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Trial record 1 of 1 for:    SAKK 26/10
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Adjuvant Treatment Recommendation and Oncotype DX® in Early Breast Cancer

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ClinicalTrials.gov Identifier: NCT01926964
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : May 15, 2019
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

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.

Condition or disease
Breast Cancer

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Study Type : Observational [Patient Registry]
Actual Enrollment : 229 participants
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
Study Start Date : September 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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

Primary Outcome Measures :
  1. The decision change between the first and second tumor board adjuvant treatment recommendation [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. The decision change between first and second shared decision about adjuvant treatment [ Time Frame: 3 weeks ]
  2. The decision change between first shared decision and treatment actually given [ Time Frame: Between 1 and 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926964

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Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
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Study Chair: Bernhard Pestalozzi, Prof University Hospital, Zürich
Study Chair: Stefan Aebi, Prof. Luzerner Kantonsspital
Additional Information:

Publications of Results:
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Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT01926964    
Other Study ID Numbers: SAKK 26/10
01-086 ( Other Identifier: Genomic Health Inc. )
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Keywords provided by Swiss Group for Clinical Cancer Research:
Adjuvant treatment recommendation
Early breast cancer
Oncotype DX
Genetic profiling
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases