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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371913
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : April 19, 2023
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: 600cGY x 5 fractions Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalized Second Chance Breast Conservation (PSCBC): A Two Center Prospective Phase II Clinical Study
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of treatment related adverse events as graded by CTCAE version 5.0 [ Time Frame: 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 :
  1. Number of participants with late toxicity will be measured as graded by CTCAE version 5.0 [ Time Frame: up to 60 months ]
    Late toxicity is defined as the adverse events experienced by patients after 90 days post radiation therapy.

  2. 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. ]
    This count of participants will include patients who experience the following: skin hyperpigmentation, fibrosis, telangiectasia, skin induration and edema.

  3. 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. ]
    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.

  4. Number of participants who demonstrate local control [ Time Frame: 60 months ]
    Patients will be followed for recurrence of cancer in the treated breast.

  5. Disease free survival (DFS) will be measured [ Time Frame: 60 months ]
  6. Overall Survival (OS) will be measured. [ Time Frame: 60 months ]
  7. Number of participants who received subsequent mastectomy in the treated breast [ Time Frame: 6 months ]
    The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast

  8. Number of participants who received subsequent mastectomy in the treated breast [ Time Frame: 12 months ]
    The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast.

  9. Number of participants who received subsequent mastectomy in the treated breast [ Time Frame: 24 months ]
    The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast.

  10. Number of participants who received subsequent mastectomy in the treated breast [ Time Frame: 36 months ]
    The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast.

  11. Number of participants who received subsequent mastectomy in the treated breast [ Time Frame: 48 months ]
    The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast.

  12. Number of participants who received subsequent mastectomy in the treated breast [ Time Frame: 60 months ]
    The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371913


Contacts
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Contact: Pragya Yadav, Ph.D. 646-962-2199 pry2003@med.cornell.edu
Contact: Marvin Campos, B.S. 646-962-3118 mac4039@med.cornell.edu

Locations
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United States, New York
New York Presbyterian Brooklyn Methodist Hospital Recruiting
Brooklyn, New York, United States, 10065
Contact: Izael Nino       izn4001@med.cornell.edu   
Contact: Pragya Yadav    646-962-2199    pry2003@med.cornell.edu   
Principal Investigator: Hani Ashamalla, M.D.         
New York Presbyterian Hospital - Queens Recruiting
New York, New York, United States, 10065
Contact: Hina Ali, M.D    718-670-1541    hia4002@med.cornell.edu   
Contact: Pragya Yadav    6469622199    pry2003@med.cornell.edu   
Principal Investigator: Akkamma Ravi, M.D.         
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Pragya Yadav, Ph.D.    646-962-2199    pry2003@med.cornell.edu   
Contact: Charles Ekeh, M.D.    646-962-3118    che4005@med.cornell.edu   
Principal Investigator: John Ng, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: John Ng, M.D. Weill Medical College of Cornell University
More Information
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04371913    
Other Study ID Numbers: 19-07020531
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: April 19, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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