A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer (ONCOTYPEDX)
26 mars 2014 uppdaterad av: Ontario Clinical Oncology Group (OCOG)
A prospective population-based cohort study is being conducted in Ontario to evaluate whether the performance of Oncotype DX® changes the treatment recommended and the treatment received in women or men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy and who are candidates for chemotherapy.
One thousand eligible consenting women and men will have their tumor tissue specimen sent to Genomic Health where the Oncotype DX® assay will be performed.
Studieöversikt
Detaljerad beskrivning
The evidence supporting the adoption of Oncotype DX® is relatively weak by the criteria used by the Ontario Health Technology Advisory Committee (OHTAC).
There is only one small published prospective study that reports on Oncotype DX® changing clinical management.
The economic models that estimated the potential advantages of using an Oncotype DX® guided treatment strategy may have overestimated the benefits because they assumed that all patients with tumors >1cm in the absence of Oncotype DX® testing would receive chemotherapy in addition to tamoxifen, and that the magnitude of benefit with chemotherapy over tamoxifen is relatively large, i.e. reduces recurrence risk by 74% and associated with an absolute benefit of 28%.
(The benefit comes from one trial and is applied to all patients).
It is estimated that there are about 3,300 incident cases with node negative, ER positive, HER2 neu negative tumors annually in Ontario, it is important to evaluate the adoption of this test for decision making in Ontario.
Studietyp
Interventionell
Inskrivning (Faktisk)
1011
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ontario
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Barrie, Ontario, Kanada, L4M 6M2
- Simcoe Muskoka Cancer Program - Royal Victoria Hospital
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Belleville, Ontario, Kanada, K8N 5A9
- Quinte Healthcare Corporation
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Brampton, Ontario, Kanada, L6R 3J7
- William Osler Health Centre
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Brantford, Ontario, Kanada, N3R 1G9
- Brantford General Hospital
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Burlington, Ontario, Kanada, L7S 1W7
- Joseph Brant Hospital
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Cambridge, Ontario, Kanada, N1R 3G2
- Cambridge Memorial Hospital
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Hamilton, Ontario, Kanada, L8V 1C3
- Juravinski Cancer Centre
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Kingston, Ontario, Kanada, K7L 5P9
- Cancer Centre of Southeastern Ontario at Kingston
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Kitchener, Ontario, Kanada, N2G 1G3
- Grand River Regional Cancer Centre
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London, Ontario, Kanada, N6A 4L6
- London Regional Cancer Centre
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Markham, Ontario, Kanada, L6B 1A1
- Markham Stouffville Hospital
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Mississauga, Ontario, Kanada, L5M 2N1
- The Credit Valley Hospital
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Newmarket, Ontario, Kanada, L3Y 2P9
- Stronach Regional Cancer Centre
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Oshawa, Ontario, Kanada, L1G 2B9
- R.S. McLaughlin Durham Regional Cancer Centre - Lakeridge Health
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Ottawa, Ontario, Kanada, K1H 8L6
- The Ottawa Hospital Regional Cancer Centre
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Owen Sound, Ontario, Kanada, N4K 6M9
- Grey Bruce Health Services
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Peterborough, Ontario, Kanada, K9J 7C6
- Peterborough Regional Health Centre
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Richmond Hill, Ontario, Kanada, L4C 4Z3
- Mackenzie Health
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Sarnia, Ontario, Kanada, N7T 6S3
- Bluewater Health
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Sault Ste. Marie, Ontario, Kanada, P6B 0A8
- Algoma District Cancer Program - Sault Area Hospital
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Scarborough, Ontario, Kanada, M1P 2T7
- The Scarborough Hospital
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Scarborough, Ontario, Kanada, M1E 5E9
- Rouge Valley Health System
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St. Catharines, Ontario, Kanada, L2R 7C6
- Niagara Health System
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Sudbury, Ontario, Kanada, P3E 5J1
