Clinical Application of ctDNA Dynamic Monitoring in Neoadjuvant Therapy for HER2-positive Breast Cancer Patients

NCT06479460 | Recruiting

• 1 other identifier: ClINICALRESEARCH-001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To explore the predictive value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population;
2. 2.To evaluate the prognostic value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population.

Conditions

Breast Cancer; Neoadjuvant; HER2-positive Breast Cancer; Circulating Tumor DNA

Keywords

breast cancer; circulating tumor DNA; MRD

Outcome Measures

Primary Outcomes (1)

• Postoperative pathological pCR rate

  Postoperative pathological pCR rate of HER-2 positive breast cancer patients after completing neoadjuvant therapy and undergoing surgical resection

  2024.3 -- 2026. 3

Interventions

ctDNA-MRD DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• \) 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 30410101 BACKGROUND

• McDonald 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.

  PMID: 31391323 BACKGROUND

• Rothe 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.

  PMID: 30862692 BACKGROUND

• Cailleux 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.

  PMID: 36170624 BACKGROUND

• Magbanua 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.

  PMID: 33232761 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Collect peripheral blood samples from subjects at different treatment nodes, extract and test ctDNA nucleic acid samples for testing

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zhihone Zhang, Doctor of Medicine

CONTACT

18013348615; zhangzhih2001@aliyun.com

Jing Wu, Doctor of Medicine

CONTACT

18013348615

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: March 8, 2024
• Primary Completion: May 31, 2025
• Study Completion: March 31, 2026
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

CN (1)