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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01024582
Acronym
PAPBI
Enrollment
139
Registered
2009-12-03
Start date
2009-10-31
Completion date
2017-02-28
Last updated
2017-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, invasive breast cancer, adenocarcinoma of the breast

Brief summary

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.

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.

Interventions

PROCEDUREbiopsy

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

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

RADIATIONaccelerated partial breast irradiation

Sponsors

The Netherlands Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
local recurrence5 yearsLocal recurrences should not exceed 4% at 5 years of follow-up

Secondary

MeasureTime frameDescription
breast fibrosis5 yearsdecrease from 27% as found in the boost arm of the EORTC boost-no boost trial to 15%
cosmetic outcome5 yearsis anticipated that the overall score for cosmetic outcome will be superior compared to conventional whole breast postoperative radiotherapy plus boost.
Pathological response6 weeks after finishing iradiation treatment

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026