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Breast Cancer Treatment Based on Organ-like Culture

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ClinicalTrials.gov Identifier: NCT03925233
Recruitment Status : Enrolling by invitation
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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
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

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Study Type : Observational
Estimated 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 : January 2, 2019
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Detection of cell viability [ Time Frame: 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 :
  1. Detection of in vitro model drug sensitivity [ Time Frame: 8 weeks before neoadjuvant chemotherapy ]
    2. In vitro model drug sensitivity: sensitive and insensitive

  2. Clinical efficacy assessment according to RECIST criteria [ Time Frame: 8 weeks before neoadjuvant chemotherapy ]
    Clinical efficacy evaluation according to RECIST criteria: imaging ultrasonography, histological pathology.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925233


Locations
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China, Shaanxi
JingSu
Xi'an, Shaanxi, China
Sponsors and Collaborators
Xijing Hospital
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03925233    
Other Study ID Numbers: KY20182079-F-1
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xijing Hospital:
Drug sensitivity experiment
Resistance mechanism research
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Toremifene
Gemcitabine
Vinorelbine
Cyclophosphamide
Bevacizumab
Carboplatin
Doxorubicin
Liposomal doxorubicin
Fluorouracil
Capecitabine
Methotrexate
Trastuzumab
Letrozole
Apatinib
Epirubicin
Olaparib
Fulvestrant
Anastrozole
Exemestane
Endostatins
Pirarubicin
Citric Acid
Sodium Citrate
Antineoplastic Agents, Phytogenic