PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score

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.

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Key information

Conditions

Hormone Receptor Positive Malignant Neoplasm of Breast

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Maricopa Integrated Health System, Phoenix, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MammaPrint

Device

All subjects

Other names: 70 gene profile

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Agendia

Industry

Registry information

Acronym: PROMIS

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Jun 13, 2012
Registry last updated: Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed