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Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer
This study is currently recruiting participants.
Verified by Washington University School of Medicine, February 2009
First Received: May 12, 2006   Last Updated: February 3, 2009   History of Changes
Sponsored by: Washington University School of Medicine
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00325598
  Purpose

This study investigates the feasibility and safety of delivering radiation therapy only to part of the breast, (the tumor bed and selected areas) rather than the whole breast, for patients with early stage breast cancer.


Condition Intervention Phase
Breast Neoplasms
Procedure: Partial Breast Irradiation
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer: A Phase I Feasibility Study

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • As a pilot study, the data analysis will be descriptive. An interim analysis for safety and effectiveness of treatment will be performed after the first 25 patients are enrolled [ Time Frame: Cosmetic outcome will be evaluated by the patient and the physician at the pretreatment consulation initial post-treatment visit, every 6 months for 5 years, then every year for at least another 5 years. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2006
Estimated Study Completion Date: February 2030
Estimated Primary Completion Date: February 2030 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Partial Breast Irradiation

    Group 1 (enrollment completed):

    Partial Breast Irradiation: 36 Gy in 9 fractions, given twice daily over 4.5 treatment days and a one week period.

    Group 2:

    Partial Breast Irradiation: 40 Gy in 10 fractions, given twice daily over 5 treatment days and a one week period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologic Documentation: Patients will have histologically confirmed Unicentric Stage I (T1 N0 M0) invasive ductal breast cancer. Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen. Tubular, mucinous and medullary variant histologies of infiltrating ductal carcinoma are permitted. Low-grade DCIS (I and II) of 2 cm or less with histologically negative margins of at least 2 mm margins (or a negative re-excision) are permitted. Women age 70 years or older with T1 invasive ductal carcinoma which are estrogen-receptor positive (ER+) with clinically negative axillary nodes who do not undergo surgical lymph node evaluation are also eligible if patient will take hormonal therapy. Patients with T1N0 (i+) tumors on sentinel lymph node mapping or dissection (i.e. is tumor deposit is 0.2mm or less, regardless of whether the deposit is detected by IHC or H&E staining) will also be eligible, provided that completion axillary dissection has been performed to confirm N0 status.
  2. Prior Treatment: Patient may have been treated with adjuvant chemotherapy. Patients may be on adjuvant hormonal therapy or begin hormonal therapy following XRT at the discretion of the medical oncologist.
  3. Radiation therapy should begin within:

    • 4-12 weeks from definitive surgical procedure
    • 2-6 weeks after chemotherapy, if chemotherapy given first
  4. Radiation cannot be delivered concurrently with chemotherapy.
  5. Age > 18 years of age
  6. ECOG Performance Status 0-2
  7. Required Initial Laboratory Data prior to the beginning of therapy: Granulocytes ≥1,500/µl; Platelet count ≥100,000/µl
  8. Signed informed consent.

Exclusion Criteria:

  1. Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5 cm of uninvolved tissue; alternatively, discontiguous tumors that are clinically or mammographically within separate breast quadrants or subareolar central region.
  2. Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region.
  3. Tumor > 2.0 cm, nodal involvement on H&E staining, or metastatic involvement
  4. Histological evidence of:

    1. Lymphovascular invasion: as defined by a tumor embolus present in an endothelial-lined space; cases with tumor emboli present in a space not lined by endothelial cells but otherwise very suspicious for an angiolymphatic space were also considered ineligible.
    2. EIC (Extensive Intraductal Component): defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumor area) and intraductal carcinoma present clearly beyond the edges of the invasive tumor, or as a predominantly intraductal tumor with one or more areas of focal invasion.
    3. Invasive Lobular Carcinoma
    4. Infiltrating carcinoma with mixed ductal and lobular features: cases with ambiguous or mixed histologic features that showed positive E-cadherin staining throughout the tumor by immunohistochemistry were classified as ductal type and considered eligible.
    5. Infiltrating papillary carcinoma
    6. Margins: In-situ or invasive carcinoma present less than 2 mm from the inked resection margin.
  5. History of cosmetic or reconstructive breast surgery
  6. Psychiatric illness which would prevent the patient from giving informed consent. Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or connective tissue diseases (lupus, systemic sclerosis or other collagen vascular diseases) which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
  7. Patients with a "currently active" second malignancy other than non-melanoma skin cancers.

    Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 5% risk of relapse within three years.

  8. Patients with diffuse (> 1 quadrant or > 5cm) suspicious microcalcifications
  9. Women who are pregnant.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325598

Contacts
Contact: Linda M. Brockman 314-454-7986 brockmal@ccadmin.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Simon N. Powell, M.D., Ph.D.            
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Imran Zoberi, M.D. Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine ( Simon Powell, M.D. )
Study ID Numbers: 05-1053
Study First Received: May 12, 2006
Last Updated: February 3, 2009
ClinicalTrials.gov Identifier: NCT00325598     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 01, 2009