Hormone Receptor Positive Malignant Neoplasm of BreastPROMISNCT01617954
PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score
An observational study of Hormone Receptor Positive Malignant Neoplasm of Breast, run by Agendia at 53 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Hormone Receptor Positive Malignant Neoplasm of Breast
- What is being tested?
- MammaPrint
- Type of treatment
- Medical device
- How many people
- 820 participants
- Where
- 53 sitesUnited States
- Study dates
- May 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an Intermediate Recurrence Score
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
Hematology/Oncology Associates
Alexandria, Virginia
Northeast Georgia Cancer Care
Athens, Georgia, 30607
The Breast Institute at JFK Medical
Atlantis, Florida, 33462
MedStar Harbor Hospital
Baltimore, Maryland, 21225
Harry & Jeanette Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, 21237
Mercy Medical Center
Baltimore, Maryland
IU Health Bloomington
Bloomington, Indiana, 47402
St. Louis Cancer Care
Bridgeton, Missouri, 63044
Roswell Park Cancer Center
Buffalo, New York, 14203
Providence Saint Joseph Medical Center
Burbank, California, 91505
Lahey Clinic
Burlington, Massachusetts, 01805
Mount Auburn Hospital
Cambridge, Massachusetts, 02144
Charleston Cancer Center
Charleston, South Carolina, 29406
Loyola University Medical Center
Chicago, Illinois
Cookeville Regional Medical Center
Cookeville, Tennessee, 38501
Western Maryland Health System
Cumberland, Maryland, 21502
Texas Health
Dallas, Texas, 75230
Halifax Health Center for Oncology
Daytona Beach, Florida, 32114
Dekalb Medical Center
Decatur, Georgia, 30033
Exempla Saint Joseph Hospital
Denver, Colorado, 80218
Detroit Clinical Research Center
Detroit, Michigan
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
Regional Breast/21st Century Oncology
Fort Myers, Florida, 33907
MetroWest Medical Center
Framingham, Massachusetts, 01702
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Delnor Community Hospital
Geneva, Illinois, 60134
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Knoxville Comprehensive Breast Center
Knoxville, Tennessee, 37909
North Shore/Monter Cancer Center
Lake Success, New York, 11042
St. Mary Medical Center
Langhorne, Pennsylvania, 19047
Lynchburg Hematology Oncology Clinic
Lynchburg, Virginia, 24501
Columbia St. Mary's Cancer Center
Milwaukee, Wisconsin, 53211
Aurora Advanced Healthcare
Milwaukee, Wisconsin, 53226
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
Nashville Breast Center
Nashville, Tennessee, 37203
Columbia University
New York, New York
Orchard Healthcare Research
Northbrook, Illinois, 60062
University of Oklahoma
Oklahoma City, Oklahoma, 73117
Comprehensive Cancer Center
Palm Springs, California, 92262
Maricopa Integrated Health System
Phoenix, Arizona
St. Clair Hospital
Pittsburgh, Pennsylvania, 15243
Wheaton Franciscan Cancer Care - All Saints
Racine, Wisconsin, 53405
Breastlink
Santa Ana, California, 92705
Redwood Regional Cancer Center
Santa Rosa, California, 95403
Swedish Cancer Institute
Seattle, Washington, 98104
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
SSM Cancer Center
St Louis, Missouri, 63117
Stamford Hospital
Stamford, Connecticut, 06902
Tulsa Cancer Institute
Tulsa, Oklahoma, 74136
Covenant Medical Center
Waterloo, Iowa, 50702
CDH Cancer Center
Winfield, Illinois, 60190
St. Vincent Hospital
Worcester, Massachusetts, 01608
About this study
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.
Read the 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.
- Being tested
- MammaPrint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MammaPrintDevice
Also called 70 gene profile
All subjects
| Study group | Role | What they receive |
|---|---|---|
| Subjects with MammaPrint Result | Not described Receives: Device: MammaPrint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in recommended adjuvant chemotherapy treatment
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Receptor Positive Malignant Neoplasm of BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agendia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michaela Tsai, MD, Principal investigator, Piper Breast Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617954
- Sponsor's protocol ID
- PROMIS
- Acronym
- PROMIS
- Status last verified
- Jan 2016
- First submitted
- 8 Jun 2012
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score
- ClinicalTrials.gov ID
- NCT01617954
- Acronym / sponsor ID
- PROMIS / PROMIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 820 participants (actual)
- Lead sponsor
- AgendiaIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with MammaPrint Result | – | Device: MammaPrint |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an Intermediate Recurrence Score
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MammaPrintAlso: 70 gene profileAll subjects | Device | Subjects with MammaPrint Result |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michaela Tsai, MD principal investigator
Piper Breast Center
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hormone Receptor Positive Malignant Neoplasm of Breast, run by Agendia at 53 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in recommended adjuvant chemotherapy treatment (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2016.