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Completed

NCT Number: NCT01463007

Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer

The purpose of this study is to evaluate the rate of early and intermediate toxicity related to the AccuBoost System for delivery of APBI in women with resected, early stage breast cancer.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center For Cancer Care and Research- Watson Clinic, Lakeland, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A confirmed histological diagnosis of invasive breast carcinoma or DCIS
  • Age greater or equal to 50 years old
  • Life expectancy > 6 months
  • Treated by breast conserving surgery with axillary node dissection or sentinel lymph node biopsy
  • Pathologic tumor size less than or equal to 2 cm
  • Invasive ductal, mucinous, tubular or colloid histology
  • Estrogen receptor positive for invasive carcinoma.
  • Unifocal/unicentric disease
  • Negative surgical margins greater than or equal to 2 mm
  • Pathologic lymph node negative
  • No evidence of lymphovascular invasion
  • ECOG performance status of 0 or 1 (Appendix 1)
  • Informed consent signed.

Exclusion criteria

  • Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)
  • Autoimmune disorder
  • Pregnancy
  • Breast implants
  • Psychiatric or addictive disorder that would preclude attending follow-up
  • Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted)
  • Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)
  • Lobular features on histology (pure or mixed) or sarcoma histology
  • Node positive on axillary dissection or in the sentinel lymph node biopsy;
  • Extensive in situ carcinoma (EIC)
  • Multicentric or multifocal disease
  • Paget's disease of the nipple
  • Distant metastases
  • Lumpectomy cavity not well visualized on AccuBoost imaging
  • Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator (PTV > 6cm)
  • Breast separation with compression > 7cm.
  • Overlap of skin between orthogonal treatment axes.

Treatment and study plan

Accelerated Partial Breast Irradiation

Radiation

Accuboost APBI 34.0 Gy in 10 fractions

Extended Follow up

Other

This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed.

Primary outcomes

  1. Early and Intermediate Toxicity

    Time frame: 2 years

    Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.

Secondary outcomes

  1. Cosmetic Outcome

    Time frame: 2 years

    Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table.

Sponsors and collaborators

Lead sponsor

Jaroslaw Hepel

Other

Collaborators

  • Rhode Island Hospital
  • The Miriam Hospital

Registry information

Official study title

ACCELERATED PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (ACCUBOOST) FOR EARLY STAGE BREAST CANCERS: A TOXICITY ASSESSMENT

Important dates

Study start
2011
Primary completion
2013
Study completion
2021
First posted
Nov 1, 2011
Registry last updated
May 19, 2021

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

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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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