Clinical trial NCT04371913: Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study
Official title: Personalized Second Chance Breast Conservation (PSCBC): A Two Center Prospective Phase II Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of treatment related adverse events as graded by CTCAE version 5.0
timeFrame: up to 1 year from completion of radiation treatment
Secondary outcomes:
measure: Number of participants with late toxicity will be measured as graded by CTCAE version 5.0
timeFrame: up to 60 months
measure: Change in number of participants with skin changes
timeFrame: baseline, approx. week 1- week 2 of radiation, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months.
measure: Change in Quality of life as assessed by Breast Cancer treatment outcome scale (BCTOS)
timeFrame: baseline, approx. week 1- week 2 of radiation, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months.
measure: Number of participants who demonstrate local control
timeFrame: 60 months
measure: Disease free survival (DFS) will be measured
timeFrame: 60 months
measure: Overall Survival (OS) will be measured.
timeFrame: 60 months
measure: Number of participants who received subsequent mastectomy in the treated breast
timeFrame: 6 months
measure: Number of participants who received subsequent mastectomy in the treated breast
timeFrame: 12 months
measure: Number of participants who received subsequent mastectomy in the treated breast
timeFrame: 24 months
measure: Number of participants who received subsequent mastectomy in the treated breast
timeFrame: 36 months
measure: Number of participants who received subsequent mastectomy in the treated breast
timeFrame: 48 months
measure: Number of participants who received subsequent mastectomy in the treated breast
timeFrame: 60 months
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: New York Presbyterian Brooklyn Methodist Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Queens
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: John Ng, M.D.
role: PRINCIPAL_INVESTIGATOR
References: