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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: 600cGY x 5 fractions

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lhaden Tshering; Phone Number: 646-962-3118; Email: lht4002@med.cornell.edu

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 10065
      • Recruiting
      • New York Presbyterian Brooklyn Methodist Hospital
      • Contact: Izael Nino; Email: izn4001@med.cornell.edu
      • Principal Investigator: Hani Ashamalla, M.D.
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine
      • Principal Investigator: John Ng, M.D.
      • Contact: Lhaden Tshering, B.S.; Phone Number: 646-962-3118; Email: lht4002@med.cornell.edu
    • New York, New York, United States, 10065
      • Recruiting
      • New York Presbyterian Hospital - Queens
      • Principal Investigator: Akkamma Ravi, M.D.
      • Contact: Hina Ali, M.D; Phone Number: 718-670-1541; Email: hia4002@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Radiation Therapy; 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).	Radiation: 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 EBRT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of treatment related adverse events as graded by CTCAE version 5.0	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.	up to 1 year from completion of radiation treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with late toxicity will be measured as graded by CTCAE version 5.0	Late toxicity is defined as the adverse events experienced by patients after 90 days post radiation therapy.	up to 60 months
Change in number of participants with skin changes	This count of participants will include patients who experience the following: skin hyperpigmentation, fibrosis, telangiectasia, skin induration and edema.	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)	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.	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	Patients will be followed for recurrence of cancer in the treated breast.	60 months
Disease free survival (DFS) will be measured		60 months
Overall Survival (OS) will be measured.		60 months
Number of participants who received subsequent mastectomy in the treated breast	The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast	6 months
Number of participants who received subsequent mastectomy in the treated breast	The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast.	12 months
Number of participants who received subsequent mastectomy in the treated breast	The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast.	24 months
Number of participants who received subsequent mastectomy in the treated breast	The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast.	36 months
Number of participants who received subsequent mastectomy in the treated breast	The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast.	48 months
Number of participants who received subsequent mastectomy in the treated breast	The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast.	60 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: John Ng, M.D., Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 19-07020531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No