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NCT Number: NCT02400658

Efficacy of IORT With CT-Guided HDR Brachytherapy for Treatment of Breast Cancer

The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat early-stage breast cancer at the time of surgery.

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This study is active but is not currently recruiting participants.

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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

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hackensack Meridian Health - John Theurer Cancer Center, Hackensack, New Jersey, United States

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About this study

This is a prospective single-arm phase II study designed to study the efficacy of high dose rate (HDR) brachytherapy with CT-imaging, single-fraction intraoperative radiation therapy (IORT). The study will accrue patients with early-stage breast cancer who will be treated with breast-conserving surgery (BCS). The main clinical eligibility criterion is based on suitability for accelerated partial breast irradiation. Patients may be eligible prior to receiving BCS or within 30 days of receiving BCS. Eligible patients that will undergo BCS will receive surgery according to the standard clinical practice in the Brachytherapy Suite in the Emily Couric Clinical Cancer Center. Patients that have already undergone BCS must meet all other eligibility criteria and are able to be treated with IORT within 30 days of their breast surgery. Eligible subjects will undergo a lumpectomy or re-excision lumpectomy according the standard clinical practice. Immediately following lumpectomy, the breast HDR brachytherapy applicator will be placed and CT imaging will be performed for treatment planning. After HDR brachytherapy is delivered, the applicator will be removed, and the breast surgeon will complete the skin closure. Although the ultimate goal of the study is to determine 5-year ipsilateral breast tumor recurrence (IBTR), all efforts will be made to follow the patients until death.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient has elected breast conserving surgery or whole breast irradiation treatment for early-stage breast cancer.
  • Tumor size must be less than or equal to 3 cm.
  • Patient is 45 years of age or older.

Exclusion criteria

  • Male patients.
  • Pregnant patients.
  • Breast cancer that involves the skin or chest wall.
  • History of ipsilateral breast cancer.
  • Multicentric breast cancer in the ipsilateral breast.
  • Known BRCA gene mutation.
  • Patient with nodal disease.
  • Patient is undergoing initial medical treatment (hormone or chemotherapy) to reduce tumor size.
  • Patient with breast implants (does not include patients having implants AFTER intra-operative radiotherapy).

Treatment and study plan

IORT with CT-Guided HDR Brachytherapy

Device

This therapy targets the cancer cells directly, reducing the volume of breast tissue exposed to the radiation and the risks involved with the radiation. CT imaging will be used via a multichannel/multi-dwell balloon catheter to better sculpt the cancer away from the heart, skin, and ribs.

Other names: Surgery, Breast Lumpectomy

Primary outcomes

  1. Rate of Local Breast Tumor Recurrence

    Time frame: Up to 60 Months After Treatment

Secondary outcomes

  1. Rate of Ipsilateral Breast Tumor (Not Local) Recurrence

    Time frame: Up to 60 Months After Treatment

  2. Rate of Distant Recurrence of Breast Cancer

    Time frame: Up to 60 Months After Treatment

  3. Cancer Specific-Survival and Overall Survival Response Rate

    Time frame: Minimum of 60 Months After Treatment

  4. Changes in Reported Patient and Physician Cosmetic Descriptions

    Time frame: Up to 60 Months After Treatment

  5. Comparison of Pre-and Post Pathology Stratum

    Time frame: Up to 60 Months After Treatment

  6. Changes in Patient-Reported Quality of Life

    Time frame: Up to 60 Months After Treatment

  7. Number of Participants with Adverse Events

    Time frame: 24 Months After Treatment

    Safety and toxicity of treatment will be determined with the Common Toxicity Criteria for Adverse Effects.

  8. Changes of Radiographic Breast Appearance

    Time frame: Up to 60 Months After Treatment

Sponsors and collaborators

Lead sponsor

Shayna Showalter, MD

Other

Registry information

Official study title

A Prospective Single-Arm Phase II Study To Investigate The Efficacy Of Single-Fraction Intraoperative Radiation Treatment Using A Multi-Lumen Balloon Applicator And In-Room CT Imaging For The Treatment Of Early-Stage Breast Cancer

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2015
Registry last updated
Jan 25, 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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