Adjuvant Treatment Recommendation and Oncotype DX® in Early Breast Cancer

NCT01926964 | Completed

• 2 other identifiers: SAKK 26/1001-086
• Study Type: observational
• Target: 229
• Locations: 1 country
• Sites: 19

Brief Summary

Oncotype DX® is likely to become more widely used in Europe as well as in Switzerland. The test is currently not reimbursed by the Swiss health insurances. The proposed study will investigate to what extent adjuvant treatment recommendations in breast cancer patients with an ER-positive tumor, made by Swiss tumor boards, are based on conventional factors, and whether the recommendations would change, when RS results from the Oncotype DX® test were available. In addition this study approaches the dilemma of adding adjuvant CT to adjuvant endocrine therapy in a systematic fashion. In this study, the St. Gallen consensus 2009 (with a minor update from the 2011 consensus, is used to predefine the patients suitable for endocrine therapy or chemo-endocrine therapy. Once results of this study are available they may help to better integrate Oncotype DX® with other factors. Currently, it is unclear how the different factors should be integrated into one recommendation. This study will provide data on the usefulness of this test for the two patient groups which are suitable for hormone therapy only and for those who are considered for hormone plus chemotherapy.

Conditions

Breast Cancer

Keywords

Adjuvant treatment recommendation; Early breast cancer; Oncotype DX; Genetic profiling

Outcome Measures

Primary Outcomes (1)

• The decision change between the first and second tumor board adjuvant treatment recommendation

  1 month

Secondary Outcomes (2)

• The decision change between first and second shared decision about adjuvant treatment

  3 weeks

• The decision change between first shared decision and treatment actually given

  Between 1 and 3 months

Study Arms (1)

Early breast cancer patients

Patients with ER-positive, HER2 negative, pN0 or pN1a and resected primary breast cancer R0 resection.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ER-positive, HER2 negative, pN0 or pN1a and resected primary breast cancer R0 resection.

You may qualify if:

• \- 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.
• All patients matching the screening criteria should be recorded consecutively in the patient screening and enrollment list.
• Signed informed consent form for participation to the baseline data collection.
• In addition, the following information must be available from the pathology report:
• 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 Bloom-Richardson-Elston (BRE) Grading (Grade 1, 2 or 3).
• Signed informed consent form for participation to the study SAKK 26/10.
• The patient is considered suitable to receive adjuvant chemotherapy (ie no medical contraindications to chemotherapy).

You may not qualify if:

• Pregnancy
• Bilateral invasive breast cancer
• cT4 and pT4 tumors.
• Patient with a current psychiatric or medical diagnosis that would interfere with her ability to participate in this study.
• Known metastatic breast cancer (M1).

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (19)

Kantonsspital Baden

Baden, CH-5404, Switzerland

Location

Universitaetsspital-Basel

Basel, 4031, Switzerland

Location

Istituto Oncologico della Svizzera Italiana

Bellinzona, 6500, Switzerland

Location

Klinik Engeried / Praxis Oncocare

Bern, 3012, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Spitalzentrum Biel

Biel, CH-2501, Switzerland

Location

Kantonsspital Graubünden

Chur, 7000, Switzerland

Location

Kantonsspital Frauenfeld / Brustzentrum Thurgau

Frauenfeld, 8501, Switzerland

Location

Kantonsspital Freiburg

Fribourg, 1700, Switzerland

Location

Kantonsspital Liestal

Liestal, CH-4410, Switzerland

Location

Kantonsspital Luzern

Lucerne, 6000, Switzerland

Location

Kantonsspital Olten

Olten, 4600, Switzerland

Location

Tumorzentrum ZeTUP

Sankt Gallen, 9006, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

SpitalSTS AG Simmental-Thun-Saanenland

Thun, 3600, Switzerland

Location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

Brust-Zentrum Seefeld

Zurich, 8008, Switzerland

Location

Triemli Stadtspital / Frauenklinik

Zurich, 8063, Switzerland

Location

UniversitaetsSpital

Zurich, CH-8091, Switzerland

Location

Related Publications (1)

• Pestalozzi BC, Tausch C, Dedes KJ, Rochlitz C, Zimmermann S, von Moos R, Winterhalder R, Ruhstaller T, Mueller A, Buser K, Borner M, Novak U, Nussbaum CU, Seifert B, Bigler M, Bize V, Vilei SB, Rageth C, Aebi S; Swiss Group for Clinical Cancer Research (SAKK). Adjuvant treatment recommendations for patients with ER-positive/HER2-negative early breast cancer by Swiss tumor boards using the 21-gene recurrence score (SAKK 26/10). BMC Cancer. 2017 Apr 13;17(1):265. doi: 10.1186/s12885-017-3261-1.

  PMID: 28407750 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bernhard Pestalozzi, Prof

  University Hospital, Zürich

  STUDY CHAIR

• Stefan Aebi, Prof.

  Luzerner Kantonsspital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: August 21, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

CH (19)