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

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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

Study Description
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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.

Condition or disease Intervention/treatment
Hormone Receptor Positive Malignant Neoplasm of Breast Device: MammaPrint

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 Design
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Study Type : Observational
Actual Enrollment : 820 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score
Study Start Date : May 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Subjects with MammaPrint Result Device: MammaPrint
All subjects
Other Name: 70 gene profile


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Patients have the option to agree to the storage of excess samples at Agendia.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with an Intermediate Recurrence Score
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617954


Locations
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Sponsors and Collaborators
Agendia
Investigators
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Principal Investigator: Michaela Tsai, MD Piper Breast Center
More Information
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Responsible Party: Agendia
ClinicalTrials.gov Identifier: NCT01617954    
Other Study ID Numbers: PROMIS
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Neoplasms
Breast Neoplasms
Recurrence
Disease Attributes
 Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases