Breast CancerNBRSTNCT01479101
NBRST: Prospective Neo-adjuvant REGISTRY Trial
An observational study of Breast Cancer, run by Agendia at 76 sites in United States.
Trial summary
The scope of this registry study is to measure chemosensitivity as defined by pCR (primary endpoint), or endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category 1 (RCB1), a primary endpoint for neo-adjuvant endocrine therapy and a secondary endpoint… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MammaPrint 70-gene expression profile and BluePrint 80 gene expression profile
- How many people
- 1,142 participants
- Where
- 76 sitesUnited States
- Study dates
- Jul 2011to Jan 2021
- 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: Women with histologically proven breast cancer, who have started or are scheduled to start neo-adjuvant chemotherapy therapy or neo-adjuvant hormone therapy.
Who may be able to join
- Women with histologically proven breast cancer, who have started or are scheduled to start neo-adjuvant chemotherapy therapy or neo-adjuvant hormone therapy, after successful MammaPrint assay
- Age 18-90
- Written informed consent
Who cannot join
- Patients who have had excisional biopsy or axillary dissection Patients with confirmed distant metastatic disease
- Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC 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
76 sites in 1 country.
76 sites in 1 country
United States76 sites
Akron General Hospital
Akron, Ohio, 44302
Breast Care Specialists
Allentown, Pennsylvania, 18104
Texas Tech University
Amarillo, Texas
Austin Cancer Center
Austin, Texas, 78303
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, 94705
Advanced Breast Care Specialists
Bloomingdale, Illinois, 60108
McLaren Health Care
Burton, Michigan, 48509
The Breast Place
Charleston, South Carolina, 29406
Cancer Specialists of Charleston
Charleston, South Carolina, 29414
Virginia Breast Care
Charlottesville, Virginia, 22911
Ashikari Breast Center
Cortlandt Manor, New York, 10567
Dallas Surgical Group
Dallas, Texas, 75230
Texas Health
Dallas, Texas, 75230
Halifax Health Center for Oncology
Daytona Beach, Florida, 32114
Florida Hospital Memorial Medical Center
Daytona Beach, Florida, 32117
Dekalb Medical
Decatur, Georgia
Exempla Health St Joseph
Denver, Colorado, 80218
Hematology Oncology Associates of Central New York
East Syracuse, New York, 13057
McAllen Oncology
Edinburg, Texas
University Surgical Consultants
Elk Grove Village, Illinois, 60007
Evansville Surgical Associates
Evansville, Indiana, 47710
Theresa & Eugene M. Lang Research Center
Flushing, New York, 11355
21st Century Oncology
Fort Myers, Florida, 33907
Fresno Breast Surgery
Fresno, California, 93710
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Arizona Center for Cancer Care
Glendale, Arizona, 85306
Bellin Hospital
Green Bay, Wisconsin, 54313
Greenwich Hospital
Greenwich, Connecticut, 06830
Great Lakes Cancer Management Specialists
Grosse Pointe Woods, Michigan, 48236
Rockingham Memorial Hospital
Harrisonburg, Virginia, 22801
East Houston General Surgery
Houston, Texas, 77396
St. Vincent Healthcare
Jacksonville, Florida, 322004
St Lukes Cancer Center
Kansas City, Missouri, 64111
ACMH Cancer Center
Kittanning, Pennsylvania, 16201
The Breast Institute at JFK Medical Center
Lake Worth, Florida, 33461
St. Mary Medical Center
Langhorne, Pennsylvania, 19047
Signature Breast Care
Lanham, Maryland, 20706
Compehensive Cancer Care of Nevada
Las Vegas, Nevada, 89128
BreastLink
Long Beach, California, 90806
Long Beach Memorial Medical Center
Long Beach, California, 90806
Lynchburg Hematology Oncology Clinic
Lynchburg, Virginia, 24501
Baptist Health South Florida
Miami, Florida, 33183
Lakes Research
Miami Lakes, Florida, 33014
Bon Secours Virginia Breast Center
Midlothian, Virginia, 23114
Columbia St. Marys Cancer Center
Milwaukee, Wisconsin, 53211
Community Hospital of Monterey Peninsula
Monterey, California, 93940
Coastal Carolina Breast Center
Murrells Inlet, South Carolina, 29576
Nashville Breast Center
Nashville, Tennessee, 37203
Alta Bates
