Clinical trial NCT03688035: Potential of Circulating Tumor DNA to Assess the Tumor Response to Neoadjuvant Chemotherapy in Breast Cancer Patients
Official title: Prospective Study on the Potential of Circulating Tumor DNA to Assess the Tumor Response to Neoadjuvant Chemotherapy in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Neoadjuvant Chemotherapy
Circulating Tumor DNA
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patient receiving NAC in Shandong Cancer hospital

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: dynamic changes of plasma ctDNA mutant copies by a panel of 363 cancer-related genes
timeFrame: From patients recruited into the research until the surgury complete ,assessed up to 26 weeks.
Secondary outcomes:
measure: disease free survival after surgery
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Zhiyong Yu, PHD
role: STUDY_CHAIR
affiliation: Shandong Cancer Hospital and Institute
name: Zhaoyun Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: