Adjuvant Treatment Recommendation and Oncotype DX® in Early Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT01926964
First received: August 19, 2013
Last updated: May 26, 2014
Last verified: May 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 ]

Enrollment: 217
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926964

Locations
Switzerland
Kantonsspital Baden
Baden, Switzerland, CH-5404
Universitaetsspital-Basel
Basel, Switzerland, 4031
Istituto Oncologico della Svizzera Italiana
Bellinzona, Switzerland, 6500
Klinik Engeried / Praxis Oncocare
Bern, Switzerland, 3012
Inselspital, Bern
Bern, Switzerland, CH-3010
Spitalzentrum Biel
Biel, Switzerland, CH-2501
Kantonsspital Graubünden
Chur, Switzerland, 7000
Kantonsspital Frauenfeld / Brustzentrum Thurgau
Frauenfeld, Switzerland, 8501
Kantonsspital Freiburg
Fribourg, Switzerland, 1700
Kantonsspital Liestal
Liestal, Switzerland, CH-4410
Kantonsspital Luzern
Luzern, Switzerland, 6000
Kantonsspital Olten
Olten, Switzerland, 4600
Tumorzentrum ZeTUP
St. Gallen, Switzerland, 9006
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
SpitalSTS AG Simmental-Thun-Saanenland
Thun, Switzerland, 3600
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
UniversitaetsSpital
Zurich, Switzerland, CH-8091
Brust-Zentrum Seefeld
Zürich, Switzerland, 8008
Triemli Stadtspital / Frauenklinik
Zürich, Switzerland, 8063
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: May 26, 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 August 21, 2014