Oakland, California, 94609
University of Oklahoma
Oklahoma City, Oklahoma, 73104
University of Nebraska
Omaha, Nebraska, 68198
Comprehensive Cancer Center - Palm Springs
Palm Springs, California
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
St. Clair Hospital
Pittsburgh, Pennsylvania, 15243
Sutter Roseville Medical Center
Roseville, California, 95661
Kathryn A. Wagner Private Practice
San Antonio, Texas, 78205
Radiation Oncology of San Antonio
San Antonio, Texas
SHARP Memorial
San Diego, California
Redwood Regional
Santa Rosa, California
Center for Breast Care
Savannah, Georgia, 31404
21 Century Oncology
Scottsdale, Arizona, 85251
Swedish Cancer Institute
Seattle, Washington, 98104
Willis-Knighton Cancer Center
Shreveport, Louisiana, 71103
Hematology/Oncology of The North Shore
Skokie, Illinois, 60076
Northern Indiana Cancer Research
South Bend, Indiana, 46601
Providence Cancer Institute
Southfield, Michigan, 48075
Rockwood Clinic
Spokane, Washington, 99216
Christian Hospital
St Louis, Missouri, 63136
Stamford Hospital
Stamford, Connecticut, 06902
University of Toledo
Toledo, Ohio, 43614
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
Wheaton Franciscan Healthcare
Wauwatosa, Wisconsin, 53226
Wellness Oncology Hematology
West Hills, California, 91307
Wellness Oncology Hematology
West Hills, California
Virtua Health
Willingboro, New Jersey, 08046
About this study
Official title: Prospective Neo-adjuvant REGISTRY Trial Linking MammaPrint, Subtyping and Treatment Response: Neoadjuvant Breast Registry - Symphony Trial (NBRST) (Pronounced "in Breast")
The scope of this registry study is to measure chemosensitivity as defined by pCR (primary endpoint), or endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category 1 (RCB1), a primary endpoint for neo-adjuvant endocrine therapy and a secondary endpoint for neoadjuvant chemotherapy), metastasis-free survival and relapse-free survival(secondary endpoints) in molecular subgroups, determined by the established MammaPrint, BluePrint, Targetprint and Theraprint profiles in addition to possible novel expression profiles.
Read the detailed description
This will be a prospective observational, case-only study linking MammaPrint, BluePrint, TargetPrint, TheraPrint and possible additional profiles of interest to treatment response and Distant Metastases Free Survival (DMFS) and Relapse Free Survival (RFS). Only patients who receive neo-adjuvant therapy can participate.
For this project, approximately 50-70 institutions in the US will be invited to contribute clinical patient data from enrolled patients after a MammaPrint, TargetPrint, BluePrint and TheraPrint test has been successfully performed and the patient has started neo-adjuvant therapy.
Treatment is at the discretion of the physician, adhering to NCCN approved regimens or a recognized alternative.
The clinical data is to be entered online at 4 time points; amounting to four Case Report Forms (CRFs). Data will be collected on an ongoing basis, the first CRF must be completed within 6 weeks after the MammaPrint, BluePrint, TargetPrint, and TheraPrint result was provided. The second CRF should be completed 4 weeks after definitive surgery. CRF 3 and CRF4 will be completed 2-3 and 5 years after surgery.
It is expected that we will enroll around 1000 patients in 4 years.
OBJECTIVES
- Measure chemosensitivity (as defined by pCR) or endocrine sensitivity (as defined by decrease in longest tumor diameter or RCB1)in the molecular subgroups as determined by combining MammaPrint and BluePrint results.
- Correlate chemosensitivity (as defined by pCR) to TheraPrint Therapy Gene Assay results.
- Compare local IHC and FISH results (if available) with TargetPrint results. Compare the three BluePrint molecular subgroups with IHC-based subtype classification.
- Document impact of MammaPrint, TargetPrint and BluePrint result on treatment decision.
- Assess the 2-3 and 5 years DMFS and RFS for the different molecular subgroups.
- Measure chemosensitivity or endocrine sensitivity correlation with novel expression profiles.
