Clinical trial NCT05289466: Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.
Official title: Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IORT-Intra-Operative Radiation Therapy
Lead sponsor: Saint John's Cancer Institute
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, Non-randomized, Single-arm
Primary purpose: TREATMENT

Brief summary: Prospective, Non-randomized, Single-arm.The objectives of this study are to evaluate cosmesis and perioperative complications associated with the use of intraoperative radiotherapy (IORT) at the time of partial mastectomy in patients with breast cancer and a prior history of radiation therapy. Secondary objectives include evaluating effectiveness of partial mastectomy with IORT, measured by local, regional and distant recurrence, mastectomy rate, and disease-specific and overall survival.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 50 y.o.
* Histologically proven in situ and invasive ductal or lobular breast recurrence
* Prior history of whole breast/chest wall radiation therapy
* Disease span ≤ 3 cm, unifocal
* No nodal disease (N0)
* No evidence of metastatic disease (M0)
* Time from initial BCT should be ≥ 1 year
* Patients have refused the standard of care of mastectomy
* Skin distance of ≥ 0.8 cm between applicator and skin

Exclusion Criteria:

* Multifocal and/or multicenter recurrence

  * N1-3 status: Regional cytological or histologically proven node recurrence
  * M1 status: Metastatic disease
  * cT4 (Skin or muscle involvement) or Paget's disease of the nipple
  * Patients undergoing mastectomy
  * Patients undergoing neoadjuvant systemic therapy
  * Connective tissue disease or scleroderma, contraindicating radiotherapy

Primary outcomes:
measure: Cosmetic Outcomes as evaluated using BREAST-Q questionnaire as a measure of patient-reported ratings.
timeFrame: 5 years
measure: Cosmetic Outcomes as evaluated using the Harvard Breast Cosmesis Grading Scale as a measure of patient-reported ratings.
timeFrame: 5 years
measure: Cosmetic Outcomes as evaluated by clinician completion of the Harvard Breast Cosmesis Grading Scale
timeFrame: 5 years
measure: Perioperative complications as documented using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (CTCAE.v5) scoring system.
timeFrame: 5 years
Secondary outcomes:
measure: Effectiveness of partial mastectomy with IORT, measured by local recurrence.
timeFrame: 5 years
measure: Effectiveness of partial mastectomy with IORT, measured by regional recurrence.
timeFrame: 5 years
measure: Effectiveness of partial mastectomy with IORT, measured by distant recurrence.
timeFrame: 5 years
measure: Effectiveness of partial mastectomy with IORT, measured by mastectomy rate.
timeFrame: 5 years
measure: Effectiveness of partial mastectomy with IORT, measured by disease-specific survival.
timeFrame: 5 years
measure: Effectiveness of partial mastectomy with IORT, measured by overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Providence Saint John's Hospital
state: California
Study officials:
affiliation: Saint John's Cancer Institute
name: Janie L Weng Grumley, MD
role: PRINCIPAL_INVESTIGATOR
References: