Adjuvant Treatment Recommendation and Oncotype DX® in Early Breast Cancer

Breast Cancer Clinical Trial

Official title:

Impact of Recurrence Score® on Recommendations for Adjuvant Treatment in Patients With ER-positive Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926964
• Other study ID #: SAKK 26/10
• Secondary ID: 01-086
• Status: Completed
• Start date: September 2013
• Est. completion date: February 2015

Study information

• Verified date: May 2019
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients screening criteria

1. = 18 years old female patients.

2. Resected primary breast cancer (R0 resection).

3. ER-positive breast cancer (defined as at least 10% ER-positive malignant cells).

4. HER2 negativity by IHC (0 or 1+) or by FISH (negative if ratio is = 2.0).

5. 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.

Patients inclusion criteria for baseline data collection

1. Signed informed consent form for participation to the baseline data collection.

In addition, the following information must be available from the pathology report:

2. Estimation of the pathologic maximum tumor diameter (in mm).

3. Results of ER positive tumor cells (in %) and of PgR positive tumor cells (in %) of the invasive component.

4. Proliferation rate by Ki-67 staining (MIB-1 antibody) in %.

5. Result of modified Bloom-Richardson-Elston (BRE) Grading (Grade 1, 2 or 3).

Patients eligibility criteria for participation to the study Inclusion criteria

1. Signed informed consent form for participation to the study SAKK 26/10.

2. The patient is considered suitable to receive adjuvant chemotherapy (ie no medical contraindications to chemotherapy).

3. Invasive breast cancer tissue is available to prepare 39 sections (35 unstained + 4 H&E stained slides, thickness of 5 µm).

4. Performance Status: 0 or 1.

Exclusion criteria

1. Pregnancy

2. Bilateral invasive breast cancer

3. cT4 and pT4 tumors.

4. Patient with a current psychiatric or medical diagnosis that would interfere with her ability to participate in this study.

5. Known metastatic breast cancer (M1).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baden	Baden
Switzerland	Universitaetsspital-Basel	Basel
Switzerland	Istituto Oncologico della Svizzera Italiana	Bellinzona
Switzerland	Inselspital, Bern	Bern
Switzerland	Klinik Engeried / Praxis Oncocare	Bern
Switzerland	Spitalzentrum Biel	Biel
Switzerland	Kantonsspital Graubünden	Chur
Switzerland	Kantonsspital Frauenfeld / Brustzentrum Thurgau	Frauenfeld
Switzerland	Kantonsspital Freiburg	Fribourg
Switzerland	Kantonsspital Liestal	Liestal
Switzerland	Kantonsspital Luzern	Luzern
Switzerland	Kantonsspital Olten	Olten
Switzerland	Kantonsspital St. Gallen	St. Gallen
Switzerland	Tumorzentrum ZeTUP	St. Gallen
Switzerland	SpitalSTS AG Simmental-Thun-Saanenland	Thun
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	UniversitaetsSpital	Zurich
Switzerland	Brust-Zentrum Seefeld	Zürich
Switzerland	Triemli Stadtspital / Frauenklinik	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research

Country where clinical trial is conducted

Switzerland, 

References & 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 (S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The decision change between the first and second tumor board adjuvant treatment recommendation		1 month
Secondary	The decision change between first and second shared decision about adjuvant treatment		3 weeks
Secondary	The decision change between first shared decision and treatment actually given		Between 1 and 3 months