- Conditions
- Breast Cancer
- Being tested
- MammaPrint 70-gene expression profile, BluePrint 80 gene expression profile
- Keywords
- neo adjuvant, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MammaPrint 70-gene expression profileOther
BluePrint 80 gene expression profileOther
| Study group | Role | What they receive |
|---|---|---|
| MammaPrint, BluePrint, neo-adj CT or HT | All patients receive the MammaPrint and BluePrint gene expression profile. Treatment at the discretion of the physician while adhering to NCCN guidelines. Receives: Other: MammaPrint 70-gene expression profile; Other: BluePrint 80 gene expression profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemosensitivity as defined by pCR
For neo-adjuvant chemotherapy patients the primary endpoint is pathological complete response (pCR) which is defined as the absence of invasive carcinoma in both the breast and axilla at microscopic examination of the resection specimen, regardless of the presence of carcinoma in situ. The response rate and corresponding confidence intervals will be presented as a proportion of all patients enrolled. Comparison of response rates between different molecular subgroups will be conducted using Pearson Chi-square test.
Measured: Up to 6 months
Endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category 1 (RCB1)
The primary endpoint for patients with neo-adjuvant hormonal therapy is partial response which is defined as decrease in longest tumor diameter. The response rate and corresponding confidence intervals will be presented as a proportion of all patients enrolled. Comparison of response rates between different molecular subgroups will be conducted using Pearson Chi-square test.
Measured: Up to 6 months
Secondary outcomes (5)
Correlate chemosensitivity (as defined by pCR) to TheraPrint Therapy Gene Assay results.
Correlation of chemosensitivity and endocrine sensitivity (as defined by pCR) to TheraPrint Therapy Gene Assay results will be determined using Pearson correlation and linear fit models.
Measured: Up to 6 months.
Assess metastasis-free survival and relapse-free survival in molecular subgroups, determined by the established MammaPrint, BluePrint, profiles.
Kaplan-Meier curves for DMFS will be calculated for the following eight subgroups
- Luminal subtype
- ERBB2 subtype
- Basal subtype
- Luminal subtype and high risk MammaPrint
- Luminal subtype and low risk MammaPrint
- ERBB2 subtype and high risk MammaPrint
- ERBB2 subtype and low risk MammaPrint
Measured: At -2-3 years and 5 years after definitive surgery.
Compare local IHC and FISH results (if available) with TargetPrint results.
Correlation of TargetPrint ER, PR, and HER2 microarray readout with IHC/FISH assessment will be determined using Pearson correlation and linear fit models. Agreement measurements between binary microarray and IHC classifications will be based on 2-way contingency table analysis and include overall concordance, positive agreement defined as the number of samples classified positive by both IHC and TargetPrint divided by the number of positive samples using IHC, negative agreement and Cohen's Kappa coefficient score.
Measured: Baseline; before start of neo-adjuvant therapy.
Compare the three BluePrint molecular subgroups with IHC-based subtype classification.
Correlation of BluePrint molecular subgroup microarray readout with IHC-based subtype classification.
Measured: Baseline; before start of neo-adjuvant therapy.
Document impact of MammaPrint, TargetPrint and BluePrint result on treatment decision.
Review the impact of MammaPrint, TargetPrint, and BluePrint on physician treatment decisions.
Measured: Baseline; before start neo-adjuvant therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2015
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agendia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pat Whitworth, MD, Principal investigator, Nashville Breast CenterStephanie Akbari, MD, Principal investigator, Reinsch Pierce Family Center for Breast HealthMark Gittleman, MD, Principal investigator, Breast Care SpecialistsPeter Beitsch, MD, Principal investigator, Dallas Surgical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479101
- Sponsor's protocol ID
- P0339 NBRST Registry
- Acronym
- NBRST
- Status last verified
- Jan 2021
- First submitted
- 18 Nov 2011
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Whitworth PW, Beitsch PD, Murray MK, Richards PD, Mislowsky A, Dul CL, Pellicane JV, Baron PL, Rahman RL, Lee LA, Dupree BB, Kelemen PR, Ashikari AY, Budway RJ, Lopez-Penalver C, Dooley W, Wang S, Dauer P, Menicucci AR, Yoder EB, Finn C, Blumencranz LE, Audeh W. Genomic Classification of HER2-Positive Patients With 80-Gene and 70-Gene Signatures Identifies Diversity in Clinical Outcomes With HER2-Targeted Neoadjuvant Therapy. JCO Precis Oncol. 2022 Sep;6:e2200197. doi: 10.1200/PO.22.00197.
