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

NCT04059003 | Unknown DMC

• 1 other identifier: Shengjing-LJY03
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Biomarkers; Tumor; Positron Emission Tomography; Computed Tomography

Outcome Measures

Primary Outcomes (1)

• Efficacy of neoadjuvant chemotherapy

  The efficacy will be evaluated by the response evaluation criteria in solid tumors (RECIST) score, which is based on CT or X-ray results. (1) Complete response (CR): disappearance of all lesions; (2) partial response (PR): 30% decrease in sum of all target lesions in longest axis measurement; (3) stable disease (SD): the sum of the longest diameter of all lesions decreases but does not reach PR or increases but does not reach PD; (4) progressive disease (PD): 20% increase in the sum of the longest diameter or appearance of new lesions. SD: One or more non-target lesions and/or tumor markers are higher than normal and persistent.

  At 18 weeks

Secondary Outcomes (3)

• Efficacy of neoadjuvant chemotherapy

  At 6 and 12 weeks

• Detection of circulating tumor cells

  At 3 weeks of neoadjuvant chemotherapy

• Miller-Payne grading score

  Before and 18 weeks after chemotherapy

Study Arms (2)

Sensitivity group

100 patients will be assigned into sensitivity group according to the actual situation of them.

Drug: Taxanes or/and anthracycline-based therapy

Drug resistance group

100 patients will be assigned into drug resistance according to the actual situation of them.

Drug: Taxanes or/and anthracycline-based therapy

Interventions

Taxanes or/and anthracycline-based therapy DRUG

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.

Drug resistance group; Sensitivity group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Totally 200 patients who meet the inclusion and exclusion criteria will be consecutively enrolled in the trial and grouped according to their sensitivity.

You may qualify if:

• triple-negative breast cancer confirmed by breast biopsy;
• stage III breast cancer (IIIA-C) assessed by CT or MRI;
• neoadjuvant chemotherapy;
• informed consent of patients and their family members.

You may not qualify if:

• use of second-line chemotherapy regimen;
• bilateral breast cancer;
• inflammatory breast cancer;
• pregnant or breast-feeding;
• distant metastasis;
• a history of other cancers or chest radiotherapy;
• a history of abnormal blood test or other infectious symptoms.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (2)

Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute

Shengyang, Liaoning, 110042, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jianyi Li

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianyi Li

CONTACT

+8618940257177; sjbreast@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 16, 2019
• Study Start: November 1, 2019
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2024
• Last Updated: January 20, 2022

Record last verified: 2022-01

Locations

CN (2)