Breast Cancer Treatment Based on Organ-like Culture

Sensitivity Detection and Drug Resistance Mechanism of Breast Cancer Therapeutic Drugs Based on Organ-like Culture

Based on the breast cancer organ platform, this experiment establishes a drug sensitivity test method that is closer to the body tumor in breast cancer, provides a basis for the accurate treatment of breast cancer, and discusses the possible mechanism of breast cancer drug resistance.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer Organoids
• Intervention / Treatment: Drug: Gemcitabine; Drug: Carboplatin; Drug: Trastuzumab; Drug: Doxorubicin Hydrochloride; Drug: Epirubicin hydrochloride; Drug: Fluorouracil; Drug: Paclitaxel; Drug: Cisplatin; Drug: Recombinant Human Endostatin; Drug: Pirarubicin hydrochloride; Drug: Pyrrolidine; Drug: Ixabepilone; Drug: Tamoxifen citrate; Drug: Vinorelbine tartrate; Drug: Methotrexate; Drug: Eribulin mesylate; Drug: Toremifene citrate; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane; Drug: Fulvestrant; Drug: Olaparib; Drug: Bevacizumab; Drug: Apatinib mesylate; Drug: Pattozumab; Drug: Capecitabine; Drug: Ear particles; Drug: Aidi Injection; Drug: Cyclophosphamide

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China
      • JingSu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

With the prolongation of human life and lifestyle changes, the incidence and mortality of cancer has increased year by year. Since 2010, cancer has become the leading cause of death. Among women, the incidence of breast cancer is the highest, and it shows a growing trend, which seriously threatens women's health. Breast cancer has a high degree of tumor heterogeneity, which leads to a great difference in sensitivity to chemotherapy among affected individuals. The drug resistance after chemotherapy leads to poor prognosis. Therefore, screening for breast cancer tumor cells is sensitive to chemotherapy. Molecular level studies of drug resistance are necessary.

Description

Inclusion Criteria:

Patients with breast cancer and the largest tumor diameter ≥ 3cm No previous chemotherapy regimen age 18-65 years old Can obtain the tumor tissue specimens required for culture Heart, liver, kidney and bone marrow hematopoietic function is good Know and sign the informed consent form

Exclusion Criteria:

Pregnant or lactating women Also suffering from other cancer patients There are serious uncontrolled medical diseases or acute infections Those who are known to be allergic to this study drug or a variety of previous drugs The patient cannot understand the purpose of the study or disagree with the requirements of the study.

Other investigators believe that patients who are not suitable for this study group

