Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    SAKK 26/10
Previous Study | Return to List | Next Study

Adjuvant Treatment Recommendation and Oncotype DX® in Early Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01926964
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Tracking Information
First Submitted Date August 19, 2013
First Posted Date August 21, 2013
Last Update Posted Date May 15, 2019
Study Start Date September 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 19, 2013)
The decision change between the first and second tumor board adjuvant treatment recommendation [ Time Frame: 1 month ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 19, 2013)
  • The decision change between first and second shared decision about adjuvant treatment [ Time Frame: 3 weeks ]
  • The decision change between first shared decision and treatment actually given [ Time Frame: Between 1 and 3 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 3 Weeks
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with ER-positive, HER2 negative, pN0 or pN1a and resected primary breast cancer R0 resection.
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Early breast cancer patients
Patients with ER-positive, HER2 negative, pN0 or pN1a and resected primary breast cancer R0 resection.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 8, 2014)
229
Original Estimated Enrollment
 (submitted: August 19, 2013)
175
Actual Study Completion Date February 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
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).
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01926964
Other Study ID Numbers SAKK 26/10
01-086 ( Other Identifier: Genomic Health Inc. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Swiss Group for Clinical Cancer Research
Study Sponsor Swiss Group for Clinical Cancer Research
Collaborators Not Provided
Investigators
Study Chair: Bernhard Pestalozzi, Prof University Hospital, Zürich
Study Chair: Stefan Aebi, Prof. Luzerner Kantonsspital
PRS Account Swiss Group for Clinical Cancer Research
Verification Date May 2019