Breast CancerNCT06479460
Clinical Application of ctDNA Dynamic Monitoring in Neoadjuvant Therapy for HER2-positive Breast Cancer Patients
An observational study of Breast Cancer and Neoadjuvant, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
1. To explore the predictive value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population; 2. To evaluate the prognostic value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Neoadjuvant, HER2-positive Breast Cancer
- What is being tested?
- ctDNA-MRD
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2024to 31 Mar 2026
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study plans to enroll 50 women patients with HER2 positive early (T2-3, N0-1, M0)/local late (T2-3, N2-3, M0 or T4a-c, Nany, M0) breast cancer, who can accept new adjuvant treatment, voluntarily sign the informed consent form, timely and sufficiently obtain tumor tissue and peripheral blood samples for testing, and are willing to cooperate with follow-up.
Who may be able to join
- Women with breast cancer diagnosed clinically and pathologically, aged 18-75 years;
- ECOG performance score is 0-1;
- Histologically confirmed as early or locally advanced invasive breast cancer: the diameter of the primary tumor is more than 2 cm, and HER2 is positive (confirmed by IHC or FISH).
- The patient did not receive any treatment for breast cancer before enrollment;
- Having lesions measurable according to RECIST 1.1 standards;
- The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up; 7) Breast cancer patients who plan to use neoadjuvant therapy.
Who cannot join
- Patients with known metastatic or stage IV breast cancer;
- There are other untreated malignant tumors other than breast cancer;
- Patients with one or more serious systemic diseases that, in the eyes of researchers, can impair their ability to complete research;
- According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study midway, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors, which may affect the safety of the subjects or the collection of experimental data.
- Unable to follow up with the study according to the determined clinical follow-up period;
- Cannot accept or provide specified efficacy evaluation methods such as CT.
Show all 9Show fewer
- Unable to obtain sufficient tumor tissue samples or peripheral blood samples.
- 1) Patients with known metastatic or stage IV breast cancer; 2) There are other incurable malignant tumors present; 3) One or more serious systemic diseases that, in the eyes of researchers, can impair the patient's ability to complete the study; 4) According to the researcher's judgment, there are other factors that may cause the subject to be forced to terminate the study midway, such as other serious illnesses (including mental illness) requiring concurrent treatment, severe abnormal laboratory test values, family or social factors, which may affect the safety of the subject or the collection of trial data.
- 5) Unable to follow the determined clinical follow-up period in conjunction with the study for follow-up; 6) Unable to accept or provide specified efficacy evaluation methods such as CT.
Trial locations and contacts
1 site in 1 country.
Jing Wu, Doctor of Medicine contact
China1 site, 1 recruiting
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Zhihong Zhang, Doctor of Medicine, 13032542620, zhangzhih2001@aliyun.com
Jing Wu, Doctor of Medicine, 18013348615, wuj_425@163.com
About this study
Official title: Director, Department of Pathology, Jiangsu Provincial People's Hospital
- To explore the predictive value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population;
- To evaluate the prognostic value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population.
Read the detailed description
This study plans to enroll 50 HER2 positive breast cancer patients in early stage (T2-3, N0-1, M0)/local late stage (T2-3, N2-3, M0 or T4a-c, Nany, M0), collect baseline tumor tissue samples of patients, as well as peripheral blood samples of multiple nodes at baseline, during new adjuvant therapy, after new adjuvant therapy (before surgery), and after surgery, detect the mutation of tumor tissue through 1021 panel, and conduct ctDNA detection of peripheral blood samples based on personalized panel design based on tumor tissue specific mutations, to explore the efficacy prediction and prognostic predictive value of ctDNA in HER2 positive new adjuvant therapy population.
- Being tested
- ctDNA-MRD
- Keywords
- breast cancer, circulating tumor DNA, MRD
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNA-MRDDiagnostic test
This study is an observational non intervention study that only tests peripheral blood samples from different treatment nodes of the subjects, without interfering with the normal clinical diagnosis and treatment process of the patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pathological pCR rate
Postoperative pathological pCR rate of HER-2 positive breast cancer patients after completing neoadjuvant therapy and undergoing surgical resection
Measured: 2024.3 -- 2026. 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start8 Mar 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479460
- Sponsor's protocol ID
- ClINICALRESEARCH-001
- Status last verified
- Jul 2024
- First submitted
- 24 Jun 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heitzer E, Haque IS, Roberts CES, Speicher MR. Current and future perspectives of liquid biopsies in genomics-driven oncology. Nat Rev Genet. 2019 Feb;20(2):71-88. doi: 10.1038/s41576-018-0071-5.
