PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score (PROMIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agendia
ClinicalTrials.gov Identifier:
NCT01617954
First received: June 8, 2012
Last updated: January 28, 2016
Last verified: January 2016

June 8, 2012
January 28, 2016
May 2012
December 2015   (final data collection date for primary outcome measure)
Difference in recommended adjuvant chemotherapy treatment [ Time Frame: 30 days ] [ Designated as safety issue: No ]
The frequency of chemotherapy + endocrine versus endocrine alone decisions in Oncotype DX intermediate score patients will be calculated before and after receiving the MammaPrint result. A Chi-square test will be performed for the comparison of the two proportions.
Same as current
Complete list of historical versions of study NCT01617954 on ClinicalTrials.gov Archive Site
Not Provided
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PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score
PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score
This is a prospective study that will assess the impact of MammaPrint on chemotherapy + endocrine versus endocrine alone treatment decisions in patients with an Oncotype Intermediate Score.
The frequency of chemotherapy + endocrine versus endocrine alone decisions in Oncotype DX intermediate score patients will be calculated before and after receiving the MammaPrint result.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Patients have the option to agree to the storage of excess samples at Agendia.
Probability Sample
Patients with an Intermediate Recurrence Score
Hormone Receptor Positive Malignant Neoplasm of Breast
Device: MammaPrint
All subjects
Other Name: 70 gene profile
Subjects with MammaPrint Result
Intervention: Device: MammaPrint
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
820
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women with histologically proven invasive stage I-II, node negative, hormone receptor positive, Her2 negative breast cancer, who received an Oncotype DX intermediate score (18-30)
  • ≥ 18 years of age at time of consent
  • Written informed consent

Exclusion Criteria:

  • Insufficient tissue remaining for Mammaprint FFPE
  • Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
  • Women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy
Female
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01617954
PROMIS
No
Not Provided
Not Provided
Agendia
Agendia
Not Provided
Principal Investigator: Michaela Tsai, MD Piper Breast Center
Agendia
January 2016

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