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Breast Cancer OrganoidsNCT03925233

Breast Cancer Treatment Based on Organ-like Culture

An observational study of Breast Cancer Organoids, run by Xijing Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Breast Cancer Organoids
What is being tested?
Trastuzumab, Doxorubicin Hydrochloride and Epirubicin hydrochloride
How many people
300 participants
Where
1 siteChina
Study dates
2 Jan 2019to 15 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • JingSu

    Xi'an, Shaanxi

Other trials in China

About this study

Official title: 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.

Being tested
Trastuzumab, Doxorubicin Hydrochloride, Epirubicin hydrochloride, Fluorouracil, Paclitaxel
Keywords
Drug sensitivity experiment, Resistance mechanism research

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrastuzumabDrug

    Trastuzumab Injection

  • Doxorubicin HydrochlorideDrug

    Doxorubicin Hydrochloride Injection

  • Epirubicin hydrochlorideDrug

    Epirubicin hydrochloride injection

  • FluorouracilDrug

    Fluorouracil injection

  • PaclitaxelDrug

    Paclitaxel injection

  • GemcitabineDrug

    Gemcitabine injection

  • CisplatinDrug

    Cisplatin injection

  • Recombinant Human EndostatinDrug

    Recombinant Human Endostatin Injection

  • Pirarubicin hydrochlorideDrug

    Pirarubicin hydrochloride injection

  • PyrrolidineDrug

    Pyrrolidine tablets

  • IxabepiloneDrug

    Ixapilone Injection

  • Tamoxifen citrateDrug

    Tamoxifen citrate tablets

  • Vinorelbine tartrateDrug

    Vinorelbine tartrate injection

  • CarboplatinDrug

    Carboplatin injection

  • MethotrexateDrug

    Methotrexate injection

  • Eribulin mesylateDrug

    Eribulin mesylate injection

  • Toremifene citrateDrug

    Toremifene citrate tablets

  • AnastrozoleDrug

    Anastrozole tablets

  • LetrozoleDrug

    Letrozole tablets

  • ExemestaneDrug

    Exemestane tablets

  • FulvestrantDrug

    Fulvestrant injection

  • OlaparibDrug

    Olapani pill

  • BevacizumabDrug

    Bevacizumab injection

  • Apatinib mesylateDrug

    Apatinib mesylate tablets

  • PattozumabDrug

    Pattozumab injection

  • CapecitabineDrug

    Capecitabine tablets

  • Ear particlesDrug

    Ear particles

  • Aidi InjectionDrug

    Aidi Injection

  • CyclophosphamideDrug

    Cyclophosphamide injection

Study groups in NCT03925233
Study groupRoleWhat they receive
HER2+ Breast CancerNot described
Receives: 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 CancerNot described
Receives: 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 CancerNot described
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 8 weeks before neoadjuvant chemotherapy

Secondary outcomes (2)

  1. Detection of in vitro model drug sensitivity

    1. In vitro model drug sensitivity: sensitive and insensitive

    Measured: 8 weeks before neoadjuvant chemotherapy

  2. Clinical efficacy assessment according to RECIST criteria

    Clinical efficacy evaluation according to RECIST criteria: imaging ultrasonography, histological pathology.

    Measured: 8 weeks before neoadjuvant chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2019
  2. Study start2 Jan 2019
  3. Primary completion15 Dec 2021 (estimated)
  4. Study completion15 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03925233
Sponsor's protocol ID
KY20182079-F-1
Status last verified
Mar 2019
First submitted
30 Mar 2019
Last updated
24 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer Organoids, run by Xijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection of cell viability (time frame: 8 weeks before neoadjuvant chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03925233.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.

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