Radiation Therapy Followed by Surgery in Treating Patients With Early-Stage Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2009 by National Cancer Institute (NCI)
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01024582
First received: December 2, 2009
Last updated: August 9, 2013
Last verified: December 2009
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving CT-guided accelerated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This clinical trial is studying giving radiation therapy followed by surgery to see how well it works in treating patients with early-stage breast cancer.


Condition Intervention
Breast Cancer
Genetic: DNA analysis
Genetic: RNA analysis
Genetic: gene expression analysis
Other: laboratory biomarker analysis
Procedure: biopsy
Procedure: fine-needle aspiration
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: accelerated partial breast irradiation
Radiation: image-guided radiation therapy

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Image Guided Preoperative Accelerated Partial Breast Irradiation (PAPBI): Defining Radiotherapy Sensitivity

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Gene expression profile that predicts breast cancer radiosensitivity [ Designated as safety issue: No ]
  • Optimal treatment strategies [ Designated as safety issue: No ]
  • Comparison of radio-induced genetic alterations on the surgical post-radiation specimen with tumor response 6 weeks after the end of radiotherapy [ Designated as safety issue: No ]
  • Early changes in gene profiling [ Designated as safety issue: No ]
  • Early functional-imaging modifications [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2009
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To develop a gene expression profile that predicts the breast cancer radiosensitivity in patients with early-stage breast cancer treated with neoadjuvant image-guided preoperative accelerated partial-breast irradiation followed by surgery.
  • To further design optimal treatment strategies for individual breast cancer patients treated with breast-conserving therapy (BCT).
  • To assess the radio-induced genetic alterations on the surgical post-radiation specimen compared to the tumor response 6 weeks after the end of radiotherapy.
  • To study the early changes in gene profiling.
  • To evaluate the early functional-imaging modifications.

OUTLINE: Patients undergo image-guided preoperative accelerated partial-breast irradiation (PAPBI) 10 times over 12 days (using cone-beam CT linear accelerator for accurate tumor delineation and control of accurate radiation-dose delivery to the tumor). Beginning 6 weeks after completion of image-guided PAPBI, patients undergo surgery.

Patients undergo biopsy and fine-needle aspiration prior to and during radiotherapy and at the time of surgery. Gene expression profiling from RNA and DNA isolated from these samples are used to identify breast cancer radiosensitivity. biopsies and fine needle aspiration taken of the tumor before, during radiotherapy and at time of operation. The mRNA gene expression profiles, the miRNA expression profiles and the DNA copy number changes are correlated with response to radiotherapy (defined as pathologic response at the time of the lumpectomy [i.e. 6 weeks after the completion of the PAPBI]).

Fresh-frozen tumor tissue, blood, and urine samples are also collected to assess the radio-induced genetic alterations; to study the early changes in gene profiling; and to evaluate the early functional-imaging modifications.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of unifocal cT1-2 (1-3 cm) pN0 M0 breast cancer
  • Must have undergone a sentinel node procedure prior to irradiation

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024582

Locations
Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital Recruiting
Amsterdam, Netherlands, 1066 BE
Contact: Contact Person    31-20-512-1714    p.elkhuizen@nki.nl   
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
Principal Investigator: Paula Elkhuizen, MD The Netherlands Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01024582     History of Changes
Other Study ID Numbers: CDR0000660324, CDR0000660324, EU-20989
Study First Received: December 2, 2009
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
male breast cancer

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

ClinicalTrials.gov processed this record on July 28, 2014