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CTC Changes and Efficacy of Neoadjuvant Chemotherapy for Triple-negative Breast Cancer

NCT04059003 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2022-01-20

No results posted yet for this study

Summary

Chemotherapy before operation for malignant tumors can reduce the size of tumors to a certain extent, even eliminate micrometastases. Chemotherapy can also detect the sensitivity of chemotherapeutic drugs and create opportunities for breast-conserving or surgical treatment for patients. This may lead to high survival opportunities for triple-negative breast cancer patients who are not sensitive to targeted therapy or endocrine therapy. However, during neoadjuvant therapy, CT or MRI tests are needed to monitor the patient's condition. Therefore, if there is any deterioration, to consider changing the treatment regimen or immediately carrying out surgery is necessary. However, because of the need for multiple imaging examinations during neoadjuvant therapy, which will increase medical costs, to explore a cheaper examination method is necessary . Circulating tumor cells in peripheral blood are derived from the shedding of breast cancer lesions. Detection of these circulating tumor cells may monitor the therapeutic effect on breast cancer, and the cost of detecting circulating tumor cells is much lower than that of conventional PET-CT, which can obviously reduce the medical costs of patients. However, there is no clinical study on the changes of circulating tumor cells and the efficacy of neoadjuvant chemotherapy in the treatment of triple-negative breast cancer in and outside China.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Taxanes or/and anthracycline-based therapy

Taxanes or/and anthracycline-based therapy will be used in this group. That is, intravenous injection of 90 mg/m2 epirubicin (trade name: Pharmorubicin, Pfizer, Shanghai, China; drug approval number: H20100155) + 135 mg/m2 paclitaxel liposome (trade name: Taxotere, Sanofi (Hangzhou) Pharmaceutical Co., Ltd., Hangzhou, China; drug approval number: J20090104), every 3 weeks as a course of treatment. The efficacy will be evaluated every 2 courses. After the 6th course, mastectomy will be performed according to the patient's conditions.

Sponsors & Collaborators

  • Shengjing Hospital

    lead OTHER

Principal Investigators

  • Jianyi Li · Shengjing Hospital

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2023-08-31
Completion
2024-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04059003 on ClinicalTrials.gov