Adjuvant Treatment Recommendation and Oncotype DX® in Early Breast Cancer

NCT ID: NCT01926964

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 229 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-02-28

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Early breast cancer patients

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

No interventions assigned to this group

Eligibility Criteria

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.

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).

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Swiss Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernhard Pestalozzi, Prof

Role: STUDY_CHAIR

University Hospital, Zürich

Stefan Aebi, Prof.

Role: STUDY_CHAIR

Luzerner Kantonsspital

Locations

Kantonsspital Baden

Baden, , Switzerland

Universitaetsspital-Basel

Basel, , Switzerland

Istituto Oncologico della Svizzera Italiana

Bellinzona, , Switzerland

Klinik Engeried / Praxis Oncocare

Bern, , Switzerland

Inselspital, Bern

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

Lucerne, , Switzerland

Kantonsspital Olten

Olten, , Switzerland

Tumorzentrum ZeTUP

Sankt Gallen, , Switzerland

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

SpitalSTS AG Simmental-Thun-Saanenland

Thun, , Switzerland

Kantonsspital Winterthur

Winterthur, , Switzerland

Brust-Zentrum Seefeld

Zurich, , Switzerland

Triemli Stadtspital / Frauenklinik

Zurich, , Switzerland

UniversitaetsSpital

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: RESULT

PMID: 28407750 (View on PubMed)

Other Identifiers

01-086

Identifier Type: OTHER

Identifier Source: secondary_id

SAKK 26/10

Identifier Type: -

Identifier Source: org_study_id