Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients (SWITCH)

This study has been completed.
Sponsor:
Collaborator:
Registrat-Mapi
Information provided by (Responsible Party):
Genomic Health®, Inc.
ClinicalTrials.gov Identifier:
NCT01446185
First received: September 1, 2010
Last updated: April 17, 2013
Last verified: April 2013

September 1, 2010
April 17, 2013
January 2011
February 2012   (final data collection date for primary outcome measure)
impact of the Oncotype DX Recurrence Score on the treatment recommendation made [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
The impact of Oncotype DX on treatment recommendations can be either a decrease in treatment intensity defined as a change in treatment recommendation from chemotherapy plus hormonal therapy to hormonal therapy alone or an increase in treatment intensity defined as a movement from hormonal therapy alone to the addition of chemotherapy to hormonal therapy.
Same as current
Complete list of historical versions of study NCT01446185 on ClinicalTrials.gov Archive Site
  • Level of confidence of the physicians relating to their treatment recommendation before and after Oncotype DX RS results [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    The change in physicians' level of confidence in the treatment recommendation will be measured by the change from baseline to follow-up responses.
  • Physicians' perceptions regarding the utility of the Oncotype DX. [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients
Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients

Primary objective:

Determine the impact of the Oncotype DX Recurrence Score (RS) on the treatment recommendation made (administration of chemotherapy or not, in addition to hormonotherapy) in a HR+, N- or pN1(mi), Her2- breast cancer adjuvant population.

The impact of Oncotype DX on treatment recommendations can be either a decrease in treatment intensity defined as a change in treatment recommendation from chemotherapy plus hormonal therapy to hormonal therapy alone or an increase in treatment intensity defined as a movement from hormonal therapy alone to the addition of chemotherapy to hormonal therapy.

Patients with HR+, N- breast cancer currently represent around 70% of newly diagnosed breast cancers. These are usually good prognosis tumors. However, on the basis of classical clinical and pathological prognostic parameters and markers, the international consensus guidelines recommend treatment with hormone- and chemotherapy in 85-95% of the cases. Considering the natural disease history, such as documented by the EBCTCG meta-analysis, more than 50% of these patients are overtreated, which leads to unnecessary side effects and costs to the health system and to the society.

Oncotype DX appears to be well adapted to therapeutic de-escalation as it targets HR+, N- patients and is performed on fixed paraffin embedded tissue (FPET). It is therefore best adapted to daily clinical practice as it does not necessitate any specific surgical procedure or tissue freezing.

The prognostic and predictive value of Oncotype DX in ER+, N- patients has been validated on three large adjuvant randomized trials (NASBP B-14, NSABP B-20, and the ATAC study). The test has been commercially available in the USA since 2004, and is being used for more than 50% of the HR+ N- patients in this country.

While Oncotype DX has been validated in the USA, it needs to be independently evaluated in France, in the context of the local treatment guidelines and habits, to provide data that are meaningful to the French health system and to the French medical community.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Breast Cancer
Device: Oncotype DX breast cancer test
The Oncotype DX breast cancer test measures the expression of 21 genes of an individual tumor to generate an Recurrence Score result that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for early-stage breast cancer patients.
Other Name: Oncotype DX™
a HR+, N- or pN1(mi), Her2- breast cancer adjuvant population
Intervention: Device: Oncotype DX breast cancer test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients > 18 years old.
  2. Pre- or post- menopausal women with breast adenocarcinoma, confirmed by a pathologist and who underwent surgery, with a maximum of 4 weeks between surgery and the 2nd therapeutic decision with Oncotype DX.
  3. HR positive (at least ER+) breast cancer patients (defined by a threshold of 10% of the cells IHC + without N- or pN1(mi), Her2 - (IHC0, 1, 2+ or FISH -)
  4. Patients must be eligible to receive adjuvant chemotherapy as defined by a good Karnofsky index, no hematological, cardiological or hepatic contraindications nor any impeding comorbidity.
  5. Patients must have given a written informed consent.

Exclusion Criteria:

  1. T3 or T4, HR-, N+ (except pN1 (mi) (sn), Her2+ (IHC 3+ or Fish+) patients.
  2. Metastatic patients.
  3. Patients who cannot give an informed consent.
  4. Patients who cannot receive chemotherapy.
  5. Patient who participated in another clinical trial and is still in the exclusion period of any other trial.
  6. Mentally disabled patient who has no legal responsibility for herself.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01446185
2010-A00577-32, 2010-A00577-32
No
Genomic Health®, Inc.
Genomic Health®, Inc.
Registrat-Mapi
Principal Investigator: Joseph GLIGOROV Hôpital TENON
Genomic Health®, Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP