Stage III Breast CancerNCT04985357
Defining the Clinical Potential of Mass Response As a Biomarker for Patient Tumor Sensitivity to Drugs
An observational study of Stage III Breast Cancer and Stage IV Breast Cancer, run by Travera Inc.
Trial summary
The primary objective of this study, sponsored by Travera in Massachusetts, is to validate whether the mass response biomarker has potential to predict response of patients to specific therapies or therapeutic combinations using isolated tumor cells from varying cancers and biopsy formats. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Breast Cancer, Stage IV Breast Cancer, Stage III Lung Cancer
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to May 2030
- 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: General population with cohort matched diagnoses.
Who may be able to join
- Sample collection or biopsy of tumor is clinically indicated as part of SOC
- Prior to preceding onto therapy for treatment
Who cannot join
- Unable to obtain sufficient sample
About this study
The primary objective of this study, sponsored by Travera in Massachusetts, is to validate whether the mass response biomarker has potential to predict response of patients to specific therapies or therapeutic combinations using isolated tumor cells from varying cancers and biopsy formats.
- Conditions
- Stage III Breast Cancer, Stage IV Breast Cancer, Stage III Lung Cancer, Stage IV Lung Cancer, AML, Multiple Myeloma in Relapse
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Carcinoma, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Prostatic Neoplasms, Carcinoma, Hepatocellular, Carcinoma, Renal Cell
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 |
|---|---|---|
| Carcinoma-Associated Malignant Fluid | Diagnosis of any kind of carcinoma with a malignant fluid (pleural effusion or ascites) where drainage is clinically indicated as part of SOC, and a new course of treatment is upcoming. | |
| Carcinoma Solid Tissue Specimen | Diagnosis of any kind of carcinoma where a needle biopsy or tissue resection is clinically indicated as part of SOC, and a new course of treatment is upcoming. | |
| Multiple Myeloma | Diagnosis of relapsed multiple myeloma where bone marrow biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming. | |
| Acute myelogenous leukemia (AML) | Diagnosis of acute myelogenous leukemia where a blood draw or bone marrow biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming. | |
| Triple Negative Breast Cancer (TNBC) | Diagnosis of Stage IV Triple Negative Breast Cancer where a needle biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming. | |
| Peripheral Blood Cell Immune Competency | Diagnosis of any cancer where a blood draw is clinically indicated as part of SOC, a new course of treatment is upcoming, and checkpoint inhibitor therapy being considered for next line of treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best overall response (BOR)
The best overall response to therapy over 24 months will be captured for correlation with test outcomes.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study startNov 2024 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2030 (estimated)
Why it stopped: Abandoned prior to launch.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Travera Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Stevens, Ph.D., Principal investigator, Travera IncRobert Kimmerling, Ph.D., Principal investigator, Travera Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985357
- Sponsor's protocol ID
- TRV-002
- Status last verified
- Nov 2024
- First submitted
- 15 Jul 2021
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Clinical Potential of Mass Response As a Biomarker for Patient Tumor Sensitivity to Drugs
- ClinicalTrials.gov ID
- NCT04985357
- Acronym / sponsor ID
- TRV-002
- Conditions
- Stage III Breast Cancer, Stage IV Breast Cancer, Stage III Lung Cancer, Stage IV Lung Cancer, AML, Multiple Myeloma in Relapse
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Abandoned prior to launch.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Travera IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2024 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 2 Aug 2021 (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.
The primary objective of this study, sponsored by Travera in Massachusetts, is to validate whether the mass response biomarker has potential to predict response of patients to specific therapies or therapeutic combinations using isolated tumor cells from varying cancers and biopsy formats.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Carcinoma-Associated Malignant Fluid | – | –Diagnosis of any kind of carcinoma with a malignant fluid (pleural effusion or ascites) where drainage is clinically indicated as part of SOC, and a new course of treatment is upcoming. |
| Carcinoma Solid Tissue Specimen | – | –Diagnosis of any kind of carcinoma where a needle biopsy or tissue resection is clinically indicated as part of SOC, and a new course of treatment is upcoming. |
| Multiple Myeloma | – | –Diagnosis of relapsed multiple myeloma where bone marrow biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming. |
| Acute myelogenous leukemia (AML) | – | –Diagnosis of acute myelogenous leukemia where a blood draw or bone marrow biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming. |
| Triple Negative Breast Cancer (TNBC) | – | –Diagnosis of Stage IV Triple Negative Breast Cancer where a needle biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming. |
| Peripheral Blood Cell Immune Competency | – | –Diagnosis of any cancer where a blood draw is clinically indicated as part of SOC, a new course of treatment is upcoming, and checkpoint inhibitor therapy being considered for next line of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General population with cohort matched diagnoses.
Key inclusion criteria (2 listed)
- Sample collection or biopsy of tumor is clinically indicated as part of SOC
- Prior to preceding onto therapy for treatment
Key exclusion criteria (1 listed)
- Unable to obtain sufficient sample
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
Best overall response (BOR)
Time frame: up to 24 months
The best overall response to therapy over 24 months will be captured for correlation with test outcomes.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Stage III Breast Cancer
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 2/3
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
HER2-positive Breast Cancer
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
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.
Mark Stevens, Ph.D. principal investigator
Travera Inc
Robert Kimmerling, Ph.D. principal investigator
Travera Inc
Questions about this trial
What is this clinical trial studying?
An observational study of Stage III Breast Cancer and Stage IV Breast Cancer, run by Travera Inc.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Best overall response (BOR) (time frame: up to 24 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 25 Nov 2024.