TNBC - Triple-Negative Breast CancerB-STRONGER-INCT06230185
CtDNA Based MRD Testing for NAC Monitoring in TNBC
An observational study of TNBC - Triple-Negative Breast Cancer and Minimal Residual Disease, run by Personalis Inc. at 14 sites in United States.
Trial summary
A prospective, multicenter, observational study to evaluate the correlation of Molecular Residual Disease (MRD) detection using circulating tumor DNA guided test to pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer, Minimal Residual Disease
- How many people
- 422 participants
- Where
- 14 sitesUnited States
- Study dates
- 9 Nov 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Female patient who are scheduled to start NAC with early-stage Triple Negative Breast Cancer.
Who may be able to join
- Have histologically documented TNBC (defined as ER expression ≤10% by IHC, PR expression≤10% by IHC and HER2 0 or 1+ by IHC or FISH ratio <2 or HER2 gene copy number of <6).
- Early-stage breast cancer (stage I-III) and scheduled to undergo NAC treatment with curative intent.
- Be informed of the investigational nature of the study and all pertinent aspects of the trial.
- Have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines.
- Be ≥ 18years of age.
- Patient who are scheduled to start NAC.
- Be willing to provide blood samples before and during treatment.
- Have available biopsy tissue.
Who cannot join
- Receiving concurrent anti-neoplastic therapy for another malignancy.
- Stage IV disease.
- Current or history of another primary cancer within 5 years of study entry, with the exception of basal or squamous cell skin cancer, or non-invasive malignancy.
- History of allogeneic bone marrow or organ transplant.
- Blood transfusion within two weeks before collection of blood for central ctDNA testing.
- Started systemic therapy for their breast cancer.
- Pregnancy
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
University of Colorado Cancer Center
Aurora, Colorado, 80045
Sarah Kuptchik, 303-724-9844, sarah.kuptchik@cuanschutz.edu
Peter Kabos, MD
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Jill Schwartz Gomez, 713-792-2768, JSchwartz@mdanderson.org
Carlos Hernando Barcenas, MD
- Recruiting
Mount Sinai Medical Center of Florida
Miami Beach, Florida, 33140
Yvonne Enriquez-Nunez,, 305-674-2625, Yvonne.Enriquez@msmc.com
Oleg Gligich, MD
- Recruiting
Louisiana State University
New Orleans, Louisiana, 70112
Alexander Yates, 504-210-2828, ayate2@lsuhsc.edu
Michelle Loch, MD
- Recruiting
Nebraska Methodist
Omaha, Nebraska, 68114
Kathryn Bartz, 402-354-7939, Kathryn.bartz@nmhs.org
Kristen Leu, MD
- Recruiting
Illinois Cancer Care
Peoria, Illinois, 61615
Angie Earles, 309-243-3613, aearles@illinoiscancercare.com
Nadia Rehman, MD
- Recruiting
Oregon Oncology Specialists
Salem, Oregon, 97301
Jocelyn D Nostdahl, 503-561-4335, jnostdahl@orcancer.com
Janelle Meyer, MD
- Recruiting
Cancer Care Northwest
Spokane, Washington, 99202
Ronaye Wagner, 509-228-1680, research@ccnw.net
Kristen Rinn, MD
- Recruiting
Comprehensive Hematology Oncology (ONare Alliance, LLC / Exigent Research, LLC
St. Petersburg, Florida, 33709
Elizabeth Crenshaw, 727-344-6569 ext. 1025, ecrenshaw@comphemonc.com
Neeharika Makani, MD
- Recruiting
Stony Brook University Cancer Center
Stony Brook, New York, 11794
Pushpa Talanki, 631-638-0815, Pushpa.Talanki@stonybrookmedicine.edu
Alison Stopeck, MD
- Recruiting
Arizona Oncology
Tucson, Arizona, 85704
Stacey Kimbell, 520-668-5678, stacey.kimbell@usoncology.com
Rachel Swart, MD
- Recruiting
George Washington University
Washington D.C., District of Columbia, 20037
Richard Lush, 202-994-3647, rmlush3@email.gwu.edu
Pavani Chalasani, MD
- Recruiting
Cancer Care Associates of York
York, Pennsylvania, 17403
Clarissa Vega, 717-741-9229, cvega@cancercareyork.com
Joyce Huang, MD
- Recruiting
Trinity Health-Michigan
Ypsilanti, Michigan, 48197
Christina Munson, 734-712-3671, MCRCwebsitecontactform@trinity-health.org
Tareq Al Baghdadi, MD
About this study
Official title: Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)
A prospective, multicenter, observational study to evaluate the correlation of Molecular Residual Disease (MRD) detection using circulating tumor DNA guided test to pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). Results from this study aim to improve MRD detection and disease outcomes for future patients.
