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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
19 Years to 90 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether more radiation can help people keep their breast when breast cancer returns after surgery to remove the tumor and radiation. It tests radiation to part or all of the breast, based on the radiation given before.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older, with signed consent for treatment and research.
  • Cancer has returned in only one spot in the same breast, with no spread to distant parts of the body.
  • The tumor is smaller than 2–3 cm and has not reached the skin.
  • A tissue test shows breast cancer that has grown into nearby tissue or stays where it started.
  • No cancer cells are found at the edges of the tissue removed during surgery.
  • Cancer is in no more than 3 armpit lymph nodes and has not grown outside those nodes.
  • At least 12 months have passed between the first breast-saving treatment and the cancer’s return. Prior radiation may have treated all or part of the breast.
  • The study treatment must be possible to give. Any type of medicine that treats cancer throughout the body is allowed.

Who can't join

  • Cancer has returned in nearby areas, such as the armpit or above the collarbone.
  • Cancer cells are found at the edges of the tissue removed during surgery.
  • Cancer has spread to distant parts of the body.
  • Earlier surgery and radiation left the breast with a poor appearance.
  • A large amount of cancer is present within the breast’s milk ducts.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (3)

NY