Breast Cancer Treatment Based on Organ-like Culture

Sponsor

Xijing Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03925233

Collaborator

(none)

300

Enrollment

Location

35.4

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Organoids	Drug: Trastuzumab Drug: Doxorubicin Hydrochloride Drug: Epirubicin hydrochloride Drug: Fluorouracil Drug: Paclitaxel Drug: Gemcitabine Drug: Cisplatin Drug: Recombinant Human Endostatin Drug: Pirarubicin hydrochloride Drug: Pyrrolidine Drug: Ixabepilone Drug: Tamoxifen citrate Drug: Vinorelbine tartrate Drug: Carboplatin 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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 2, 2019

Anticipated Primary Completion Date :

Dec 15, 2021

Anticipated Study Completion Date :

Dec 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
HER2+ Breast Cancer	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: Gemcitabine Gemcitabine 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: Carboplatin Carboplatin 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: Trastuzumab Trastuzumab Injection Drug: Doxorubicin Hydrochloride Doxorubicin Hydrochloride Injection Drug: Epirubicin hydrochloride Epirubicin hydrochloride injection Drug: Fluorouracil Fluorouracil injection Drug: Paclitaxel Paclitaxel injection Drug: Gemcitabine Gemcitabine 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: Carboplatin Carboplatin 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: Trastuzumab Trastuzumab Injection Drug: Doxorubicin Hydrochloride Doxorubicin Hydrochloride Injection Drug: Epirubicin hydrochloride Epirubicin hydrochloride injection Drug: Fluorouracil Fluorouracil injection Drug: Paclitaxel Paclitaxel injection Drug: Gemcitabine Gemcitabine 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: Carboplatin Carboplatin 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

Arm

Intervention/Treatment

HER2+ Breast Cancer

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: Gemcitabine

Gemcitabine 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: Carboplatin

Carboplatin 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: Trastuzumab

Trastuzumab Injection

Drug: Doxorubicin Hydrochloride

Doxorubicin Hydrochloride Injection

Drug: Epirubicin hydrochloride

Epirubicin hydrochloride injection

Drug: Fluorouracil

Fluorouracil injection

Drug: Paclitaxel

Paclitaxel injection

Drug: Gemcitabine

Gemcitabine 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: Carboplatin

Carboplatin 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: Trastuzumab

Trastuzumab Injection

Drug: Doxorubicin Hydrochloride

Doxorubicin Hydrochloride Injection

Drug: Epirubicin hydrochloride

Epirubicin hydrochloride injection

Drug: Fluorouracil

Fluorouracil injection

Drug: Paclitaxel

Paclitaxel injection

Drug: Gemcitabine

Gemcitabine 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: Carboplatin

Carboplatin 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

Outcome Measures

Primary Outcome Measures

Detection of cell viability [8 weeks before neoadjuvant chemotherapy]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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