PubMed 30410101McDonald BR, Contente-Cuomo T, Sammut SJ, Odenheimer-Bergman A, Ernst B, Perdigones N, Chin SF, Farooq M, Mejia R, Cronin PA, Anderson KS, Kosiorek HE, Northfelt DW, McCullough AE, Patel BK, Weitzel JN, Slavin TP, Caldas C, Pockaj BA, Murtaza M. Personalized circulating tumor DNA analysis to detect residual disease after neoadjuvant therapy in breast cancer. Sci Transl Med. 2019 Aug 7;11(504):eaax7392. doi: 10.1126/scitranslmed.aax7392.
PubMed 31391323Rothe F, Silva MJ, Venet D, Campbell C, Bradburry I, Rouas G, de Azambuja E, Maetens M, Fumagalli D, Rodrik-Outmezguine V, Di Cosimo S, Rosa D, Chia S, Wardley A, Ueno T, Janni W, Huober J, Baselga J, Piccart M, Loi S, Sotiriou C, Dawson SJ, Ignatiadis M. Circulating Tumor DNA in HER2-Amplified Breast Cancer: A Translational Research Substudy of the NeoALTTO Phase III Trial. Clin Cancer Res. 2019 Jun 15;25(12):3581-3588. doi: 10.1158/1078-0432.CCR-18-2521. Epub 2019 Mar 12.
PubMed 30862692Cailleux F, Agostinetto E, Lambertini M, Rothe F, Wu HT, Balcioglu M, Kalashnikova E, Vincent D, Viglietti G, Gombos A, Papagiannis A, Veys I, Awada A, Sethi H, Aleshin A, Larsimont D, Sotiriou C, Venet D, Ignatiadis M. Circulating Tumor DNA After Neoadjuvant Chemotherapy in Breast Cancer Is Associated With Disease Relapse. JCO Precis Oncol. 2022 Sep;6:e2200148. doi: 10.1200/PO.22.00148.
PubMed 36170624Magbanua MJM, Swigart LB, Wu HT, Hirst GL, Yau C, Wolf DM, Tin A, Salari R, Shchegrova S, Pawar H, Delson AL, DeMichele A, Liu MC, Chien AJ, Tripathy D, Asare S, Lin CJ, Billings P, Aleshin A, Sethi H, Louie M, Zimmermann B, Esserman LJ, van 't Veer LJ. Circulating tumor DNA in neoadjuvant-treated breast cancer reflects response and survival. Ann Oncol. 2021 Feb;32(2):229-239. doi: 10.1016/j.annonc.2020.11.007. Epub 2020 Nov 21.
PubMed 33232761
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Director, Department of Pathology, Jiangsu Provincial People's Hospital
- ClinicalTrials.gov ID
- NCT06479460
- Acronym / sponsor ID
- ClINICALRESEARCH-001
- Keywords
- breast cancer, circulating tumor DNA, MRD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 28 Jun 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.
- To explore the predictive value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population;
- To evaluate the prognostic value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population.
Detailed description
This study plans to enroll 50 HER2 positive breast cancer patients in early stage (T2-3, N0-1, M0)/local late stage (T2-3, N2-3, M0 or T4a-c, Nany, M0), collect baseline tumor tissue samples of patients, as well as peripheral blood samples of multiple nodes at baseline, during new adjuvant therapy, after new adjuvant therapy (before surgery), and after surgery, detect the mutation of tumor tissue through 1021 panel, and conduct ctDNA detection of peripheral blood samples based on personalized panel design based on tumor tissue specific mutations, to explore the efficacy prediction and prognostic predictive value of ctDNA in HER2 positive new adjuvant therapy population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study plans to enroll 50 women patients with HER2 positive early (T2-3, N0-1, M0)/local late (T2-3, N2-3, M0 or T4a-c, Nany, M0) breast cancer, who can accept new adjuvant treatment, voluntarily sign the informed consent form, timely and sufficiently obtain tumor tissue and peripheral blood samples for testing, and are willing to cooperate with follow-up.
Key inclusion criteria (6 listed)
- Women with breast cancer diagnosed clinically and pathologically, aged 18-75 years;
- ECOG performance score is 0-1;
- Histologically confirmed as early or locally advanced invasive breast cancer: the diameter of the primary tumor is more than 2 cm, and HER2 is positive (confirmed by IHC or FISH).
