Personalized Second Chance for Breast Conservation: A Phase II Study

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04371913

Provider View

This study is exploring a new approach to give patients another opportunity for breast conservation after a recurrence of breast cancer following a previous lumpectomy and radiation therapy. The study will test partial breast irradiation targeting the surgical area with a small margin.

Patient Parameters

Program Overview

The aim of this study is to see if it's possible to offer a second chance at breast conservation for patients who have had a recurrence of breast cancer in the same breast after a previous lumpectomy and radiation treatment. Researchers will use a method called partial breast irradiation, which focuses radiation on the area around the surgical site with a small margin. This approach will be tested to see if it can be done safely and effectively.

Description

Participants in this study will receive a specific type of radiation treatment called external beam radiation therapy (EBRT). The treatment will be given in 5 sessions over 1 to 2 weeks, with a total dose of 30 Gy. This is a faster treatment schedule that is typically used for patients who have not had radiation therapy before.

The main goal of the study is to check for any early side effects that are more severe, known as grade 3 toxicities, from this treatment approach.

Eligibility Criteria

Inclusion Criteria

  • Have a single breast cancer lesion on the same side as the previous cancer.
  • The cancer must be small (less than 2-3 cm) and not involve the skin.
  • Have a confirmed diagnosis of invasive breast cancer or carcinoma in situ.
  • The cancer must have been completely removed with clear margins.
  • Have 0 to 3 positive lymph nodes in the armpit area, without spread beyond the nodes.
  • No cancer spread to other parts of the body.
  • Be 18 years or older.
  • At least 12 months must have passed since the initial breast-conserving treatment and the recurrence.
  • The treatment must be technically possible.
  • Any type of systemic therapy is allowed.
  • Must sign an informed consent for participation in the study.

Exclusion Criteria

  • Cancer recurrence in the regional lymph nodes (armpit or above the collarbone).
  • Cancer not completely removed with clear margins.
  • Cancer that has spread to other parts of the body.
  • Poor cosmetic outcome from previous surgery and radiation.
  • Previous breast radiation using intraoperative radiation therapy (IORT), brachytherapy, or partial breast treatment.
  • Extensive intraductal component in the cancer.

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