- Northeast Cancer Centre of Health Sciences North - Horizon Sante-Nord
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Thunder Bay, Ontario, Kanada, P7B 6V4
- Thunder Bay Regional Health Sciences Centre
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Toronto, Ontario, Kanada, M5B 1W8
- St. Michael's Hospital
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Toronto, Ontario, Kanada, M4C 3E7
- Toronto East General Hospital
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Toronto, Ontario, Kanada, M5G 2M9
- Princess Margaret Hospital
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Toronto, Ontario, Kanada, M5G 1X5
- Mount Sinai Hospital
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Toronto, Ontario, Kanada, M2K 1E1
- North York General Hospital
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Toronto, Ontario, Kanada, M4N 3M5
- Sunnybrook Health Sciences - Odette Cancer Centre
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Toronto, Ontario, Kanada, M6R 1B5
- St. Joseph's Healthcare
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Toronto, Ontario, Kanada, M9C 1A5
- Trillium Health Centre
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Toronto, Ontario, Kanada, M9N 1N8
- Humber River Regional Cancer Centre
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Windsor, Ontario, Kanada, N8W 2X3
- Windsor Regional Cancer Centre
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Women or men with histologic evidence of invasive breast cancer (ductal, lobular or mixed disease).
- Surgical resection including breast conserving surgery or modified radical mastectomy or simple mastectomy, within the last four months.
Axillary lymph nodes assessed for tumor by:
(i) sentinel node biopsy, or (ii) axillary node dissection, or (iii) both
- Axillary lymph node assessment negative for cancer, or positive only for micrometastases (i.e., cancer <2mm by H&E stain).
- Tumor is estrogen receptor (ER) positive.
- Receiving or to receive adjuvant endocrine therapy (i.e., tamoxifen or aromatase inhibitor).
- Being considered for adjuvant chemotherapy.
Exclusion Criteria:
- Axillary lymph node positive for cancer.
- Patients with inoperable locally advanced breast cancer.
- Metastatic breast cancer, including local ipsilateral recurrence.
- HER2 neu positive.
- Physician/Patient unwilling to comply with study protocol.
- Inability to provide informed consent (e.g. dementia or severe cognitive impairment).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Early Stage Breast Cancer
Women and men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy.
|
Gene signature test containing 21 genes (16 cancer-related genes, e.g., invasion, proliferation, ER, Her 2 and five reference genes) and generates an individualized recurrence score.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in treatment recommendation
Tidsram: One month
|
The primary outcome is the change in treatment recommendation by the oncologist and the change in treatment preference of the patient.
|
One month
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Association between Oncotype DX® RS with other estimated risk calculations
Tidsram: One month
|
The level of association between the Oncotype DX® RS with estimated recurrence risk calculated by Adjuvant!
Online, as well as with traditional factors including tumor size, grade, and HER2 neu.
|
One month
|
|
Change in patient decisional conflict
Tidsram: One month
|
The change in the level of patient decisional conflict measured by the Decisional Conflict Scale (DCS).
Additionally, the DCS has three subscales: uncertainty, effective decision making, and factors contributing to uncertainty.
The change in each of these subscales will also be measured.
|
One month
|
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Robustness of economic model of sequential Adjuvant! Online followed by Oncotype DX®.
Tidsram: 6 months
|
To determine the robustness of the economic model of sequential Adjuvant!
Online followed by Oncotype DX®.
|
6 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Mark N. Levine, MD, Ontario Clinical Oncology Group (OCOG)
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2012
Primärt slutförande (Faktisk)
1 februari 2014
Avslutad studie (Faktisk)
1 februari 2014
Studieregistreringsdatum
Först inskickad
24 augusti 2011
Först inskickad som uppfyllde QC-kriterierna
24 augusti 2011
Första postat (Uppskatta)
26 augusti 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
27 mars 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 mars 2014
Senast verifierad
1 mars 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- OCOG-2011-ONCOTYPEDX
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .