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Completed

NCT Number: NCT00944528

Single Dose Partial Breast Radiotherapy

This study seeks to determine the maximum tolerated dose of a single-dose partial breast radiation given before lumpectomy using a radiosurgery technique. Lumpectomy will be performed within 3 weeks (+/- 1 week) of completing radiation.

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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

55 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

This study will assess the safety of partial breast radiosurgery as measured by the incidence of acute toxicity and wound healing complications in three dose cohorts.

Patients will be enrolled in cohorts of 8 patients starting at dose level 1 (15 Gy). If 2 or more dose limiting toxicities (DLTs) are observed at dose level 1, the trial will be stopped for evaluation and consideration of revision. If at most one DLT is observed then escalation continues to the next dose level. The cohorts will escalate by 3Gy up to 21 Gy of irradiation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women with a biopsy proven diagnosis of low/intermediate grade ductal carcinoma in situ or invasive ductal (or other favorable histology) carcinoma of the breast
  • Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
  • Clinical T1N0M0
  • 55 years of age or older
  • Estrogen receptor (ER) positive,
  • No evidence of lymphovascular space invasion on initial biopsy
  • Not pregnant. If not post-menopausal must adhere to birth control measures
  • White blood cell count > 3000, Hemoglobin > 9, platelets >100000
  • Must be eligible for MRI on initial evaluation and GFR at least 60 ml/min

Exclusion criteria

  • Neoadjuvant chemotherapy
  • Breast implants
  • Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)
  • Patients unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length
  • HER-2/neu positive
  • Positive serum pregnancy test

Treatment and study plan

Radiosurgery

Radiation

Single dose or radiation in 15Gy, 18Gy or 21Gy

Other names: External beam radiation therapy

Primary outcomes

  1. Maximum Tolerated Dose

    Time frame: 30 days

    As measured by the incidence of acute toxicity and wound healing complications

Secondary outcomes

  1. Cosmetic Outcome

    Time frame: 3 years

    Percent of patients with excellent or good cosmetic outcome at 3 years based on physician's assessment.

    EXCELLENT is defined as: when compared to the untreated breast or the original appearance of the treated breast, there is minimal or no difference in the size or shape of the treated breast. The way the breast feels (its texture) is the same or slightly different. There may be thickening, scar tissue, or seroma within the breast but not enough to change the appearance.

    GOOD is defined as: there is mild asymmetry between the breasts, which means that there is some acceptable difference in the size or shape of the treated breast as compared to the opposite breast or the appearance of the breast before treatment. There may be some mild reddening or darkening of the breast. The thickening or scar tissue within the breast causes a mild change in its shape or size.

  2. Local Control

    Time frame: 3 years

Other outcomes

  1. Acquire Tissue

    Time frame: Pre and post SRS radiosurgery

    Pre and post-radiotherapy for exploratory analysis of radiation response

  2. Magnetic Resonance Images(MRI)

    Time frame: Pre and post SRS radiosurgery

    Pre and post-radiotherapy for exploratory analysis of radiation response.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Single Dose Partial Breast Radiotherapy Using Extra-cranial Radiosurgery in Patients With Early Stage Breast Cancer - a Phase I Dose Escalation Study

Acronym: RSU

Important dates

Study start
2010
Primary completion
2016
Study completion
2023
First posted
Jul 23, 2009
Registry last updated
Oct 27, 2023

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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