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HER2+ Breast Cancer	Drug: Gemcitabine; Gemcitabine injection; Drug: Carboplatin; Carboplatin injection; Drug: Trastuzumab; Trastuzumab Injection; Drug: Doxorubicin Hydrochloride; Doxorubicin Hydrochloride Injection; Drug: Epirubicin hydrochloride; Epirubicin hydrochloride injection; Drug: Fluorouracil; Fluorouracil injection; Drug: Paclitaxel; Paclitaxel injection; Drug: Cisplatin; Cisplatin injection; Drug: Recombinant Human Endostatin; Recombinant Human Endostatin Injection; Drug: Pirarubicin hydrochloride; Pirarubicin hydrochloride injection; Drug: Pyrrolidine; Pyrrolidine tablets; Drug: Ixabepilone; Ixapilone Injection; Drug: Tamoxifen citrate; Tamoxifen citrate tablets; Drug: Vinorelbine tartrate; Vinorelbine tartrate injection; Drug: Methotrexate; Methotrexate injection; Drug: Eribulin mesylate; Eribulin mesylate injection; Drug: Toremifene citrate; Toremifene citrate tablets; Drug: Anastrozole; Anastrozole tablets; Drug: Letrozole; Letrozole tablets; Drug: Exemestane; Exemestane tablets; Drug: Fulvestrant; Fulvestrant injection; Drug: Olaparib; Olapani pill; Drug: Bevacizumab; Bevacizumab injection; Drug: Apatinib mesylate; Apatinib mesylate tablets; Drug: Pattozumab; Pattozumab injection; Drug: Capecitabine; Capecitabine tablets; Drug: Ear particles; Ear particles; Drug: Aidi Injection; Aidi Injection; Drug: Cyclophosphamide; Cyclophosphamide injection
ER+ Breast Cancer	Drug: Gemcitabine; Gemcitabine injection; Drug: Carboplatin; Carboplatin injection; Drug: Trastuzumab; Trastuzumab Injection; Drug: Doxorubicin Hydrochloride; Doxorubicin Hydrochloride Injection; Drug: Epirubicin hydrochloride; Epirubicin hydrochloride injection; Drug: Fluorouracil; Fluorouracil injection; Drug: Paclitaxel; Paclitaxel injection; Drug: Cisplatin; Cisplatin injection; Drug: Recombinant Human Endostatin; Recombinant Human Endostatin Injection; Drug: Pirarubicin hydrochloride; Pirarubicin hydrochloride injection; Drug: Pyrrolidine; Pyrrolidine tablets; Drug: Ixabepilone; Ixapilone Injection; Drug: Tamoxifen citrate; Tamoxifen citrate tablets; Drug: Vinorelbine tartrate; Vinorelbine tartrate injection; Drug: Methotrexate; Methotrexate injection; Drug: Eribulin mesylate; Eribulin mesylate injection; Drug: Toremifene citrate; Toremifene citrate tablets; Drug: Anastrozole; Anastrozole tablets; Drug: Letrozole; Letrozole tablets; Drug: Exemestane; Exemestane tablets; Drug: Fulvestrant; Fulvestrant injection; Drug: Olaparib; Olapani pill; Drug: Bevacizumab; Bevacizumab injection; Drug: Apatinib mesylate; Apatinib mesylate tablets; Drug: Pattozumab; Pattozumab injection; Drug: Capecitabine; Capecitabine tablets; Drug: Ear particles; Ear particles; Drug: Aidi Injection; Aidi Injection; Drug: Cyclophosphamide; Cyclophosphamide injection
Triple Negative Breast Cancer	Drug: Gemcitabine; Gemcitabine injection; Drug: Carboplatin; Carboplatin injection; Drug: Trastuzumab; Trastuzumab Injection; Drug: Doxorubicin Hydrochloride; Doxorubicin Hydrochloride Injection; Drug: Epirubicin hydrochloride; Epirubicin hydrochloride injection; Drug: Fluorouracil; Fluorouracil injection; Drug: Paclitaxel; Paclitaxel injection; Drug: Cisplatin; Cisplatin injection; Drug: Recombinant Human Endostatin; Recombinant Human Endostatin Injection; Drug: Pirarubicin hydrochloride; Pirarubicin hydrochloride injection; Drug: Pyrrolidine; Pyrrolidine tablets; Drug: Ixabepilone; Ixapilone Injection; Drug: Tamoxifen citrate; Tamoxifen citrate tablets; Drug: Vinorelbine tartrate; Vinorelbine tartrate injection; Drug: Methotrexate; Methotrexate injection; Drug: Eribulin mesylate; Eribulin mesylate injection; Drug: Toremifene citrate; Toremifene citrate tablets; Drug: Anastrozole; Anastrozole tablets; Drug: Letrozole; Letrozole tablets; Drug: Exemestane; Exemestane tablets; Drug: Fulvestrant; Fulvestrant injection; Drug: Olaparib; Olapani pill; Drug: Bevacizumab; Bevacizumab injection; Drug: Apatinib mesylate; Apatinib mesylate tablets; Drug: Pattozumab; Pattozumab injection; Drug: Capecitabine; Capecitabine tablets; Drug: Ear particles; Ear particles; Drug: Aidi Injection; Aidi Injection; Drug: Cyclophosphamide; Cyclophosphamide injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of cell viability	1. The organ-like organ was assayed for cell viability using CellTiter Glo 3D reagent, and the curve was used to obtain a half-inhibitory concentration range. The dose was adjusted according to the half-inhibition concentration range to obtain an accurate half-inhibitory concentration.	8 weeks before neoadjuvant chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of in vitro model drug sensitivity	2. In vitro model drug sensitivity: sensitive and insensitive	8 weeks before neoadjuvant chemotherapy
Clinical efficacy assessment according to RECIST criteria	Clinical efficacy evaluation according to RECIST criteria: imaging ultrasonography, histological pathology.	8 weeks before neoadjuvant chemotherapy

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Anticipated): December 15, 2021
• Study Completion (Anticipated): December 15, 2021

Study Registration Dates

• First Submitted: March 30, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Drug sensitivity experiment; Resistance mechanism research
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; Poly(ADP-ribose) Polymerase Inhibitors; Antibiotics, Antineoplastic; Hormone Antagonists; Bone Density Conservation Agents; Anticoagulants; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Estrogen Receptor Antagonists; Reproductive Control Agents; Chelating Agents; Sequestering Agents; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Calcium Chelating Agents; Gemcitabine; Cyclophosphamide; Carboplatin; Trastuzumab; Fluorouracil; Olaparib; Capecitabine; Epirubicin; Letrozole; Fulvestrant; Bevacizumab; Doxorubicin; Liposomal doxorubicin; Vinorelbine; Methotrexate; Tamoxifen; Apatinib; Anastrozole; Exemestane; Citric Acid; Sodium Citrate; Endostatins; Pirarubicin; Toremifene
• Other Study ID Numbers: KY20182079-F-1

Drug and device information, study documents

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