Breast CancerPhase 4MINTNCT01501487
MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I
A Phase 4 study testing TAC chemotherapy, TC chemotherapy and Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy in people with Breast Cancer, run by Agendia at 9 sites in United States.
Trial summary
Genomics assays that measure specific gene expression patterns in a patient's primary tumor have become important prognostic tools for breast cancer patients. This study is designed to test the ability of MammaPrint® in combination with TargetPrint®, BluePrint®, and TheraPrint®, as well as traditional pathologic and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TAC chemotherapy, TC chemotherapy and Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 9 sitesUnited States
- Study dates
- Oct 2011to Jun 2017
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with histologically proven invasive breast cancer and no distant metastases and;
- Lymphnode negative and a clinical tumor classification of T2 (≥3.5cm)-T4 or with 1-3 positive lymph nodes and a clinical tumor classification of T2-T4 DCIS or LCIS are allowed in addition to invasive cancer at T2 or T3 level.
- Age ≥ 18 years.
- At least one lesion that can be accurately measured in two dimensions utilizing mammogram, ultrasound, or MRI images to define specific size and validate complete pathologic response.
- Adequate bone marrow reserves (neutrophil count >1.5 x109 /l and platelet count >100 x109/l), adequate renal function (serum creatinine ≤ 1.5 x upper limit of normal) and hepatic function (ALAT, ASAT ≤ 2.5 x upper limit of normal, alkaline phosphatase ≤ 2.5 x upper limit of normal and total bilirubin ≤ 2.0 x upper limit of normal).
- Signed informed consent of the patient
Who cannot join
- Any patient with confirmed metastatic disease. Patients with inflammatory breast cancer.
- Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails Quality Assurance or Quality Control criteria.
- Patients who have had any prior chemotherapy, radiotherapy, or endocrine therapy for the treatment of breast cancer.
- Any serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Morton Plant Mease Health Care
Clearwater, Florida, 33756
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43212
University of Miami
Miami, Florida, 33124
University of South Alabama, Mitchell Cancer Institute
Mobile, Alabama, 36688
University of Oklahoma, Health Sciences Center
Oklahoma City, Oklahoma, 73104
Texas Health, Plano Cancer Institute
Plano, Texas, 75093
University of South Florida Breast Cancer Program
Tampa, Florida, 33613
Helen Ellis Memorial Hospital
Tarpon Springs, Florida, 34689
Eastchester Center for Cancer Care
The Bronx, New York, 10469
About this study
Genomics assays that measure specific gene expression patterns in a patient's primary tumor have become important prognostic tools for breast cancer patients. This study is designed to test the ability of MammaPrint® in combination with TargetPrint®, BluePrint®, and TheraPrint®, as well as traditional pathologic and clinical prognostic factors, to predict responsiveness to neo-adjuvant chemotherapy in patients with locally advanced breast cancer (LABC).
Read the detailed description
Patients with suspected primary breast cancer on mammography and clinical examination will be assessed for eligibility by having a needle core biopsy to confirm invasive carcinoma.
A fresh unfixed tumor specimen, incisional or core biopsy will be sent to Agendia to determine the MammaPrint risk profile, the BluePrint molecular subtyping profile, the TargetPrint ER, PR and HER2 single gene readout, the 56-geneTheraPrint Research Gene Panel and the additional genes as measured on the whole genome (44k) array.
Surgical Protocol:
- Determination of nodal status:
- For clinically node-negative patients: Axillary ultra sound, followed by Sentinel Lymph Node (SLN) biopsy
- For clinically node-positive patients: ultra sound-guided Fine Needle Aspirate (FNA), followed by core biopsy
- Neo-adjuvant chemotherapy
- Definitive surgery:
- For node-positive patients: lumpectomy, repeat SLN biopsy, Axillary Lymph Node Dissection (ALND)
- For node-negative patients: lumpectomy, repeat SLN biopsy (optional), no ALND
Response will be measured by pathological Complete Response (pCR) and by centrally assessed Residual Cancer Burden (RCB).
- Conditions
- Breast Cancer
- Being tested
- TAC chemotherapy, TC chemotherapy, Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy, TCH chemotherapy, T + trastuzumab followed by CEF + trastuzumab
- Keywords
- breast cancer, neo adjuvant therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAC chemotherapyDrug
Docetaxel 75 mg/m2 IV day 1, Doxorubicin 50 mg/m2 IV day 1, Cyclophosphamide 500 mg/m2 IV day 1; Cycled every 21 days for 6 cycles
TC chemotherapyDrug
Docetaxel 75 mg/m2 IV day 1, Cyclophosphamide 600 mg/m2 IV day 1; Cycled every 21 days for 6 cycles
Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapyDrug
Doxorubicin 60 mg/m2 IV day 1, Cyclophosphamide 600 mg/m2 IV day 1, Cycled every 14 days for 4 cycles, OR 5-Fluorouracil 500 mg/m2 IV day 1, Epirubicin 100 mg/m2 IV day 1, Cyclophosphamide 500 mg/m2 IV day 1; Cycled every 21 days for 3 cycles Followed by Paclitaxel 80 mg/m2 by 1 h IV infusion weekly for 12 weeks, OR Docetaxel 100mg/m2 IV day 1 cycled every 21 days for 3 or 4 cycles
TCH chemotherapyDrug
Docetaxel 75 mg/m2 IV day 1, followed by Carboplatin AUC 6 IV day 1; Cycled every 21 days for 6 cycles Trastuzumab initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over 30 minute IV infusion weekly for 52 weeks, OR initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30-90 minutes IV infusion every three weeks for 52 weeks.
T + trastuzumab followed by CEF + trastuzumabDrug
Trastuzumab 4 mg/kg IV for one dose beginning just prior to first dose of paclitaxel.
Followed by trastuzumab 2 mk/kg IV weekly for 23 weeks Paclitaxel 80 mg/m2 by 1 h IV infusion weekly for 12 wks Followed by 5-Fluorouracil 500 mg/m2 IV on days 1 and 4 Epirubicin 75 mg/m2 IV on day 1 Cyclophosphamide 500 mg/m2 IV on day 1 cycled every 21 days for 4 cycles Trastuzumab 6mg/kg IV every 21 days for 9 cycles to complete 1yr
Dose dense AC followed by T + trastuzumabDrug
Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 (cycled every 14 days for 4 cycles) Followed by paclitaxel 80 mg/m2 by 1 h IV infusion weekly for 12 wks All cycles are with filgrastim support with trastuzumab 2 mg/kg (4 mg/kg loading dose).
Following chemotherapy , trastuzumab to continue every 3 weeks at 6 mg/kg for the duration of 1 week.
Dose dense AC followed by T + trastuzumab + pertuzumabDrug
Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Cycled every 14 days for 4 cycles Followed by docetaxel 75-100 mg/m2 by 1 h IV infusion weekly for 12 wks All cycles are with filgrastim support with trastuzumab 6 mg/kg (8 mg/kg loading dose with C1) Pertuzumab 420 mg (840 mg loading dose with C1). Following chemotherapy, trastuzumab to continue every 3 weeks at 6 mg/kg for the duration of 1 week.
PTH followed by dose dense AC of FECDrug
Docetaxel 75-100 mg/m2 by 1 h IV infusion Cycled every 21 days for 4 cycles With Trastuzumab 6 mg/kg IV (8 mg/kg IV loading dose) q3W And Pertuzumab 420 mg IV (840 mg IV loading dose) q 3w +/- pegfilgrastim 6 mg sq on day 2-3,
Followed by 4 cycles of AC or FEC:
AC Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Cycled every 14 days for 4 cycles with pegfilgrastim 6 mg sq on day 2 FEC 5-Fluorouracil 500 mg/m2 IV on days 1 and 4 Epirubicin 75 mg/m2 IV on day 1 Cyclophosphamide 500 mg/m2 IV on day 1 cycled every 21 days for 4 cycles
In all of the above mentioned regimens docetaxel might be substituted with paclitaxel as paclitaxel is better tolerated but is expected to have the same efficacy as docetaxel.
