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

Netherlands Cancer Institute (NKI)

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: biopsy; Radiation: image-guided radiation therapy; Radiation: accelerated partial breast irradiation; Procedure: fine-needle aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT01024582

EU-20989

NL24996.031.08 (Registry Identifier)

M08PBI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 139 patients

Sex: All

Ages: 60 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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139 participants in 1 patient group

accelerated partial breast irradiation

Experimental group

Description:

pre-operative radiation of the in situ tumor in the breast

Treatment:

Radiation: accelerated partial breast irradiation

Procedure: fine-needle aspiration

Radiation: image-guided radiation therapy

Procedure: biopsy