PubMed 36108259Whitworth PW, Beitsch PD, Pellicane JV, Baron PL, Lee LA, Dul CL, Murray MK, Gittleman MA, Budway RJ, Rahman RL, Kelemen PR, Dooley WC, Rock DT, Cowan KH, Lesnikoski BA, Barone JL, Ashikari AY, Dupree BB, Wang S, Menicucci AR, Yoder EB, Finn C, Corcoran K, Blumencranz LE, Audeh W; NBRST Investigators Group. Distinct Neoadjuvant Chemotherapy Response and 5-Year Outcome in Patients With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Tumors That Reclassify as Basal-Type by the 80-Gene Signature. JCO Precis Oncol. 2022 Apr;6(1):e2100463. doi: 10.1200/PO.21.00463.
PubMed 35476550
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Neo-adjuvant REGISTRY Trial Linking MammaPrint, Subtyping and Treatment Response: Neoadjuvant Breast Registry - Symphony Trial (NBRST) (Pronounced "in Breast")
- ClinicalTrials.gov ID
- NCT01479101
- Acronym / sponsor ID
- NBRST / P0339 NBRST Registry
- Conditions
- Breast Cancer
- Keywords
- neo adjuvant, breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,142 participants (actual)
- Lead sponsor
- AgendiaIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 24 Nov 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.
The scope of this registry study is to measure chemosensitivity as defined by pCR (primary endpoint), or endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category 1 (RCB1), a primary endpoint for neo-adjuvant endocrine therapy and a secondary endpoint for neoadjuvant chemotherapy), metastasis-free survival and relapse-free survival(secondary endpoints) in molecular subgroups, determined by the established MammaPrint, BluePrint, Targetprint and Theraprint profiles in addition to possible novel expression profiles.
Detailed description
This will be a prospective observational, case-only study linking MammaPrint, BluePrint, TargetPrint, TheraPrint and possible additional profiles of interest to treatment response and Distant Metastases Free Survival (DMFS) and Relapse Free Survival (RFS). Only patients who receive neo-adjuvant therapy can participate.
For this project, approximately 50-70 institutions in the US will be invited to contribute clinical patient data from enrolled patients after a MammaPrint, TargetPrint, BluePrint and TheraPrint test has been successfully performed and the patient has started neo-adjuvant therapy.
Treatment is at the discretion of the physician, adhering to NCCN approved regimens or a recognized alternative.
The clinical data is to be entered online at 4 time points; amounting to four Case Report Forms (CRFs). Data will be collected on an ongoing basis, the first CRF must be completed within 6 weeks after the MammaPrint, BluePrint, TargetPrint, and TheraPrint result was provided. The second CRF should be completed 4 weeks after definitive surgery. CRF 3 and CRF4 will be completed 2-3 and 5 years after surgery.
It is expected that we will enroll around 1000 patients in 4 years.
OBJECTIVES
- Measure chemosensitivity (as defined by pCR) or endocrine sensitivity (as defined by decrease in longest tumor diameter or RCB1)in the molecular subgroups as determined by combining MammaPrint and BluePrint results.
- Correlate chemosensitivity (as defined by pCR) to TheraPrint Therapy Gene Assay results.
- Compare local IHC and FISH results (if available) with TargetPrint results. Compare the three BluePrint molecular subgroups with IHC-based subtype classification.
- Document impact of MammaPrint, TargetPrint and BluePrint result on treatment decision.
- Assess the 2-3 and 5 years DMFS and RFS for the different molecular subgroups.
- Measure chemosensitivity or endocrine sensitivity correlation with novel expression profiles.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MammaPrint, BluePrint, neo-adj CT or HT | – | Other: MammaPrint 70-gene expression profile, Other: BluePrint 80 gene expression profileAll patients receive the MammaPrint and BluePrint gene expression profile. Treatment at the discretion of the physician while adhering to NCCN guidelines. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with histologically proven breast cancer, who have started or are scheduled to start neo-adjuvant chemotherapy therapy or neo-adjuvant hormone therapy.