| Study group | Role | What they receive |
|---|---|---|
| HER2 negative patients | Active comparator | In order to provide some consistency in management and have a treatment policy in place only recommended therapy with several well accepted and presumed equivalent chemotherapy regimens will be used. The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients include:
1. TAC chemotherapy
2. TC chemotherapy
3. Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy Receives: Drug: TAC chemotherapy; Drug: TC chemotherapy; Drug: Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy |
| Her2 positive patients | Active comparator | The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients is TCH chemotherapy. Receives: Drug: TCH chemotherapy; Drug: T + trastuzumab followed by CEF + trastuzumab; Drug: Dose dense AC followed by T + trastuzumab; Drug: Dose dense AC followed by T + trastuzumab + pertuzumab; Drug: PTH followed by dose dense AC of FEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the predictive power of chemosensitivity of MammaPrint as measured by pCR.
Measured: 6-12 months
Determine the predictive power of chemosensitivity of the combination of MammaPrint and BluePrint as measured by pCR.
Measured: 6-12 months
Secondary outcomes (4)
Compare TargetPrint single gene read out of ER, PR and HER2 with local and centralized IHC and/or CISH/FISH assessment of ER, PR and HER2.
Measured: Baseline. First study visit.
Identify possible correlations between the TheraPrint Research Gene Panel outcomes and chemoresponsiveness.
Measured: 6-9 months
Identify and/or validate predictive gene expression profiles of clinical response/resistance to chemotherapy.
Measured: 6-12 months
Compare the three BluePrint molecular subtype categories with IHC-based subtype classification.
Measured: Baseline. First study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agendia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of South Florida, University of Miami, Morton Plant Mease Health Care, AdventHealth, Plano Cancer Center, Ohio State University Comprehensive Cancer Center, University of Oklahoma, University of South Alabama
- Responsible party
- Sponsor
- Investigators
- Charles E Cox, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501487
- Sponsor's protocol ID
- P0334
- Acronym
- MINT
- Status last verified
- Jun 2018
- First submitted
- 22 Dec 2011
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I
- ClinicalTrials.gov ID
- NCT01501487
- Acronym / sponsor ID
- MINT / P0334
- Conditions
- Breast Cancer
- Keywords
- breast cancer, neo adjuvant therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- AgendiaIndustry (pharma, biotech, devices)
- Collaborators
- University of South Florida, University of Miami, Morton Plant Mease Health Care, AdventHealth, Plano Cancer Center, Ohio State University Comprehensive Cancer Center, University of Oklahoma, University of South Alabama
- Study start
- Oct 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 29 Dec 2011 (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.
Genomics assays that measure specific gene expression patterns in a patient's primary tumor have become important prognostic tools for breast cancer patients. This study is designed to test the ability of MammaPrint® in combination with TargetPrint®, BluePrint®, and TheraPrint®, as well as traditional pathologic and clinical prognostic factors, to predict responsiveness to neo-adjuvant chemotherapy in patients with locally advanced breast cancer (LABC).
Detailed description
Patients with suspected primary breast cancer on mammography and clinical examination will be assessed for eligibility by having a needle core biopsy to confirm invasive carcinoma.
A fresh unfixed tumor specimen, incisional or core biopsy will be sent to Agendia to determine the MammaPrint risk profile, the BluePrint molecular subtyping profile, the TargetPrint ER, PR and HER2 single gene readout, the 56-geneTheraPrint Research Gene Panel and the additional genes as measured on the whole genome (44k) array.
