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NCT Number: NCT04371913

Personalized Second Chance Breast Conservation (PSCBC): A 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.

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

New York Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

600cGY x 5 fractions APBI

Radiation

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

270cGy x 15 fractions WBRT

Radiation

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 outcomes

  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 outcomes

  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. Participants completing the BCTOS is optional.

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fabiana Gregucci

CONTACT

[email protected]

646-962-3110

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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

Acronym: Second Chance

Important dates

Study start
2020
Primary completion
2030
Study completion
2035
First posted
May 1, 2020
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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