Download study overview sakk 26/10 - Swiss Group for Clinical Cancer Research

STUDY OVERVIEW SAKK 26/10
SAKK 26/10. Impact of Recurrence Score® on Recommendations for Adjuvant Treatment in
Patients with ER-positive Breast Cancer.
OBJECTIVES
Study objectives:
The objective of the study is to test whether Oncotype DX® Recurrence score® (RS) leads to a
relevant proportion of changes of treatment recommendation made by a multidisciplinary Swiss
tumor board.
ENDPOINTS
TRIAL DESIGN
Multicenter, prospective, cohort study.
SELECTION OF PATIENTS
Patients screening criteria
 ≥ 18 years old female patients.
 Resected primary breast cancer (R0 resection).
 ER-positive breast cancer (defined as at least 10% ER-positive malignant cells).
 HER2 negativity by IHC (0 or 1+) or by FISH (negative if ratio is ≤ 2.0).
 pN0 or pN1a (1-3 positive nodes) by sentinel procedure or axillary dissection.
Patients inclusion criteria for baseline data collection
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Signed informed consent form for participation to the baseline data collection.
Estimation of the pathologic maximum tumor diameter (in mm).
Results of ER positive tumor cells (in %) and of PgR positive tumor cells (in %) of the invasive
component.
Proliferation rate by Ki-67 staining (MIB-1 antibody) in %.
Result of modified BRE Grading (Grade 1, 2 or 3).
Patients eligibility criteria for participation to the study
Inclusion criteria
 Signed informed consent form for participation to the study SAKK 26/10.
 The patient is considered suitable to receive adjuvant chemotherapy.
 Invasive breast cancer tissue is available to prepare 39 sections (thickness of 5 µm).
 WHO performance Status: 0 or 1.
Exclusion criteria
 Pregnancy
 Bilateral invasive breast cancer
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cT4 and pT4 tumors.
Patient with a current psychiatric or medical diagnosis that would interfere with her ability to
participate in the study.
Known metastatic breast cancer (M1).
STUDY DURATION
The inclusion of patients is planned to start in Q2 2013 and will stop after the inclusion of 175
patients, which is expected in Q1 2015. End of the study (last patient, last visit) is expected for Q2
2015. There will be no follow-up of the participating patients.
STATISTICAL CONSIDERATIONS
The calculated sample size is 175 patients, incorporating potential non evaluable patients (10%).