Surgical Protocol:
- Determination of nodal status:
- For clinically node-negative patients: Axillary ultra sound, followed by Sentinel Lymph Node (SLN) biopsy
- For clinically node-positive patients: ultra sound-guided Fine Needle Aspirate (FNA), followed by core biopsy
- Neo-adjuvant chemotherapy
- Definitive surgery:
- For node-positive patients: lumpectomy, repeat SLN biopsy, Axillary Lymph Node Dissection (ALND)
- For node-negative patients: lumpectomy, repeat SLN biopsy (optional), no ALND
Response will be measured by pathological Complete Response (pCR) and by centrally assessed Residual Cancer Burden (RCB).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HER2 negative patients | Active comparator | Drug: TAC chemotherapy, Drug: TC chemotherapy, Drug: Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapyIn order to provide some consistency in management and have a treatment policy in place only recommended therapy with several well accepted and presumed equivalent chemotherapy regimens will be used. The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients include: 1. TAC chemotherapy 2. TC chemotherapy 3. Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy |
| Her2 positive patients | Active comparator | Drug: TCH chemotherapy, Drug: T + trastuzumab followed by CEF + trastuzumab, Drug: Dose dense AC followed by T + trastuzumab, Drug: Dose dense AC followed by T + trastuzumab + pertuzumab, Drug: PTH followed by dose dense AC of FECThe proposed neo-adjuvant chemotherapy regimens for HER2 negative patients is TCH chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women with histologically proven invasive breast cancer and no distant metastases and;
- Lymphnode negative and a clinical tumor classification of T2 (≥3.5cm)-T4 or with 1-3 positive lymph nodes and a clinical tumor classification of T2-T4 DCIS or LCIS are allowed in addition to invasive cancer at T2 or T3 level.
- Age ≥ 18 years.
- At least one lesion that can be accurately measured in two dimensions utilizing mammogram, ultrasound, or MRI images to define specific size and validate complete pathologic response.
- Adequate bone marrow reserves (neutrophil count >1.5 x109 /l and platelet count >100 x109/l), adequate renal function (serum creatinine ≤ 1.5 x upper limit of normal) and hepatic function (ALAT, ASAT ≤ 2.5 x upper limit of normal, alkaline phosphatase ≤ 2.5 x upper limit of normal and total bilirubin ≤ 2.0 x upper limit of normal).
Key exclusion criteria (4 listed)
- Any patient with confirmed metastatic disease. Patients with inflammatory breast cancer.
- Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails Quality Assurance or Quality Control criteria.
- Patients who have had any prior chemotherapy, radiotherapy, or endocrine therapy for the treatment of breast cancer.
- Any serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease.
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 |
|---|---|---|
| TAC chemotherapyDocetaxel 75 mg/m2 IV day 1, Doxorubicin 50 mg/m2 IV day 1, Cyclophosphamide 500 mg/m2 IV day 1; Cycled every 21 days for 6 cycles | Drug | HER2 negative patients |
| TC chemotherapyDocetaxel 75 mg/m2 IV day 1, Cyclophosphamide 600 mg/m2 IV day 1; Cycled every 21 days for 6 cycles | Drug | HER2 negative patients |
| Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapyDoxorubicin 60 mg/m2 IV day 1, Cyclophosphamide 600 mg/m2 IV day 1, Cycled every 14 days for 4 cycles, OR 5-Fluorouracil 500 mg/m2 IV day 1, Epirubicin 100 mg/m2 IV day 1, Cyclophosphamide 500 mg/m2 IV day 1; Cycled every 21 days for 3 cycles Followed by Paclitaxel 80 mg/m2 by 1 h IV infusion weekly for 12 weeks, OR Docetaxel 100mg/m2 IV day 1 cycled every 21 days for 3 or 4 cycles | Drug | HER2 negative patients |
| TCH chemotherapyDocetaxel 75 mg/m2 IV day 1, followed by Carboplatin AUC 6 IV day 1; Cycled every 21 days for 6 cycles Trastuzumab initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over 30 minute IV infusion weekly for 52 weeks, OR initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30-90 minutes IV infusion every three weeks for 52 weeks. | Drug | Her2 positive patients |
