Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry
IMPACt
1 other identifier
observational
481
1 country
17
Brief Summary
The scope of this study is to measure the impact of MammaPrint on treatment in Hormone Receptor (HR)-positive HER2-negative breast cancer patients. In addition, the impact of MammaPrint on treatment in patients with T1a/T1b and pN0/pN1 (up to 1 node), Triple Negative or HER2-positive tumors will be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 27, 2016
CompletedFirst Posted
Study publicly available on registry
February 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedJune 27, 2018
June 1, 2018
1.5 years
January 27, 2016
June 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Treatment Decision
Compare treatment decision before and after test results.
6 weeks
Study Arms (4)
stage I or II HR-positive, HER2-negative
Histologically proven invasive stage I and II breast cancer and Hormone Receptor positive \& HER2 negative \& Axillary lymph node status: 0-3 involved
HER2+
Histologically proven invasive T1a or T1b breast cancer \& Hormone receptor negative or positive \& HER2 positive \& Axillary lymph node status: 0-1 involved
Triple Negative
Histologically proven invasive T1a or T1b breast cancer \& Hormone receptor negative \& HER2 negative \& Axillary lymph node status: 0-1 involved
Neoadjuvant
Stage I or II patients receiving neoadjuvant therapy.
Eligibility Criteria
Stage I or II HR-positive, HER2-negative breast cancer patients AND T1a/b, N0/N1 (up to 1 node) Triple Negative, or HER2-positive breast cancer patients
You may qualify if:
- Eligible to receive chemotherapy and endocrine therapy as defined by a good Karnofsky index (≥80) and no hematologic, cardiologic or hepatic contraindications, nor any impeding comorbidity
- Informed consent form signed on the same day or before enrollment
- ≥ 18 years of age at time of consent Per study arm
- Histologically proven invasive stage I and II breast cancer and Hormone Receptor positive (ER+ PR-, ER- PR+ or ER+ PR+) according to local standards \& HER2 negative: IHC 0-1+, or FISH or other ISH non-amplified (locally assessed)
- IMPACt study; version 1 2015 September 1 Page 10 Axillary lymph node status: 0-3 involved (macro metastases i.e. \>2mm OR micro metastases i.e. \>0.2-2mm)
- Histologically proven invasive T1a or T1b breast cancer \& Hormone receptor negative (ER- and PR-) according to local standards \& HER2 negative: IHC 0-1+, or FISH or other ISH non-amplified (locally assessed)
- \& Axillary lymph node status: 0-1 involved (macro metastases i.e. \>2mm OR micro metastases i.e. \>0.2-2mm)
- Histologically proven invasive T1a or T1b breast cancer
- \& Hormone receptor negative or positive (ER-PR-, ER+PR-, ER-PR+, ER+PR+) according to local standards
- \& HER2 positive: IHC 3+, or FISH or other ISH amplified (locally assessed)
- \& Axillary lymph node status: 0-1 involved (macro metastases i.e. \>2mm OR micro metastases i.e. \>0.2-2mm)
You may not qualify if:
- Previous diagnosis of breast malignancy unless disease free for 10 years
- Metastatic disease
- 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 for current breast cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Agendialead
Study Sites (17)
Desert Regional Medical Center
Palm Springs, California, 92262, United States
University of Miami
Miami, Florida, 33442, United States
St. Joseph's Women's Hospital
Tampa, Florida, 33607, United States
The Cancer Center at DeKalb Medical
Decatur, Georgia, 30033, United States
Cadence Cancer Center
Warrenville, Illinois, 60555, United States
Methodist Hospital
Merrillville, Indiana, 46410, United States
Community Healthcare System
Munster, Indiana, 46321, United States
Western Maryland Health System
Cumberland, Maryland, 21502, United States
Sparrow Cancer Center
Lansing, Michigan, 48911, United States
Essex Oncology
Belleville, New Jersey, 07109, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Akron General Medical Center
Akron, Ohio, 44302, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
St. Mary Medical Center
Langhorne, Pennsylvania, 19047, United States
St. Clair Hospital
Pittsburgh, Pennsylvania, 15102, United States
Aurora Cancer Care
Milwaukee, Wisconsin, 53226, United States
Columbia St. Mary's
Milwaukee, Wisconsin, United States
Related Publications (1)
Soliman H, Shah V, Srkalovic G, Mahtani R, Levine E, Mavromatis B, Srinivasiah J, Kassar M, Gabordi R, Qamar R, Untch S, Kling HM, Treece T, Audeh W. MammaPrint guides treatment decisions in breast Cancer: results of the IMPACt trial. BMC Cancer. 2020 Jan 31;20(1):81. doi: 10.1186/s12885-020-6534-z.
PMID: 32005181DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2016
First Posted
February 2, 2016
Study Start
November 1, 2015
Primary Completion
April 30, 2017
Study Completion
August 1, 2017
Last Updated
June 27, 2018
Record last verified: 2018-06