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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01617954
First Posted: June 13, 2012
Last Update Posted: January 29, 2016
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.
Information provided by (Responsible Party):
Agendia
  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:


Further study details as provided by Agendia:

Primary Outcome Measures:
  • 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.

Enrollment: 820
Study Start Date: May 2012
Study Completion Date: December 2015
Primary Completion Date: December 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
Information from the National Library of Medicine

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


  Show 53 Study Locations
Sponsors and Collaborators
Agendia
Investigators
Principal Investigator: Michaela Tsai, MD Piper Breast Center
  More Information

Responsible Party: Agendia
ClinicalTrials.gov Identifier: NCT01617954     History of Changes
Other Study ID Numbers: PROMIS
First Submitted: June 8, 2012
First Posted: June 13, 2012
Last Update Posted: January 29, 2016
Last Verified: January 2016

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