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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Agendia
Sponsor:
Information provided by (Responsible Party):
Agendia
ClinicalTrials.gov Identifier:
NCT01617954
First received: June 8, 2012
Last updated: July 31, 2014
Last verified: July 2014
  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 ] [ 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617954

Contacts
Contact: Sarah Untch, MS sarah.untch@agendia.com
Contact: Lisette Stork, MSc lisette.stork@agendia.com

  Show 62 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: July 31, 2014
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 August 21, 2014