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

Agendia

Status: Completed

Conditions: Hormone Receptor Positive Malignant Neoplasm of Breast

Treatments: Device: MammaPrint

Study type: Observational

Funder types: Industry

Identifiers

NCT01617954

PROMIS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 820 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

820 participants in 1 patient group

Subjects with MammaPrint Result

Treatment:

Device: MammaPrint