Breast CancerNCT01926964
Adjuvant Treatment Recommendation and Oncotype DX® in Early Breast Cancer
An observational study of Breast Cancer, run by Swiss Cancer Institute at 19 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 229 participants
- Where
- 19 sitesSwitzerland
- Study dates
- Sep 2013to Feb 2015
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ER-positive, HER2 negative, pN0 or pN1a and resected primary breast cancer R0 resection.
Who may be able to join
- Patients screening criteria
- ≥ 18 years old female patients.
- Resected primary breast cancer (R0 resection).
- ER-positive breast cancer (defined as at least 10% ER-positive malignant cells).
- HER2 negativity by IHC (0 or 1+) or by FISH (negative if ratio is ≤ 2.0).
- pN0 or pN1a (1-3 positive nodes) by sentinel procedure or axillary dissection.
Show all 19Show fewer
- All patients matching the screening criteria should be recorded consecutively in the patient screening and enrollment list.
- Patients inclusion criteria for baseline data collection
- Signed informed consent form for participation to the baseline data collection.
- In addition, the following information must be available from the pathology report:
- Estimation of the pathologic maximum tumor diameter (in mm).
- Results of ER positive tumor cells (in %) and of PgR positive tumor cells (in %) of the invasive component.
- Proliferation rate by Ki-67 staining (MIB-1 antibody) in %.
- Result of modified Bloom-Richardson-Elston (BRE) Grading (Grade 1, 2 or 3).
- Patients eligibility criteria for participation to the study Inclusion criteria
- Signed informed consent form for participation to the study SAKK 26/10.
- The patient is considered suitable to receive adjuvant chemotherapy (ie no medical contraindications to chemotherapy).
- Invasive breast cancer tissue is available to prepare 39 sections (35 unstained + 4 H\&E stained slides, thickness of 5 µm).
- Performance Status: 0 or 1.
Who cannot join
- Pregnancy
- Bilateral invasive breast cancer
- cT4 and pT4 tumors.
- Patient with a current psychiatric or medical diagnosis that would interfere with her ability to participate in this study.
- Known metastatic breast cancer (M1).
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Switzerland19 sites
Kantonsspital Baden
Baden, CH-5404
Universitaetsspital-Basel
Basel, 4031
Istituto Oncologico della Svizzera Italiana
Bellinzona, 6500
Klinik Engeried / Praxis Oncocare
Bern, 3012
Inselspital, Bern
Bern, CH-3010
Spitalzentrum Biel
Biel, CH-2501
Kantonsspital Graubünden
Chur, 7000
Kantonsspital Frauenfeld / Brustzentrum Thurgau
Frauenfeld, 8501
Kantonsspital Freiburg
Fribourg, 1700
Kantonsspital Liestal
Liestal, CH-4410
Kantonsspital Luzern
Lucerne, 6000
Kantonsspital Olten
Olten, 4600
Tumorzentrum ZeTUP
Sankt Gallen, 9006
Kantonsspital St. Gallen
Sankt Gallen, 9007
SpitalSTS AG Simmental-Thun-Saanenland
Thun, 3600
Kantonsspital Winterthur
Winterthur, 8401
Brust-Zentrum Seefeld
Zurich, 8008
Triemli Stadtspital / Frauenklinik
Zurich, 8063
UniversitaetsSpital
Zurich, CH-8091
About this study
Official title: Impact of Recurrence Score® on Recommendations for Adjuvant Treatment in Patients With ER-positive Breast Cancer
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.
Read more
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.
- Conditions
- Breast Cancer
- Keywords
- Adjuvant treatment recommendation, Early breast cancer, Oncotype DX, Genetic profiling
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early breast cancer patients | Patients with ER-positive, HER2 negative, pN0 or pN1a and resected primary breast cancer R0 resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The decision change between the first and second tumor board adjuvant treatment recommendation
Measured: 1 month
Secondary outcomes (2)
The decision change between first and second shared decision about adjuvant treatment
Measured: 3 weeks
The decision change between first shared decision and treatment actually given
Measured: Between 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 229 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernhard Pestalozzi, Prof, Study chair, University Hospital, ZürichStefan Aebi, Prof., Study chair, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926964
- Sponsor's protocol ID
- SAKK 26/10
- Other IDs
- 01-086
- Status last verified
- May 2019
- First submitted
- 19 Aug 2013
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28407750
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Recurrence Score® on Recommendations for Adjuvant Treatment in Patients With ER-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT01926964
- Acronym / sponsor ID
- SAKK 26/10
- Conditions
- Breast Cancer
- Keywords
- Adjuvant treatment recommendation, Early breast cancer, Oncotype DX, Genetic profiling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early breast cancer patients | – | –Patients with ER-positive, HER2 negative, pN0 or pN1a and resected primary breast cancer R0 resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ER-positive, HER2 negative, pN0 or pN1a and resected primary breast cancer R0 resection.
Key inclusion criteria (19 listed)
- Patients screening criteria
- ≥ 18 years old female patients.
- Resected primary breast cancer (R0 resection).
- ER-positive breast cancer (defined as at least 10% ER-positive malignant cells).
- HER2 negativity by IHC (0 or 1+) or by FISH (negative if ratio is ≤ 2.0).
Key exclusion criteria (5 listed)
- Pregnancy
- Bilateral invasive breast cancer
- cT4 and pT4 tumors.
- Patient with a current psychiatric or medical diagnosis that would interfere with her ability to participate in this study.
- Known metastatic breast cancer (M1).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The decision change between the first and second tumor board adjuvant treatment recommendation
Time frame: 1 month
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Results publication: PubMed 28407750Pestalozzi 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.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Pestalozzi, Prof study chair
University Hospital, Zürich
Stefan Aebi, Prof. study chair
Luzerner Kantonsspital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Swiss Cancer Institute at 19 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The decision change between the first and second tumor board adjuvant treatment recommendation (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01926964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.