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

• ClinicalTrials.gov Identifier: NCT01024582
• Recruitment Status: Completed
• First Posted: December 3, 2009
• Last Update Posted: September 27, 2017
• Sponsor: The Netherlands Cancer Institute
• Information provided by (Responsible Party): The Netherlands Cancer Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Procedure: biopsy; Procedure: fine-needle aspiration; Radiation: accelerated partial breast irradiation; Radiation: image-guided radiation therapy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 139 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Image Guided Preoperative Accelerated Partial Breast Irradiation (PAPBI): Defining Radiotherapy Sensitivity
• Study Start Date: October 2009
• Actual Primary Completion Date: February 2017
• Actual Study Completion Date: February 2017

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. local recurrence [ Time Frame: 5 years ]
   Local recurrences should not exceed 4% at 5 years of follow-up

Secondary Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 120 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Netherlands

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, Netherlands, 1066 BE

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):

van der Leij F, Bosma SC, van de Vijver MJ, Wesseling J, Vreeswijk S, Rivera S, Bourgier C, Garbay JR, Foukakis T, Lekberg T, van den Bongard DH, van Vliet-Vroegindeweij C, Bartelink H, Rutgers EJ, Elkhuizen PH. First results of the preoperative accelerated partial breast irradiation (PAPBI) trial. Radiother Oncol. 2015 Mar;114(3):322-7. doi: 10.1016/j.radonc.2015.02.002. Epub 2015 Feb 17.

• Responsible Party: The Netherlands Cancer Institute
• ClinicalTrials.gov Identifier: NCT01024582
• Other Study ID Numbers: M08PBI; NL24996.031.08 ( Registry Identifier: CCMO ); EU-20989
• First Posted: December 3, 2009
• Last Update Posted: September 27, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by The Netherlands Cancer Institute:

breast cancer; invasive breast cancer; adenocarcinoma of the breast

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases