NCT01617954

PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT01617954

Principal Investigator:

Study Type:

OBSERVATIONAL

Official Title:

PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score

Summary

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.

Eligibility

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

Disease(s) and\or Condition(s)

Hormone Receptor Positive Malignant Neoplasm of Breast

Primary Purpose

Intervention/Treatment

- Type: DEVICE
- Name: MammaPrint
- Description: All subjects
- Arm Group Labels: Subjects with MammaPrint Result

Sponsor

Agendia