Breast Cancer Treatment Based on Organ-like Culture

NCT03925233 | Unknown FDA Drug

• 1 other identifier: KY20182079-F-1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Organoids

Keywords

Drug sensitivity experiment; Resistance mechanism research

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Detection of in vitro model drug sensitivity

  8 weeks before neoadjuvant chemotherapy

• Clinical efficacy assessment according to RECIST criteria

  8 weeks before neoadjuvant chemotherapy

Study Arms (3)

HER2+ Breast Cancer

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

ER+ Breast Cancer

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

Triple Negative Breast Cancer

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

Interventions

Trastuzumab DRUG

Trastuzumab Injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Doxorubicin Hydrochloride DRUG

Doxorubicin Hydrochloride Injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Epirubicin hydrochloride DRUG

Epirubicin hydrochloride injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Fluorouracil DRUG

Fluorouracil injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Paclitaxel DRUG

Paclitaxel injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Gemcitabine DRUG

Gemcitabine injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Cisplatin DRUG

Cisplatin injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Recombinant Human Endostatin DRUG

Recombinant Human Endostatin Injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Pirarubicin hydrochloride DRUG

Pirarubicin hydrochloride injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Pyrrolidine DRUG

Pyrrolidine tablets

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Ixabepilone DRUG

Ixapilone Injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Tamoxifen citrate DRUG

Tamoxifen citrate tablets

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Vinorelbine tartrate DRUG

Vinorelbine tartrate injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Carboplatin DRUG

Carboplatin injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Methotrexate DRUG

Methotrexate injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Eribulin mesylate DRUG

Eribulin mesylate injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Toremifene citrate DRUG

Toremifene citrate tablets

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Anastrozole DRUG

Anastrozole tablets

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Letrozole DRUG

Letrozole tablets

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Exemestane DRUG

Exemestane tablets

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Fulvestrant DRUG

Fulvestrant injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Olaparib DRUG

Olapani pill

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Bevacizumab DRUG

Bevacizumab injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Apatinib mesylate DRUG

Apatinib mesylate tablets

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Pattozumab DRUG

Pattozumab injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Capecitabine DRUG

Capecitabine tablets

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Ear particles DRUG

Ear particles

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Aidi Injection DRUG

Aidi Injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Cyclophosphamide DRUG

Cyclophosphamide injection

ER+ Breast Cancer; HER2+ Breast Cancer; Triple Negative Breast Cancer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

JingSu

Xi'an, Shaanxi, China

Location

MeSH Terms

Interventions

Trastuzumab; Doxorubicin; Epirubicin; Fluorouracil; Paclitaxel; Gemcitabine; Cisplatin; Endostatins; pirarubicin; pyrrolidine; ixabepilone; Tamoxifen; Vinorelbine; Carboplatin; Methotrexate; eribulin; Toremifene; Anastrozole; Letrozole; exemestane; Fulvestrant; olaparib; Bevacizumab; apatinib; Capecitabine; Cyclophosphamide

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Coordination Complexes; Aminopterin; Pterins; Pteridines; Nitriles; Triazoles; Azoles; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2019
• First Posted: April 24, 2019
• Study Start: January 2, 2019
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: April 24, 2019

Record last verified: 2019-03

Locations

CN (1)