PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score

Conditions

Hormone Receptor Positive Malignant Neoplasm of Breast

Brief 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.

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.

Patricia A. Robinson, Michaela L. Tsai, Shelly S. Lo, June Lee, Matei P. Socoteanu et al. (9 authors)

Journal of Clinical Oncology2021-05-203 citations

10.1200/jco.2021.39.15_suppl.e12568

Abstract P2-14-11: Treatment recommendations in ER+ patients ≤ 50 years: Comparison of the 21-gene assay and 70-gene signature in the PROMIS study

Michaela L. Tsai, Hatem Soliman, Shelly S. Lo, Rubina Qamar, Raye Budway et al. (14 authors)

Cancer Research2020-02-15

10.1158/1538-7445.sabcs19-p2-14-11

Abstract P4-08-10: MammaPrint identifies 46% of patients, age ≤50 years with oncotype RS 18-30, as low risk and safe to forgo chemotherapy

Hatem Soliman, Shelly S. Lo, R Qamar, Raye Budway, EG Levine et al. (14 authors)

Cancer Research2019-02-15

10.1158/1538-7445.sabcs18-p4-08-10

The 70-gene signature to provide risk stratification and treatment guidance for patients classified as intermediate by the 21-gene assay.

Michaela L. Tsai, Sarah Untch, Tina Treece, Shelly S. Lo, PROMIS Investigators Group

Journal of Clinical Oncology2016-05-204 citations

10.1200/jco.2016.34.15_suppl.571

Abstract OT3-3-01: PROMIS: PRospective study Of MammaPrint in breast cancer patients with an Intermediate recurrence Score (PROMIS)

Hatem Soliman, Sarah Untch, Lisette Stork

Cancer Research2015-05-01

10.1158/1538-7445.sabcs14-ot3-3-01

Abstract OT1-2-02: PROMIS: Prospective study of MammaPrint in breast cancer patients with an intermediate recurrence score (PROMIS)

H Soliman, Sarah Untch, Lisette Stork‐Sloots

Cancer Research2013-12-15

10.1158/0008-5472.sabcs13-ot1-2-02

Interventions

DEVICEMammaPrint

All subjects

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Difference in recommended adjuvant chemotherapy treatment	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.

Countries

United States

Outcome results

None listed