Clinical Application of CTC in Operable Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Clinical Application of CTC in Operable Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03842176
• Other study ID #: PUMCH-BREAST-CTC
• Status: Recruiting
• Start date: July 2016
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: Peking Union Medical College Hospital
• Contact: Yidong Zhou, Doctor
• Phone: 86-010-69155200
• Email: zhouyd[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Neoadjuvant chemotherapy before surgery
The operable breast cancer patients takes neoadjuvant chemotherapy before surgery.
• Surgery followed by adjuvant chemotherapy
The operable breast cancer patients takes surgery followed by adjuvant chemotherapy.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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