| T + trastuzumab followed by CEF + trastuzumabTrastuzumab 4 mg/kg IV for one dose beginning just prior to first dose of paclitaxel. Followed by trastuzumab 2 mk/kg IV weekly for 23 weeks Paclitaxel 80 mg/m2 by 1 h IV infusion weekly for 12 wks Followed by 5-Fluorouracil 500 mg/m2 IV on days 1 and 4 Epirubicin 75 mg/m2 IV on day 1 Cyclophosphamide 500 mg/m2 IV on day 1 cycled every 21 days for 4 cycles Trastuzumab 6mg/kg IV every 21 days for 9 cycles to complete 1yr | Drug | Her2 positive patients |
| Dose dense AC followed by T + trastuzumabDoxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 (cycled every 14 days for 4 cycles) Followed by paclitaxel 80 mg/m2 by 1 h IV infusion weekly for 12 wks All cycles are with filgrastim support with trastuzumab 2 mg/kg (4 mg/kg loading dose). Following chemotherapy , trastuzumab to continue every 3 weeks at 6 mg/kg for the duration of 1 week. | Drug | Her2 positive patients |
| Dose dense AC followed by T + trastuzumab + pertuzumabDoxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Cycled every 14 days for 4 cycles Followed by docetaxel 75-100 mg/m2 by 1 h IV infusion weekly for 12 wks All cycles are with filgrastim support with trastuzumab 6 mg/kg (8 mg/kg loading dose with C1) Pertuzumab 420 mg (840 mg loading dose with C1). Following chemotherapy, trastuzumab to continue every 3 weeks at 6 mg/kg for the duration of 1 week. | Drug | Her2 positive patients |
| PTH followed by dose dense AC of FECDocetaxel 75-100 mg/m2 by 1 h IV infusion Cycled every 21 days for 4 cycles With Trastuzumab 6 mg/kg IV (8 mg/kg IV loading dose) q3W And Pertuzumab 420 mg IV (840 mg IV loading dose) q 3w +/- pegfilgrastim 6 mg sq on day 2-3, Followed by 4 cycles of AC or FEC: AC Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Cycled every 14 days for 4 cycles with pegfilgrastim 6 mg sq on day 2 FEC 5-Fluorouracil 500 mg/m2 IV on days 1 and 4 Epirubicin 75 mg/m2 IV on day 1 Cyclophosphamide 500 mg/m2 IV on day 1 cycled every 21 days for 4 cycles In all of the above mentioned regimens docetaxel might be substituted with paclitaxel as paclitaxel is better tolerated but is expected to have the same efficacy as docetaxel. | Drug | Her2 positive patients |
Primary outcome
Determine the predictive power of chemosensitivity of MammaPrint as measured by pCR.
Time frame: 6-12 months
Determine the predictive power of chemosensitivity of the combination of MammaPrint and BluePrint as measured by pCR.
Time frame: 6-12 months
4 secondary outcomes
Compare TargetPrint single gene read out of ER, PR and HER2 with local and centralized IHC and/or CISH/FISH assessment of ER, PR and HER2.
Time frame: Baseline. First study visit.
Identify possible correlations between the TheraPrint Research Gene Panel outcomes and chemoresponsiveness.
Time frame: 6-9 months
Identify and/or validate predictive gene expression profiles of clinical response/resistance to chemotherapy.
Time frame: 6-12 months
Compare the three BluePrint molecular subtype categories with IHC-based subtype classification.
Time frame: Baseline. First study visit.
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 28 Jun 2018.
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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.
Charles E Cox, MD principal investigator
University of South Florida
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TAC chemotherapy, TC chemotherapy and Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy in people with Breast Cancer, run by Agendia at 9 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 6 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 28 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 9 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Determine the predictive power of chemosensitivity of MammaPrint as measured by pCR. (time frame: 6-12 months). The study lists 2 primary outcomes in all. 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 28 Jun 2018.