The Consistency of Drug Screening in Vitro and Neoadjuvant Chemotherapy Results in Breast Cancer Patients

The Consistency of Drug Sensitivity in Vitro and Neoadjuvant Chemotherapy Results in Vivo for Early Breast Cancer Patients

Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be resectable and improve breast conservation rate. Patients with triple negative or Her2 enriched subtype who achieved pCR after neoadjuvant chemotherapy would have better survival. But the overall pCR rate of breast cancer was about 20%. And patients with luminal like subtype were less reactive for neoadjuvant chemotherapy. Improving pCR rate maybe could achieve better survival. So, different methods have tried to select effective drug before chemotherapy.Drug sensitivity screening in vitro for different chemotherapy drugs was a promising method. This study will explore whether drug screening by culturing breast cancer cells in vitro from breast cancer tissue could consistent with neoadjuvant chemotherapy in patients.40 breast cancer patients were recruited.The results of drug sensitivity in vitro and pathological evaluation after neoadjuvant chemotherapy were compared whether they were consistent.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Drug Effect

Detailed Description

Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be resectable and improve breast conservation rate. Patients with triple negative or Her2 enriched subtype who achieved pCR after neoadjuvant chemotherapy would have better survival. But the overall pCR rate of breast cancer was about 20%. And patients with luminal like subtype were less reactive for neoadjuvant chemotherapy. Improving pCR rate maybe could achieve better survival. So, different methods have tried to select effective drug before chemotherapy.Drug sensitivity screening in vitro for different chemotherapy drugs was a promising method. This study will explore whether drug screening by culturing breast cancer cells in vitro from breast cancer tissue could consistent with neoadjuvant chemotherapy in patients.40 breast cancer patients who would receive neoadjuvant chemotherapy were recruited.Breast cancer tissues were obtained before chemotherapy. The breast cancer cells were cultured in unadhesive dishes. Chemotherapy drugs were put in dishes and drug sensitivity were evaluated. Patients received operation and pathological evaluationc after neoadjuvant chemotherapy. The results of drug sensitivity in vitro and pathological evaluation after neoadjuvant chemotherapy were compared whether they were consistent.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital

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

Patients in this study were invasive early breast cancer patients who were candidate for neoadjuvant chemotherapy.

Description

Inclusion Criteria:

• invasive breast cancer candidates for neoadjuvant chemotherapy agreed to participate in this observative experiments could receive operation normal liver and renal function

Exclusion Criteria:

• inflammatory breast cancer recurrent breast cancer

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consistency rate of drug sensitivity in vitro and in vivo	Compute the percentage of patients whose drug sensitivity were consistent between in vitro and in vivo, as both were sensitive or insensitive.	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Peking University
• Investigators: Principal Investigator: shu wang, doctor, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: October 13, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): October 18, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PKUPH10B002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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