Clinical trial NCT01926964: Adjuvant Treatment Recommendation and Oncotype DX® in Early Breast Cancer
Official title: Impact of Recurrence Score® on Recommendations for Adjuvant Treatment in Patients With ER-positive Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Adjuvant treatment recommendation
Early breast cancer
Oncotype DX
Genetic profiling
Lead sponsor: Swiss Group for Clinical Cancer Research
Sponsor class: OTHER
First posted: 2013-08-21
Enrollment: 229
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ER-positive, HER2 negative, pN0 or pN1a and resected primary breast cancer R0 resection.

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.


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.

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).

Primary outcomes:
measure: The decision change between the first and second tumor board adjuvant treatment recommendation
timeFrame: 1 month
Secondary outcomes:
measure: The decision change between first and second shared decision about adjuvant treatment
timeFrame: 3 weeks
measure: The decision change between first shared decision and treatment actually given
timeFrame: Between 1 and 3 months
Other outcomes:
Locations:
city: Baden
country: Switzerland
facility: Kantonsspital Baden
city: Basel
country: Switzerland
facility: Universitaetsspital-Basel
city: Bellinzona
country: Switzerland
facility: Istituto Oncologico della Svizzera Italiana
city: Bern
country: Switzerland
facility: Klinik Engeried / Praxis Oncocare
city: Bern
country: Switzerland
facility: Inselspital, Bern
city: Biel
country: Switzerland
facility: Spitalzentrum Biel
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
city: Frauenfeld
country: Switzerland
facility: Kantonsspital Frauenfeld / Brustzentrum Thurgau
city: Fribourg
country: Switzerland
facility: Kantonsspital Freiburg
city: Liestal
country: Switzerland
facility: Kantonsspital Liestal
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
city: Olten
country: Switzerland
facility: Kantonsspital Olten
city: St. Gallen
country: Switzerland
facility: Tumorzentrum ZeTUP
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Thun
country: Switzerland
facility: SpitalSTS AG Simmental-Thun-Saanenland
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zurich
country: Switzerland
facility: UniversitaetsSpital
city: Zürich
country: Switzerland
facility: Brust-Zentrum Seefeld
city: Zürich
country: Switzerland
facility: Triemli Stadtspital / Frauenklinik
Study officials:
affiliation: University Hospital, Zürich
name: Bernhard Pestalozzi, Prof
role: STUDY_CHAIR
affiliation: Luzerner Kantonsspital
name: Stefan Aebi, Prof.
role: STUDY_CHAIR
References:
citation: 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.