician discretion * Concomitant cytotoxic chemotherapy * Scleroderma
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06729814 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06729814 currently recruiting?
Yes, NCT06729814 is actively recruiting participants. Contact the research team at Irene.karam@sunnybrook.ca for enrollment information.
Where is the NCT06729814 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06729814 clinical trial?
NCT06729814 is sponsored by Sunnybrook Health Sciences Centre. The trial plans to enroll 30 participants.
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