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

This study is currently recruiting participants.
Verified April 2013 by Agendia
Sponsor:
Information provided by (Responsible Party):
Agendia
ClinicalTrials.gov Identifier:
NCT01617954
First received: June 8, 2012
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Hormone Receptor Positive Malignant Neoplasm of Breast
 Device: MammaPrint

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Agendia:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

Patients have the option to agree to the storage of excess samples at Agendia.


Estimated Enrollment: 820
Study Start Date: May 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects with MammaPrint Result Device: MammaPrint
All subjects
Other Name: 70 gene profile

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617954

  Show 55 Study Locations
Sponsors and Collaborators
Agendia
Investigators
Principal Investigator: Hatem Soliman, MD Moffitt Cancer Center
  More Information

No publications provided

Responsible Party: Agendia
ClinicalTrials.gov Identifier: NCT01617954     History of Changes
Other Study ID Numbers: PROMIS
Study First Received: June 8, 2012
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Recurrence
Neoplasms by Site
 Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013