SMC Radiation Oncology Breast Cancer Cohort Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Hypofractionated radiation therapy: Both 3-week and 1-week hypofractioanted radiation therapy are allowed. (simultaneous or sequential tumor bed boost is allowed.) A 3-week regimen includes 42.4 Gy in 16 fractions. A 1-week regimen includes 26 Gy in 5 fractions or 28.5 Gy in 3 fractions, 30 Gy in 5 fractions.

Study summary

The goal of this observational study is to learn about toxicities and cosmetic outcomes in breast cancer patients treated with hypofractionated radiotherapy.

The main question it aims to answer are:

* Changes in breast skin
* Factors related to breast skin changes
* Patient-reported outcomes
* Cosmetic outcomes

Participants will be assessed by multi-dimensional methods before and after radiotherapy:

* Photographs
* Fibrometer
* Questionnaires (BREAST-Q)
* CTCAE version 4.03 evaluated by treating physicians

Eligibility

Primary outcome measure(s)

• Change of cosmesis from baseline — After 2-3 weeks after the start of radiation therapy (During radiation therapy)
  Evaluated by two blinded independent physicians based on photographs
• Change of cosmesis from baseline — 2-3 weeks after the completion of radiation therapy
  Evaluated by two blinded independent physicians based on photographs
• Change of cosmesis from baseline — 6 months after radiation therapy
  Evaluated by two blinded independent physicians based on photographs
• Change of cosmesis from baseline — 1 year after radiation therapy
  Evaluated by two blinded independent physicians based on photographs
• Change of cosmesis from baseline — 2 year after radiation therapy
  Evaluated by two blinded independent physicians based on photographs
• Change of cosmesis from baseline — 5 year after radiation therapy
  Evaluated by two blinded independent physicians based on photographs
• Change of fibrosis from baseline — After 2-3 weeks after the start of radiation therapy (During radiation therapy)
  Evaluated using fibrometer measuring both breast
• Change of fibrosis from baseline — 2-3 weeks after the completion of radiation therapy
  Evaluated using fibrometer measuring both breast
• Change of fibrosis from baseline — 6 months after radiation therapy
  Evaluated using fibrometer measuring both breast
• Change of fibrosis from baseline — 1 year after radiation therapy
  Evaluated using fibrometer measuring both breast
• Change of fibrosis from baseline — 2 year after radiation therapy
  Evaluated using fibrometer measuring both breast
• Change of fibrosis from baseline — 5 year after radiation therapy
  Evaluated using fibrometer measuring both breast
• Change of patient-reported outcome from baseline — After 2-3 weeks after the start of radiation therapy (During radiation therapy)
  BREAST-Q questionnaire is used to evaluate patient-reported outcome.
• Change of patient-reported outcome from baseline — 2-3 weeks after the completion of radiation therapy
  BREAST-Q questionnaire is used to evaluate patient-reported outcome.
• Change of patient-reported outcome from baseline — 6 months after radiation therapy
  BREAST-Q questionnaire is used to evaluate patient-reported outcome.
• Change of patient-reported outcome from baseline — 1 year after radiation therapy
  BREAST-Q questionnaire is used to evaluate patient-reported outcome.
• Change of patient-reported outcome from baseline — 2 year after radiation therapy
  BREAST-Q questionnaire is used to evaluate patient-reported outcome.
• Change of patient-reported outcome from baseline — 5 year after radiation therapy
  BREAST-Q questionnaire is used to evaluate patient-reported outcome.
• Physician assessed toxicity — After 2-3 weeks after the start of radiation therapy
  CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
• Physician assessed toxicity — 2-3 weeks after the completion of radiation therapy
  CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
• Physician assessed toxicity — 6 months after radiation therapy
  CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
• Physician assessed toxicity — 1 year after radiation therapy
  CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
• Physician assessed toxicity — 2 year after radiation therapy
  CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
• Physician assessed toxicity — 5 year after radiation therapy
  CTCAE version 4.03 is used to evaluate physician-assessed toxicities.

Trial sites (1)

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