Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study
- Conditions
- Breast Cancer
- Interventions
- Radiation: 600cGY x 5 fractions
- Registration Number
- NCT04371913
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
The goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with in-breast recurrences after a previous lumpectomy and RT, investigators propose to test partial breast irradiation with the target volume encompassing the entire surgical bed with 1.0-1.5 cm margins.
- Detailed Description
Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for Radiation Therapy (RT) naïve patients at New York Presbyterian using EBRT.
The main aim of the study is to evaluate the rate of early grade 3 toxicities with this approach.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- Isolated ipsilateral unifocal breast lesions
- Limited size (< 2-3 cm) without evidence of skin involvement
- Histologically proven invasive breast carcinoma or carcinoma in situ
- Negative histologic margins of resection
- Patients with 0 to 3 positive axillary lymph nodes without extracapsular extension
- No synchronous distant metastases
- Age ≥ 18 years
- ≥ 12 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence
- Technical feasibility
- Every kind of systemic therapy is allowed
- Informed consent for clinical and research purposes signed
- Regional recurrences (axillary, supraclavicular)
- Positive histologic margins at resection
- Metastatic disease
- Poor cosmesis from previous surgery and RT
- Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment
- Extensive Intraductal Component
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiation Therapy 600cGY x 5 fractions Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT).
- Primary Outcome Measures
Name Time Method Rate of treatment related adverse events as graded by CTCAE version 5.0 up to 1 year from completion of radiation treatment The primary endpoint of the study is to test the feasibility in terms of acute toxicity of a protocol of partial breast re-irradiation for breast cancer treatment in a previously irradiated whole breast, as defined by the rate of grade ≥ 3 treatment-related skin, fibrosis, and breast pain AEs, as graded by CTCAE version 5.0.
- Secondary Outcome Measures
Name Time Method Number of participants with late toxicity will be measured as graded by CTCAE version 5.0 up to 60 months Late toxicity is defined as the adverse events experienced by patients after 90 days post radiation therapy.
Change in Quality of life as assessed by Breast Cancer treatment outcome scale (BCTOS) baseline, approx. week 1- week 2 of radiation, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months. The Breast Cancer Treatment Outcomes Scale (BCTOS) will be used to evaluate patient-reported cosmetic outcome, functional status, and breast pain. Each BCTOS subscale (cosmetic, functional status, and breast pain) is calculated by computing the arithmetic mean of the answers to each item relevant to a given subscale. The score is a continuous variable ranging from 1 to 4, with 1 indicating no difference between the treated and untreated breast, 2 indicating a slight difference, 3 indicating a moderate difference, and 4 indicating a large difference.
Overall Survival (OS) will be measured. 60 months Number of participants who received subsequent mastectomy in the treated breast 60 months The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast.
Change in number of participants with skin changes baseline, approx. week 1- week 2 of radiation, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months. This count of participants will include patients who experience the following: skin hyperpigmentation, fibrosis, telangiectasia, skin induration and edema.
Disease free survival (DFS) will be measured 60 months Number of participants who demonstrate local control 60 months Patients will be followed for recurrence of cancer in the treated breast.
Trial Locations
- Locations (3)
Weill Cornell Medicine
🇺🇸New York, New York, United States
New York Presbyterian Hospital - Queens
🇺🇸New York, New York, United States
New York Presbyterian Brooklyn Methodist Hospital
🇺🇸Brooklyn, New York, United States