Clinical trial NCT01024582: Radiation Therapy Followed by Surgery in Treating Patients With Early-Stage Breast Cancer
Official title: Image Guided Preoperative Accelerated Partial Breast Irradiation (PAPBI): Defining Radiotherapy Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
invasive breast cancer
adenocarcinoma of the breast
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2009-12-03
Enrollment: 139
Sex: ALL
Minimum age (years): 60
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: local recurrence
timeFrame: 5 years
Secondary outcomes:
measure: breast fibrosis
timeFrame: 5 years
measure: cosmetic outcome
timeFrame: 5 years
measure: Pathological response
timeFrame: 6 weeks after finishing iradiation treatment
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Study officials:
affiliation: The Netherlands Cancer Institute
name: Paula Elkhuizen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.