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Breast Cancer Treatment Based on Organ-like Culture

  • Clinicaltrials.gov identifier

    NCT03925233

  • Recruitment Status

    Enrolling by invitation

  • First Posted

    April 24, 2019

  • Last update posted

    April 24, 2019

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:Breast Cancer Organoids
  • Intervention/Treatment: Drug: Gemcitabine
    Drug: Cisplatin
    Drug: Trastuzumab
    Drug: Doxorubicin Hydrochloride
    Drug: Epirubicin hydrochloride
    Drug: Fluorouracil
    Drug: Paclitaxel
    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
  • Phase: N/A

Detailed Description

N/A

Study Design

  • 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 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2021

Groups and Cohorts

Groups/Cohorts Intervention/treatment
: 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
: 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
: 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: 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.

Eligibility Criteria

  • Ages Eligible for Study: 18 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

Contacts and Locations

Contacts

Locations

China, Shaanxi
JingSu
Xi'an

Sponsors and Collaborators

Xijing Hospital

More Information

  • Responsible Party: Xijing Hospital
  • ClinicalTrials.gov Identifier: NCT03925233 History of Changes
  • 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
  • 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: Breast Neoplasms