Breast CancerIMPACtNCT02670577
Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry
An observational study of Breast Cancer, run by Agendia at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 481 participants
- Where
- 17 sitesUnited States
- Study dates
- Nov 2015to Aug 2017
- How long will I take part?
- 2 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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)
- OR
Show all 13Show fewer
- 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)
- OR
- 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)
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Akron General Medical Center
Akron, Ohio, 44302
Essex Oncology
Belleville, New Jersey, 07109
Roswell Park Cancer Institute
Buffalo, New York, 14263
Western Maryland Health System
Cumberland, Maryland, 21502
The Cancer Center at DeKalb Medical
Decatur, Georgia, 30033
St. Mary Medical Center
Langhorne, Pennsylvania, 19047
Sparrow Cancer Center
Lansing, Michigan, 48911
Methodist Hospital
Merrillville, Indiana, 46410
University of Miami
Miami, Florida, 33442
Aurora Cancer Care
Milwaukee, Wisconsin, 53226
Columbia St. Mary's
Milwaukee, Wisconsin
Community Healthcare System
Munster, Indiana, 46321
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Desert Regional Medical Center
Palm Springs, California, 92262
St. Clair Hospital
Pittsburgh, Pennsylvania, 15102
St. Joseph's Women's Hospital
Tampa, Florida, 33607
Cadence Cancer Center
Warrenville, Illinois, 60555
About this study
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.
Read the detailed description
Eligible patients will have their tumor sample analyzed for MammaPrint, BluePrint and TargetPrint. Patients cannot start treatment before the MammaPrint and BluePrint result is received and taken into consideration for the treatment plan. The clinical data are to be entered online. There will be 2 Case Report Forms (CRFs). Baseline clinical data and physician chemotherapy intention before knowing the MammaPrint and BluePrint result will be entered in CRF 1. After completion of CRF1, the MammaPrint and BluePrint result will be released. CRF2 will be completed after the final treatment decision has been made. This CRF will capture physician chemotherapy intention after the MammaPrint and BluePrint result and the impact of these results.
A sample size of 331 patients is required to detect a 25% overall treatment change (5% significance and 95% power) in stage I and II HR-positive, HER2-negative patients receiving adjuvant therapy.
In addition at least 50 T1a/bN0/1 (up to 1 node) Triple Negative, at least 50 T1a/bN0/1 (up to 1 node) HER2-positive breast cancer patients, and at least 50 patients receiving neoadjuvant therapy will be enrolled.
- Conditions
- Breast Cancer
- Keywords
- stage I, stage II, HER2 positive, Triple Negative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Treatment Decision
Compare treatment decision before and after test results.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startNov 2015
- Primary completion30 Apr 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 481 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Agendia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670577
- Sponsor's protocol ID
- IMPACt
- Acronym
- IMPACt
- Status last verified
- Jun 2018
- First submitted
- 27 Jan 2016
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32005181
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry
- ClinicalTrials.gov ID
- NCT02670577
- Acronym / sponsor ID
- IMPACt / IMPACt
- Conditions
- Breast Cancer
- Keywords
- stage I, stage II, HER2 positive, Triple Negative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 481 participants (estimated)
- Lead sponsor
- AgendiaIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 2 Feb 2016 (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.
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.
Detailed description
Eligible patients will have their tumor sample analyzed for MammaPrint, BluePrint and TargetPrint. Patients cannot start treatment before the MammaPrint and BluePrint result is received and taken into consideration for the treatment plan. The clinical data are to be entered online. There will be 2 Case Report Forms (CRFs). Baseline clinical data and physician chemotherapy intention before knowing the MammaPrint and BluePrint result will be entered in CRF 1. After completion of CRF1, the MammaPrint and BluePrint result will be released. CRF2 will be completed after the final treatment decision has been made. This CRF will capture physician chemotherapy intention after the MammaPrint and BluePrint result and the impact of these results.
A sample size of 331 patients is required to detect a 25% overall treatment change (5% significance and 95% power) in stage I and II HR-positive, HER2-negative patients receiving adjuvant therapy.
In addition at least 50 T1a/bN0/1 (up to 1 node) Triple Negative, at least 50 T1a/bN0/1 (up to 1 node) HER2-positive breast cancer patients, and at least 50 patients receiving neoadjuvant therapy will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Treatment Decision
Time frame: 6 weeks
Compare treatment decision before and after test results.
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 27 Jun 2018.
- Derived from this study: PubMed 32005181Soliman 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Agendia at 17 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 13 inclusion and 4 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
Change in Treatment Decision (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02670577, which also lists 1 linked publication.
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 27 Jun 2018.