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

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: NCT01617954
Recruitment Status : Completed
First Posted : June 13, 2012
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
Agendia

Tracking Information
First Submitted Date June 8, 2012
First Posted Date June 13, 2012
Last Update Posted Date January 29, 2016
Study Start Date May 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2012)		 Difference in recommended adjuvant chemotherapy treatment [ Time Frame: 30 days ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score
Official Title PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Patients have the option to agree to the storage of excess samples at Agendia.
Sampling Method Probability Sample
Study Population Patients with an Intermediate Recurrence Score
Condition Hormone Receptor Positive Malignant Neoplasm of Breast
Intervention Device: MammaPrint
All subjects
Other Name: 70 gene profile
Study Groups/Cohorts Subjects with MammaPrint Result
Intervention: Device: MammaPrint
Publications * Not Provided

*   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: April 18, 2013)		 820
Original Estimated Enrollment
 (submitted: June 11, 2012)		 300
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01617954
Other Study ID Numbers PROMIS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Agendia
Original Responsible Party Same as current
Current Study Sponsor Agendia
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Michaela Tsai, MD Piper Breast Center
PRS Account Agendia
Verification Date January 2016