Read the detailed description
NeXT Personal CTA (Clinical Trial Assay) is a patient-specific, tumor-informed device which allows for detection of MRD from cfDNA. By using next generation sequencing technology, whole genome sequencing (WGS) is conducted from DNA derived from patient tumor and normal samples. A tumor informed personalized panel is then constructed that uses only a selection of DNA targets from the WGS by applying bioinformatic filters. The targeted personalized panel is then sequenced using NGS and DNA derived from cfDNA from plasma samples. The data from the cfDNA NGS are then further analyzed using bioinformatics filters to report the MRD status.
- Keywords
- ctDNA, Liquid Biopsy, Breast Cancer, MRD, NAC, TNBC, NeXT Personal®
- Medical subject headings
- Triple Negative Breast Neoplasms, Neoplasm, Residual, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the correlation of MRD to pCR after NAC in TNBC
Evaluate the correlation of MRD detection by NeXT Personal CTA to pathological Complete Response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). The pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.
Measured: through study completion, an average of 6 months
Secondary outcomes (1)
Evaluate the trajectory of changes in MRD to pCR or non pCR in TNBC
Evaluate the trajectory of changes in MRD detected by NeXT Personal CTA during neoadjuvant chemotherapy (NAC) to pathological Complete Response (pCR) or non pCR in stage I-III triple negative breast cancer (TNBC).
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start9 Nov 2023
- Primary completion30 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - Triple-Negative 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
- 422 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Personalis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Pavani Chalasani, George Washington University
- Investigators
- Pavani Chalasani, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230185
- Sponsor's protocol ID
- 01-PS-001
- Other IDs
- B-STRONGER-I
- Acronym
- B-STRONGER-I
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)
- ClinicalTrials.gov ID
- NCT06230185
- Acronym / sponsor ID
- B-STRONGER-I / 01-PS-001
- Keywords
- ctDNA, Liquid Biopsy, Breast Cancer, MRD, NAC, TNBC, NeXT Personal®
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 422 participants (estimated)
- Lead sponsor
- Personalis Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Jan 2024 (actual)
- 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.
A prospective, multicenter, observational study to evaluate the correlation of Molecular Residual Disease (MRD) detection using circulating tumor DNA guided test to pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). Results from this study aim to improve MRD detection and disease outcomes for future patients.
Detailed description
NeXT Personal CTA (Clinical Trial Assay) is a patient-specific, tumor-informed device which allows for detection of MRD from cfDNA. By using next generation sequencing technology, whole genome sequencing (WGS) is conducted from DNA derived from patient tumor and normal samples. A tumor informed personalized panel is then constructed that uses only a selection of DNA targets from the WGS by applying bioinformatic filters. The targeted personalized panel is then sequenced using NGS and DNA derived from cfDNA from plasma samples. The data from the cfDNA NGS are then further analyzed using bioinformatics filters to report the MRD status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patient who are scheduled to start NAC with early-stage Triple Negative Breast Cancer.
Key inclusion criteria (8 listed)
- Have histologically documented TNBC (defined as ER expression ≤10% by IHC, PR expression≤10% by IHC and HER2 0 or 1+ by IHC or FISH ratio <2 or HER2 gene copy number of <6).
- Early-stage breast cancer (stage I-III) and scheduled to undergo NAC treatment with curative intent.
- Be informed of the investigational nature of the study and all pertinent aspects of the trial.
- Have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines.
- Be ≥ 18years of age.
Key exclusion criteria (7 listed)
- Receiving concurrent anti-neoplastic therapy for another malignancy.
- Stage IV disease.
- Current or history of another primary cancer within 5 years of study entry, with the exception of basal or squamous cell skin cancer, or non-invasive malignancy.
- History of allogeneic bone marrow or organ transplant.
- Blood transfusion within two weeks before collection of blood for central ctDNA testing.
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
Evaluate the correlation of MRD to pCR after NAC in TNBC
Time frame: through study completion, an average of 6 months
Evaluate the correlation of MRD detection by NeXT Personal CTA to pathological Complete Response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). The pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.
1 secondary outcome
Evaluate the trajectory of changes in MRD to pCR or non pCR in TNBC
Time frame: through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Pavani Chalasani principal investigator
George Washington University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TNBC - Triple-Negative Breast Cancer and Minimal Residual Disease, run by Personalis Inc. at 14 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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soumya Chappidi (484-704-2599, schappidi@criteriuminc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the correlation of MRD to pCR after NAC in TNBC (time frame: through study completion, an average of 6 months). 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 7 Jan 2025.