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Recruiting NCT04371913

Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 600cGY x 5 fractions APBI, 270cGy x 15 fractions WBRT.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 19 years — 90 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Personalized Second Chance Breast Conservation (PSCBC): A Two Center Prospective Phase II Clinical Study

Overview

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. An additional goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with inbreast recurrences after a previous lumpectomy and PBI, the investigators propose to test whole breast RT (WBRT) with the target as the whole breast volume.

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 or with the fractionation of 4050 cGy in 15 fractions over 3 weeks, based on the previous treatment that they received.

The main aim of the study is to evaluate the rate of early grade 3 toxicities with this approach.

Interventions

  • Radiation 600cGY x 5 fractions APBI
    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 EBRT
  • Radiation 270cGy x 15 fractions WBRT
    Patients will be treated with the fractionation of 4050 cGy in 15 fractions over 3 weeks, which is the standard whole breast RT (WBRT) fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT)

Primary outcome measures

  • Rate of treatment related adverse events as graded by CTCAE version 5.0 [Time frame: up to 1 year from completion of radiation treatment]
Secondary outcome measures (12)
  • Number of participants with late toxicity will be measured as graded by CTCAE version 5.0 [Time frame: up to 60 months]
  • Change in number of participants with skin changes [Time frame: baseline, approx. week 1- week 2 of radiation, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months.]
  • Change in Quality of life as assessed by Breast Cancer treatment outcome scale (BCTOS) [Time frame: baseline, approx. week 1- week 2 of radiation, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months.]
  • Number of participants who demonstrate local control [Time frame: 60 months]
  • Disease free survival (DFS) will be measured [Time frame: 60 months]
  • Overall Survival (OS) will be measured. [Time frame: 60 months]
  • Number of participants who received subsequent mastectomy in the treated breast [Time frame: 6 months]
  • Number of participants who received subsequent mastectomy in the treated breast [Time frame: 12 months]
  • Number of participants who received subsequent mastectomy in the treated breast [Time frame: 24 months]
  • Number of participants who received subsequent mastectomy in the treated breast [Time frame: 36 months]
  • Number of participants who received subsequent mastectomy in the treated breast [Time frame: 48 months]
  • Number of participants who received subsequent mastectomy in the treated breast [Time frame: 60 months]

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
  • Previous WBI or IORT, brachytherapy or external beam partial breast treatment
  • 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
  • Extensive Intraductal Component

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • New York Presbyterian Brooklyn Methodist Hospital — Brooklyn
  • New York Presbyterian Hospital - Queens — New York
  • Weill Cornell Medicine — New York

Identifiers

NCT: NCT04371913 · 19-07020531

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