Clinical Application of CTC in Operable Breast Cancer Patients

The investigators aim to evaluate the possibility of clinical application of CTC 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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Neoadjuvant chemotherapy before surgery; Procedure: Surgery followed by adjuvant chemotherapy

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Ru Yao, Doctor; Phone Number: 86-10-69152001; Email: yaoru@pumch.cn
• Study Contact Backup: Name: Yidong Zhou, Doctor; Phone Number: 86-010-69155200; Email: zhouyd@pumch.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital
    • Principal Investigator: Yidong Zhou, Doctor
    • Contact: Yidong Zhou, Doctor; Phone Number: 86-010-69155200; Email: zhouyd@pumch.cn
    • Principal Investigator: Ru Yao, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Operable breast cancer patients who need chemotherapy before or after surgery.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neoadjuvant chemotherapy; CTC 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; The operable breast cancer patients takes neoadjuvant chemotherapy before surgery.
Surgery; CTC 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; The operable breast cancer patients takes surgery followed by adjuvant chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of CTC mRNA markers in patients' peripheral blood	The level of CTC mRNA markers in patients' peripheral blood of neoadjuvant chemotherapy group and surgery group in different periods	3 years

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Breast Cancer; Adjuvant chemotherapy; Neoadjuvant chemotherapy; CTC
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PUMCH-BREAST-CTC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No