Metastatic Breast CancerACTDNAGLTNCT05427617
Circulating Tumor DNA (ctDNA)-Guided Late-Line Treatment in Patients With Late-Stage Breast Cancer
An observational study of Metastatic Breast Cancer and Circulating Tumor DNA, run by Hunan Cancer Hospital.
Trial summary
This is a retrospective, observational, multi-center clinical study of circulating tumor DNA (ctDNA) to guide late-line therapy in late-stage metastatic breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic Breast Cancer, Circulating Tumor DNA, Gene Abnormality
- What is being tested?
- Case group
- How many people
- 223 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 30 Jun 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This cohort study recruited consecutive patients with recent progression of metastatic TNBC after multiple lines of chemotherapy or of HR+ or HER2+ metastatic breast cancer after multiple lines of endocrine or targeted therapy.
Who may be able to join
- Recent progression of TNBC after multiple lines of chemotherapy or of HR+ or HER2+ MBC after multiple lines of endocrine or targeted therapy;
- No available recommendation for the next treatment regimen;
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
- An updated, available pathological HR/HER2 status for metastasis;
- According to RECIST 1.1 standard, there should be at least one measurable target lesion;
- The expected survival time is > 3 months;
Show all 10Show fewer
- Those aged 18-70 years old;
- Liver and kidney function and blood routine test meet the following conditions: Neutrophil > 2.0g/l, Hb > 9g / L, PLT > 100g / L; ALT and AST < 2.5ULN; TBIL < 1.5ULN; Cr < 1.0ULN
- Signing informed consent;
- Those willing to accept polygenic testing.
Who cannot join
- Patients with multiple primary tumors;
- Those who are unable to obtain blood samples;
- Those with a history of immunodeficiency or organ transplantation;
- Those with abnormal cardiac function or previous history of myocardial infarction or serious arrhythmia;
- The researchers think it is not suitable to participate in this experiment.
About this study
Official title: Clinical Application of Circulating Tumor DNA (ctDNA) to Guided the Late-Line Treatment for Patients With Late-Stage Breast Cancer
This is a retrospective, observational, multi-center clinical study of circulating tumor DNA (ctDNA) to guide late-line therapy in late-stage metastatic breast cancer patients.
Read the detailed description
This study aims to evaluate the feasibility of plasma ctDNA mutation in guiding late-line treatment for late-stage metastatic breast cancer patients. Meanwhile, this study tries to evaluate the curative effect of ctDNA subtype-guided late-line therapy.
- Being tested
- Control group, Case group
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupDrug
Physician chosen treatment
Case groupDrug
Also called PARP inhibtior, EGFR inhibitor, CDK4/6 inhibitor, AR antagonists
Druggable ctDNA alterations-guided therapy
| Study group | Role | What they receive |
|---|---|---|
| Control group | Control group includes patients without ctDNA abnormality and patients without druggable ctDNA abnormality. Receives: Drug: Control group | |
| Case group | Case group includes patients with druggable ctDNA abnormality. Receives: Drug: Case group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (DCR)
The total rate of CR+PR+SD after the completion of two cycles of late-line therapy.
Measured: From the beginning of the treatment to the end of Cycle 2 (each cycle is 28 days) of treatment.
Progression-Free Survival
The survival time between the beginning of treatment to death or the progression.
Measured: From date of recruitment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Dec 2016
- Primary completion30 Jun 2019
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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-control
- Time perspective
- Retrospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427617
- Sponsor's protocol ID
- KYJJ-2020-022
- Acronym
- ACTDNAGLT
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Circulating Tumor DNA (ctDNA) to Guided the Late-Line Treatment for Patients With Late-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT05427617
- Acronym / sponsor ID
- ACTDNAGLT / KYJJ-2020-022
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 22 Jun 2022 (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.
This is a retrospective, observational, multi-center clinical study of circulating tumor DNA (ctDNA) to guide late-line therapy in late-stage metastatic breast cancer patients.
Detailed description
This study aims to evaluate the feasibility of plasma ctDNA mutation in guiding late-line treatment for late-stage metastatic breast cancer patients. Meanwhile, this study tries to evaluate the curative effect of ctDNA subtype-guided late-line therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Drug: Control groupControl group includes patients without ctDNA abnormality and patients without druggable ctDNA abnormality. |
| Case group | – | Drug: Case groupCase group includes patients with druggable ctDNA abnormality. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This cohort study recruited consecutive patients with recent progression of metastatic TNBC after multiple lines of chemotherapy or of HR+ or HER2+ metastatic breast cancer after multiple lines of endocrine or targeted therapy.
Key inclusion criteria (10 listed)
- Recent progression of TNBC after multiple lines of chemotherapy or of HR+ or HER2+ MBC after multiple lines of endocrine or targeted therapy;
- No available recommendation for the next treatment regimen;
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
- An updated, available pathological HR/HER2 status for metastasis;
- According to RECIST 1.1 standard, there should be at least one measurable target lesion;
Key exclusion criteria (5 listed)
- Patients with multiple primary tumors;
- Those who are unable to obtain blood samples;
- Those with a history of immunodeficiency or organ transplantation;
- Those with abnormal cardiac function or previous history of myocardial infarction or serious arrhythmia;
- The researchers think it is not suitable to participate in this experiment.
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 |
|---|---|---|
| Control groupPhysician chosen treatment | Drug | Control group |
| Case groupAlso: PARP inhibtior, EGFR inhibitor, CDK4/6 inhibitor, AR antagonistsDruggable ctDNA alterations-guided therapy | Drug | Case group |
Primary outcome
Disease Control Rate (DCR)
Time frame: From the beginning of the treatment to the end of Cycle 2 (each cycle is 28 days) of treatment.
The total rate of CR+PR+SD after the completion of two cycles of late-line therapy.
Progression-Free Survival
Time frame: From date of recruitment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
The survival time between the beginning of treatment to death or the progression.
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 22 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer and Circulating Tumor DNA, run by Hunan Cancer Hospital.
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 10 inclusion and 5 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 22 Jun 2022. 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 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?
Disease Control Rate (DCR) (time frame: From the beginning of the treatment to the end of Cycle 2 (each cycle is 28 days) of treatment.). 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 22 Jun 2022.