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

Breast Cancer Clinical Trial

— PAPBI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024582
• Other study ID #: M08PBI
• Secondary ID: NL24996.031.08EU
• Status: Completed
• Phase: N/A
• First received: December 2, 2009
• Last updated: September 26, 2017
• Start date: October 2009
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

• image-guided radiation therapy

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local recurrence	Local recurrences should not exceed 4% at 5 years of follow-up	5 years
Secondary	breast fibrosis	decrease from 27% as found in the boost arm of the EORTC boost-no boost trial to 15%	5 years
Secondary	cosmetic outcome	is anticipated that the overall score for cosmetic outcome will be superior compared to conventional whole breast postoperative radiotherapy plus boost.	5 years
Secondary	Pathological response		6 weeks after finishing iradiation treatment