Key inclusion criteria (3 listed)
- Women with histologically proven breast cancer, who have started or are scheduled to start neo-adjuvant chemotherapy therapy or neo-adjuvant hormone therapy, after successful MammaPrint assay
- Age 18-90
- Written informed consent
Key exclusion criteria (4 listed)
- Patients who have had excisional biopsy or axillary dissection Patients with confirmed distant metastatic disease
- Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC 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 |
|---|---|---|
| MammaPrint 70-gene expression profile | Other | MammaPrint, BluePrint, neo-adj CT or HT |
| BluePrint 80 gene expression profile | Other | MammaPrint, BluePrint, neo-adj CT or HT |
Primary outcome
Chemosensitivity as defined by pCR
Time frame: Up to 6 months
For neo-adjuvant chemotherapy patients the primary endpoint is pathological complete response (pCR) which is defined as the absence of invasive carcinoma in both the breast and axilla at microscopic examination of the resection specimen, regardless of the presence of carcinoma in situ. The response rate and corresponding confidence intervals will be presented as a proportion of all patients enrolled. Comparison of response rates between different molecular subgroups will be conducted using Pearson Chi-square test.
Endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category 1 (RCB1)
Time frame: Up to 6 months
The primary endpoint for patients with neo-adjuvant hormonal therapy is partial response which is defined as decrease in longest tumor diameter. The response rate and corresponding confidence intervals will be presented as a proportion of all patients enrolled. Comparison of response rates between different molecular subgroups will be conducted using Pearson Chi-square test.
5 secondary outcomes
Correlate chemosensitivity (as defined by pCR) to TheraPrint Therapy Gene Assay results.
Time frame: Up to 6 months.
Assess metastasis-free survival and relapse-free survival in molecular subgroups, determined by the established MammaPrint, BluePrint, profiles.
Time frame: At -2-3 years and 5 years after definitive surgery.
Compare local IHC and FISH results (if available) with TargetPrint results.
Time frame: Baseline; before start of neo-adjuvant therapy.
Compare the three BluePrint molecular subgroups with IHC-based subtype classification.
Time frame: Baseline; before start of neo-adjuvant therapy.
Document impact of MammaPrint, TargetPrint and BluePrint result on treatment decision.
Time frame: Baseline; before start neo-adjuvant therapy.
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 19 Jan 2021.
- Derived from this study: PubMed 36108259Whitworth PW, Beitsch PD, Murray MK, Richards PD, Mislowsky A, Dul CL, Pellicane JV, Baron PL, Rahman RL, Lee LA, Dupree BB, Kelemen PR, Ashikari AY, Budway RJ, Lopez-Penalver C, Dooley W, Wang S, Dauer P, Menicucci AR, Yoder EB, Finn C, Blumencranz LE, Audeh W. Genomic Classification of HER2-Positive Patients With 80-Gene and 70-Gene Signatures Identifies Diversity in Clinical Outcomes With HER2-Targeted Neoadjuvant Therapy. JCO Precis Oncol. 2022 Sep;6:e2200197. doi: 10.1200/PO.22.00197.
- Derived from this study: PubMed 35476550Whitworth PW, Beitsch PD, Pellicane JV, Baron PL, Lee LA, Dul CL, Murray MK, Gittleman MA, Budway RJ, Rahman RL, Kelemen PR, Dooley WC, Rock DT, Cowan KH, Lesnikoski BA, Barone JL, Ashikari AY, Dupree BB, Wang S, Menicucci AR, Yoder EB, Finn C, Corcoran K, Blumencranz LE, Audeh W; NBRST Investigators Group. Distinct Neoadjuvant Chemotherapy Response and 5-Year Outcome in Patients With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Tumors That Reclassify as Basal-Type by the 80-Gene Signature. JCO Precis Oncol. 2022 Apr;6(1):e2100463. doi: 10.1200/PO.21.00463.
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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.
Pat Whitworth, MD principal investigator
Nashville Breast Center
Stephanie Akbari, MD principal investigator
Reinsch Pierce Family Center for Breast Health
Mark Gittleman, MD principal investigator
Breast Care Specialists
76 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 76 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 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 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 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?
Chemosensitivity as defined by pCR (time frame: Up to 6 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?
On the ClinicalTrials.gov record for NCT01479101, which also lists 2 linked publications.
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 19 Jan 2021.