Clinical trial NCT03881384: Circulating Tumor DNA as Marker of Therapeutic Efficacy in Breast Cancer Patients
Official title: Early Evaluation of Circulating Tumor DNA as Marker of Therapeutic Efficacy in Breast Cancer Patients During Neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
Keywords: ctDNA
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that are considered possible candidates for neoadjuvant chemotherapy, by clinical-pathologic features.

Brief summary: In nonmetastatic local advanced breast cancer patients, we are going to investigate whether circulating tumor DNA (ctDNA) detection can reflect the tumor response to neoadjuvant chemotherapy (NCT) and detect minimal residual disease after surgery.

Detailed description: Breast cancer is the most common malignant tumor in women worldwide, and chemotherapy is still the main method of breast cancer treatment. And for locally advanced breast cancer patients, neoadjuvant chemotherapy can further improve treatment efficacy, improve prognosis and increase the rate of breast conserving surgery. The persistence of a minimal residual disease at distant sites after the treatment of a localized breast cancer is a key parameter for posttreatment survival but cannot be reliably assessed by the current biological or radiological tools. Therefore, the prediction of the chemotherapy efficacy is very important. ctDNA, corresponds to fragmented DNA released into the blood stream by tumor masses, the detection and quantification of circulating tumor DNA (ctDNA) is a very promising tool that can assess tumor burden, response to therapy, and minimal residual disease. In this study, we wil collect breast cancer cases treated with neoadjuvant chemotherapy, draw blood and evaluate the efficacy each time before chemotherapy and after surgery, then measure the concentration of ctDNA in each sample. We will also analyze the demographic data,basic treatment and follow-up data including relapse, metastasis and survival.

Eligibility criteria: Inclusion Criteria:

* Patients pre- or post-menopausal must have histologically confirmed early stage/locally advanced invasive breast cancer;
* Tumor size ≥ 0.5cm (clinical or radiographic measurements);
* Any nodal status allowed;
* Age \> 18 years old;
* Felt to be a possible candidate for neoadjuvant systemic therapy by their treating physician;
* ECOG score\<=2;

Exclusion Criteria:

* Known metastatic disease;
* With serious heart, lung, liver diseases;
* Poor cardiac function;
* Pregnant;
* Patients with other malignant tumor or treated before;

Primary outcomes:
measure: The concentration of circulating DNA(ctDNA)
timeFrame: From date of neoadjuvant chemotherapy decided until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Jianjun He, PhD
role: PRINCIPAL_INVESTIGATOR
References: