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Completed

NCT Number: NCT01024582

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

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.

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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

60 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 BE, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Biopsy

Procedure

before treatment a biopsy will be taken to confirm breast cancer type

Fine-Needle Aspiration

Procedure

at FNA tumor material will be collected and fresh frozen for micro-analyses; parafin embedded tissue will bestored for tissue-array analysis

Accelerated Partial Breast Irradiation

Radiation

image-guided radiation therapy

Radiation

Primary outcomes

  1. local recurrence

    Time frame: 5 years

    Local recurrences should not exceed 4% at 5 years of follow-up

Secondary outcomes

  1. breast fibrosis

    Time frame: 5 years

    decrease from 27% as found in the boost arm of the EORTC boost-no boost trial to 15%

  2. cosmetic outcome

    Time frame: 5 years

    is anticipated that the overall score for cosmetic outcome will be superior compared to conventional whole breast postoperative radiotherapy plus boost.

  3. Pathological response

    Time frame: 6 weeks after finishing iradiation treatment

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

Image Guided Preoperative Accelerated Partial Breast Irradiation (PAPBI): Defining Radiotherapy Sensitivity

Acronym: PAPBI

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2009
Registry last updated
Sep 27, 2017

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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