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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by The Netherlands Cancer Institute
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT01024582
First received: December 2, 2009
Last updated: February 4, 2016
Last verified: December 2015
  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
Procedure: biopsy
Procedure: fine-needle aspiration
Radiation: accelerated partial breast irradiation
Radiation: image-guided radiation therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
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 The Netherlands Cancer Institute:

Primary Outcome Measures:
  • local recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Local recurrences should not exceed 4% at 5 years of follow-up


Secondary Outcome Measures:
  • breast fibrosis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    decrease from 27% as found in the boost arm of the EORTC boost-no boost trial to 15%

  • cosmetic outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    is anticipated that the overall score for cosmetic outcome will be superior compared to conventional whole breast postoperative radiotherapy plus boost.

  • Pathological response [ Time Frame: 6 weeks after finishing iradiation treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: October 2009
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: accelerated partial breast irradiation
pre-operative radiation of the in situ tumor in the breast
Procedure: biopsy
before treatment a biopsy will be taken to confirm breast cancer type
Procedure: fine-needle aspiration
at FNA tumor material will be collected and fresh frozen for micro-analyses; parafin embedded tissue will bestored for tissue-array analysis
Radiation: accelerated partial breast irradiation Radiation: image-guided radiation therapy

Detailed Description:

OBJECTIVES:

  • is to investigate the impact of a short fractionated schedule given preoperatively on local control, cosmesis and breast fibrosis.
  • To further design optimal treatment strategies for individual breast cancer patients treated with breast-conserving therapy (BCT) on the basis of biological parameters, including the expression profile of the primary tumor, for both m-RNA as for micro-RNA, with first, a focus on radiotherapy responsiveness and second, on local recurrence rate, distant metastases and survival.
  • proteomics will be studied in fine-needle aspiration samples. A classifier can be build (genomic or proteomic or any kind of molecular signature) to identify responders and non-responders
  • quality of life

OUTLINE: Patients undergo image-guided preoperative accelerated partial-breast irradiation (PAPBI) 10 times over 12 days (10 x 4 Gy) and later in the study 5 times 6 Gy. Six weeks after completion of image-guided PAPBI, patients undergo surgery.

  Eligibility

Ages Eligible for Study:   60 Years to 120 Years
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT01024582     History of Changes
Other Study ID Numbers: M08PBI  NL24996.031.08  EU-20989 
Study First Received: December 2, 2009
Last Updated: February 4, 2016
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by The Netherlands Cancer Institute:
breast cancer
invasive breast cancer
adenocarcinoma of the breast

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

ClinicalTrials.gov processed this record on April 27, 2016