Clinical Application of CTDNA in Operable Breast Cancer Patients

Study Overview
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Brief Summary
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Our study aims to evaluate the possibility of clinical application of CTDNA detection in samples or peripheral blood of breast cancer patients, so as to act as the new techniques or indicators of early diagnosis, therapy efficiency, or postoperative surveillance of breast cancer.

Official Title
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Clinical Application of CTDNA in Operable Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Neoadjuvant chemotherapy before surgery
* Procedure: Surgery followed by adjuvant chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures. Age of at least 18 and at most 70 years. Performance status (Karnofsky-Index) >80%. Chemotherapy is necessary before or after surgery. No clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated. Life expectancy of at least 2 years, disregarding the diagnosis of cancer. Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution. Patients must be available for and compliant to treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating center. Exclusion Criteria: Known hypersensitivity reaction to the investigational compounds or incorporated substances. Local recurrence and/or metastasis of breast cancer. No need of chemotherapy. Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration. Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix) Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study. Concurrent treatment with other experimental drugs or any other anti-cancer therapy. Males.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neoadjuvant chemotherapy<br>ctDNA of operable breast cancer patients with neoadjuvant chemotherapy before surgery in different periods: before neo-chemotherapy, during neo-chemotherapy, on surgery day, after surgery and follow-up time. | Procedure: Neoadjuvant chemotherapy before surgery<br>* The operable breast cancer patients takes neoadjuvant chemotherapy before surgery.<br>|
| Surgery<br>ctDNA of operable breast cancer patients with surgery followed by adjuvant chemotherapy in different periods: on surgery day, after surgery, before adjuvant chemotherapy, during adjuvant chemotherapy, and follow-up time. | Procedure: Surgery followed by adjuvant chemotherapy<br>* The operable breast cancer patients takes surgery followed by adjuvant chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of ctDNA copies per milliliter in patients' peripheral blood | The number of ctDNA copies per milliliter in patients' peripheral blood of neoadjuvant chemotherapy group and surgery group in different periods | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, ctDNA, Neoadjuvant chemotherapy, Adjuvant chemotherapy