- The patient did not receive any treatment for breast cancer before enrollment;
- Having lesions measurable according to RECIST 1.1 standards;
Key exclusion criteria (9 listed)
- Patients with known metastatic or stage IV breast cancer;
- There are other untreated malignant tumors other than breast cancer;
- Patients with one or more serious systemic diseases that, in the eyes of researchers, can impair their ability to complete research;
- According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study midway, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors, which may affect the safety of the subjects or the collection of experimental data.
- Unable to follow up with the study according to the determined clinical follow-up period;
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 |
|---|---|---|
| ctDNA-MRDThis study is an observational non intervention study that only tests peripheral blood samples from different treatment nodes of the subjects, without interfering with the normal clinical diagnosis and treatment process of the patients. | Diagnostic test | – |
Primary outcome
Postoperative pathological pCR rate
Time frame: 2024.3 -- 2026. 3
Postoperative pathological pCR rate of HER-2 positive breast cancer patients after completing neoadjuvant therapy and undergoing surgical resection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Background: PubMed 30410101Heitzer E, Haque IS, Roberts CES, Speicher MR. Current and future perspectives of liquid biopsies in genomics-driven oncology. Nat Rev Genet. 2019 Feb;20(2):71-88. doi: 10.1038/s41576-018-0071-5.
- Background: PubMed 31391323McDonald BR, Contente-Cuomo T, Sammut SJ, Odenheimer-Bergman A, Ernst B, Perdigones N, Chin SF, Farooq M, Mejia R, Cronin PA, Anderson KS, Kosiorek HE, Northfelt DW, McCullough AE, Patel BK, Weitzel JN, Slavin TP, Caldas C, Pockaj BA, Murtaza M. Personalized circulating tumor DNA analysis to detect residual disease after neoadjuvant therapy in breast cancer. Sci Transl Med. 2019 Aug 7;11(504):eaax7392. doi: 10.1126/scitranslmed.aax7392.
- Background: PubMed 30862692Rothe F, Silva MJ, Venet D, Campbell C, Bradburry I, Rouas G, de Azambuja E, Maetens M, Fumagalli D, Rodrik-Outmezguine V, Di Cosimo S, Rosa D, Chia S, Wardley A, Ueno T, Janni W, Huober J, Baselga J, Piccart M, Loi S, Sotiriou C, Dawson SJ, Ignatiadis M. Circulating Tumor DNA in HER2-Amplified Breast Cancer: A Translational Research Substudy of the NeoALTTO Phase III Trial. Clin Cancer Res. 2019 Jun 15;25(12):3581-3588. doi: 10.1158/1078-0432.CCR-18-2521. Epub 2019 Mar 12.
- Background: PubMed 36170624Cailleux F, Agostinetto E, Lambertini M, Rothe F, Wu HT, Balcioglu M, Kalashnikova E, Vincent D, Viglietti G, Gombos A, Papagiannis A, Veys I, Awada A, Sethi H, Aleshin A, Larsimont D, Sotiriou C, Venet D, Ignatiadis M. Circulating Tumor DNA After Neoadjuvant Chemotherapy in Breast Cancer Is Associated With Disease Relapse. JCO Precis Oncol. 2022 Sep;6:e2200148. doi: 10.1200/PO.22.00148.
- Background: PubMed 33232761Magbanua MJM, Swigart LB, Wu HT, Hirst GL, Yau C, Wolf DM, Tin A, Salari R, Shchegrova S, Pawar H, Delson AL, DeMichele A, Liu MC, Chien AJ, Tripathy D, Asare S, Lin CJ, Billings P, Aleshin A, Sethi H, Louie M, Zimmermann B, Esserman LJ, van 't Veer LJ. Circulating tumor DNA in neoadjuvant-treated breast cancer reflects response and survival. Ann Oncol. 2021 Feb;32(2):229-239. doi: 10.1016/j.annonc.2020.11.007. Epub 2020 Nov 21.
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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.
Jing Wu, Doctor of Medicine contact
1 site 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 and Neoadjuvant, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 9 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: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhihone Zhang, Doctor of Medicine (18013348615, zhangzhih2001@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pathological pCR rate (time frame: 2024.3 -- 2026. 3). 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 NCT06479460, which also lists 5 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 24 Jul 2024.