Adjuvant Treatment Recommendation and Oncotype DX® in Early Breast Cancer

This study is currently recruiting participants.
Verified March 2014 by Swiss Group for Clinical Cancer Research
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT01926964
First received: August 19, 2013
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Weeks
Official Title: Impact of Recurrence Score® on Recommendations for Adjuvant Treatment in Patients With ER-positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • The decision change between the first and second tumor board adjuvant treatment recommendation [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The decision change between first and second shared decision about adjuvant treatment [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • The decision change between first shared decision and treatment actually given [ Time Frame: Between 1 and 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 175
Study Start Date: September 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Early breast cancer patients
Patients with ER-positive, HER2 negative, pN0 or pN1a and resected primary breast cancer R0 resection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01926964

Contacts
Contact: Vincent Bize, PhD +41 31 389 94 65 vincent.bize@sakk.ch

Locations
Switzerland
Kantonsspital Baden Recruiting
Baden, Switzerland, CH-5404
Contact: Ziad Atassi, MD    +41 56 486 35 12    ziad.atassi@ksb.ch   
Principal Investigator: Ziad Atassi, MD         
Universitaetsspital-Basel Recruiting
Basel, Switzerland, 4031
Contact: Christoph Rochlitz, Prof    +41 61 265 50 74    crochlitz@uhbs.ch   
Principal Investigator: Christoph Rochlitz, Prof         
Istituto Oncologico della Svizzera Italiana Recruiting
Bellinzona, Switzerland, 6500
Contact: Olivia Pagani, MD    +41 91 811 84 35    olivia.pagani@ibcsg.org   
Principal Investigator: Olivia Pagani, MD         
Klinik Engeried / Praxis Oncocare Recruiting
Bern, Switzerland, 3012
Contact: Katharina Buser, MD    +41 31 309 95 01    kbuser@oncocare.ch   
Principal Investigator: Katharina Buser, MD         
Inselspital, Bern Recruiting
Bern, Switzerland, CH-3010
Contact: Urban Novak, MD    +41 31 632 19 92    urban.novak@insel.ch   
Principal Investigator: Urban Novak, MD         
Spitalzentrum Biel Recruiting
Biel, Switzerland, CH-2501
Contact: Markus Borner, Prof.    +41 32 324 37 14    markus.borner@szb-chb.ch   
Principal Investigator: Markus Borner, Prof         
Kantonsspital Graubünden Recruiting
Chur, Switzerland, 7000
Contact: Roger von Moos, MD, PD    +41 81 256 66 47    roger.vonmoos@ksgr.ch   
Principal Investigator: Roger von Moos, MD, PD         
Kantonsspital Frauenfeld / Brustzentrum Thurgau Recruiting
Frauenfeld, Switzerland, 8501
Contact: Mathias Fehr, MD    +41 52 723 72 53    mathias.fehr@stgag.ch   
Principal Investigator: Mathias Fehr, MD         
Kantonsspital Freiburg Recruiting
Fribourg, Switzerland, 1700
Contact: Daniel Betticher, Prof.    +41 26 426 72 40    betticherd@h-fr.ch   
Principal Investigator: Daniel Betticher, Prof.         
Kantonsspital Liestal Recruiting
Liestal, Switzerland, CH-4410
Contact: Andreas Lohri, Prof    41-61-925-2710    andreas.lohri@ksli.ch   
Principal Investigator: Andreas Lohri, Prof         
Kantonsspital Luzern Recruiting
Luzern, Switzerland, 6000
Contact: Ralph Winterhalder, MD    +41 41 205 58 75    ralph.winterhalder@ksl.ch   
Principal Investigator: Ralph Winterhalder, MD         
Kantonsspital Olten Recruiting
Olten, Switzerland, 4600
Contact: Catrina Uhlmann Nussbaum, MD    +41 62 311 42 41    cuhlmann_ol@spital.ktso.ch   
Principal Investigator: Catrina Uhlmann Nussbaum, MD         
Tumorzentrum ZeTUP Recruiting
St. Gallen, Switzerland, 9006
Contact: Friedemann Honecker, MD    +41 71 243 00 43    friedemann.honecker@zetup.ch   
Principal Investigator: Friedemann Honecker, MD         
Kantonsspital St. Gallen Recruiting
St. Gallen, Switzerland, 9007
Contact: Thomas Ruhstaller, MD    +41 71 494 20 82    thomas.ruhstaller@kssg.ch   
Principal Investigator: Thomas Ruhstaller, MD         
SpitalSTS AG Simmental-Thun-Saanenland Recruiting
Thun, Switzerland, 3600
Contact: Daniel Rauch    +41 33 226 26 45    daniel.rauch@spitalstsag.ch   
Principal Investigator: Daniel Rauch, MD         
Kantonsspital Winterthur Recruiting
Winterthur, Switzerland, 8401
Contact: Andreas Müller, MD    +41 52 266 25 52    andreas.mueller@ksw.ch   
Principal Investigator: Andreas Müller, MD         
UniversitaetsSpital Recruiting
Zurich, Switzerland, CH-8091
Contact: Cornelia Leo, MD    +41 44 255 51 50    cornelia.leo@usz.ch   
Principal Investigator: Cornelia Leo, MD         
Brust-Zentrum Seefeld Recruiting
Zürich, Switzerland, 8008
Contact: Christoph Tausch, MD    +41 44 380 76 60    c.tausch@brust-zentrum.ch   
Principal Investigator: Christoph Tausch, MD         
Triemli Stadtspital / Frauenklinik Recruiting
Zürich, Switzerland, 8063
Contact: Heike Passmann-Kegel, MD    +41 44 466 54 15    heike.passmann@triemli.stzh.ch   
Principal Investigator: Heike Passmann-Kegel, MD         
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Bernhard Pestalozzi, Prof University Hospital, Zürich
Study Chair: Stefan Aebi, Prof. Luzerner Kantonsspital
  More Information

No publications provided

Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT01926964     History of Changes
Other Study ID Numbers: SAKK 26/10, 01-086
Study First Received: August 19, 2013
Last Updated: March 17, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Swiss Group for Clinical Cancer Research:
Adjuvant treatment recommendation
Early breast cancer
Oncotype DX
Genetic profiling

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 22, 2014