Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03688035
Other study ID # ShandongCHI-08
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 20, 2018
Est. completion date September 20, 2019

Study information

Verified date September 2018
Source Shandong Cancer Hospital and Institute
Contact Zhiyong Yu, PhD
Phone 86-13355312277
Email drzhiyongyu@aliyun.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Breast cancer is the most common malignant tumor in women worldwide,and there exist a large part of patients need to receive neoadjuvant chemotherapy(NAC) before the curative surgery.Circulating tumor DNA(ctDNA) is the circulating free DNA in the blood that originates from cancers,and it can be detected by modern technologies in plasma.In this prospective study,investigators aim to observe the correlation between tumor response to neoadjuvant chemotherapy and ctDNA.


Description:

Women with node-positive breast cancer are at high risk for recurrence. Neoadjuvant chemotherapy is traditionally for locally advanced disease, converting an inoperable tumor to a resectable one.In the present study, investigators will focus on breast cancer patients whose primary tumors are large or have lymph node metastases and need to receive neoadjuvant chemotherapy from 2018 to 2019. Circulating tumor DNA(ctDNA) will be obtained from peripheral blood,and the blood samples will be taken before the neoadjuvant chemotherapy、during the chemotherapy、 before the surgery and post surgery visit (within 24 hours after surgery) .Investigators will collect tissue samples both from the breast lump biopsy and the curative surgery. Investigators aim to investigate whether circulating tumor DNA is a sensitive marker to monitor the efficacy of neoadjuvant chemotherapy in breast cancer.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date September 20, 2019
Est. primary completion date September 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Female patients undergoing neoadjuvant chemotherapy

- Age: 18-70 yrs

- Any menopausal status

- Any hormone receptor status

- Invasive breast cancer proven histologically at diagnosis (before neoadjuvant chemotherapy):

- Locally advanced tumor

- Patients who received 6 to 8 cycles of neoadjuvant chemotherapy.

Exclusion Criteria:

- Failed to retain blood sample before NAC

- Lost more than 2 blood samples during NAC

Study Design


Locations

Country Name City State
China Shandong Cancer Hospital and Institute Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Zhiyong Yu

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary dynamic changes of plasma ctDNA mutant copies by a panel of 363 cancer-related genes To assess the changes of ctDNA mutant copies during the process of our observation,and to find out the relationship between ctDNA and tumor response to neoadjuvant chemotherapy From patients recruited into the research until the surgury complete ,assessed up to 26 weeks.
Secondary disease free survival after surgery To observe the duration from the end of curative surgery to local recurrence or distant metastasis of breast cancer. Patients were followed up every six months in first three years, then followed up once a year. Up to 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Recruiting NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2