- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03544047
Clinical Study on Drug Sensitivity Verification or Prediction of Therapy for Breast Cancer by Patient-Derived Organoid Model
Study Overview
Detailed Description
After obtaining informed consent, patients who met the eligibility criteria underwent biopsy of the primary lesion or metastatic lesion (such as lymph node).Under the premise of ensuring normal detection requirements, a certain volume of fresh tumor tissues will be retained and used for the cultivation of Patient-Derived Organoid Model.If the organoid cultivation is not successful, the corresponding follow-up observation will be stopped.If the organoid cultivation is successful, drug sensitivity verification or prediction by Patient-Derived Organoid Model will be completed (final report will be available in about one month). During this period, the patient was first treated with paclitaxel (PTX) chemotherapy 3 cycles (2 weeks regimen) and Herceptin was treated in HER2 amplification patients. After 3 cycles, the efficacy was assessed according to the RECIST solid tumor evaluation standard (version 1.1), and the evaluation methods mainly included physical examination, ultrasound, CT and MRI.If the tumor continues to reduce in the first 3 cycles, continue paclitaxel chemotherapy for 3 cycles (6 weeks) and Herceptin was treated in HER2 amplification patients.If the evaluation of the curative effect is SD or PD, according to the result of drug sensitivity of the class organ, combined with the clinical practice, the doctor chooses the most sensitive treatment plan, and continues the 2 cycle treatment (6 weeks).After the completion of the evaluation, combined with the clinical situation, the next step is decided.For those who meet the conditions of the operation, the modified radical mastectomy or breast conserving surgery was performed after the neoadjuvant chemotherapy. The pCR status of the primary breast cancer and the axillary lymph nodes were evaluated after the operation. The adjuvant radiotherapy and endocrine therapy were given after the operation, and the long-term survival was observed.
Drug sensitivity tests include single drug and drug combination. The organs that are successfully cultured will be kept in liquid nitrogen for a specific time.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fei Ma, Professor
- Phone Number: 8610-87787652
- Email: drmafei@126.com
Study Locations
-
-
-
Beijing, China
- Recruiting
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
-
Contact:
- Binliang Liu, Postgraduate student
- Phone Number: +8618211125199
- Email: liubinliang_onco@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The age is more than 18 years old;
- Pathology and immunohistochemical diagnosis of stage II-III breast cancer patients;
- No prior treatment (such as anti-tumor therapy, immunotherapy, related surgery, etc.) may affect the outcome of the treatment;
- According to the RECIST standard, the lesion was measured (the diameter of the primary lesion was greater than 1.0cm or the short diameter of the lymph node was greater than 1.5cm);
- Metastatic lesions or primary lesions can obtain surgical tissue or adequate biopsy tissue;
- No clinical diagnosis of other malignancies, unstable complications or uncontrolled infection;
- ECOG PS score: 0-2 points;
- Life expectancy is greater than 6 month;
- The main organ function is normal;
- The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance.
Exclusion Criteria:
- Unable to obtain sufficient tumor organizer by operation or biopsy;
- Pregnant and lactating patients;
- Patients with peripheral nervous system disorder caused by disease or have significant mental disorders and history of central nervous system disorders;
- Patients with severe infections or active digestive tract ulcers need to be treated;
- Allergic to chemotherapy drugs or surgical contraindication;
- History of other malignant tumors;
- Severe liver disease (such as cirrhosis), cardiovascular disease, kidney disease, respiratory disease, blood system disease, or uncontrolled diabetes;
- Participating in or participating in other clinical trials within a month.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental arm
Patient was first treated with paclitaxel (PTX) chemotherapy 3 cycles (2 weeks regimen) and Herceptin was treated in HER2 amplification patients.
After 3 cycles.
If the tumor continues to reduce in the first 3 cycles, continue paclitaxel chemotherapy for 3 cycles (6 weeks) and Herceptin was treated in HER2 amplification patients.
If the evaluation of the curative effect is SD or PD, according to the result of drug sensitivity of the class organ, combined with the clinical practice, the doctor chooses the most sensitive treatment plan, and continues the 2 cycle treatment (6 weeks).
|
Patient was first treated with paclitaxel (PTX) chemotherapy 3 cycles (2 weeks regimen).
If the tumor continues to reduce in the first 3 cycles, continue paclitaxel chemotherapy for 3 cycles (6 weeks).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response rates (ORR)
Time Frame: up to 36 months
|
Defined as complete response (CR) + partial response (PR), assessed based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.
|
up to 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical excision rate
Time Frame: up to 36 months
|
After neoadjuvant chemotherapy, the ratio of patients who achieved surgical resection.
|
up to 36 months
|
Pathologic complete respons (pCR) rate
Time Frame: up to 36 months
|
pCR is defined as no infiltrating tumor cells in pathological examination in the primary breast and axillary lymph nodes.
|
up to 36 months
|
Disease-free survival (DFS)
Time Frame: up to 36 months
|
The period after curative treatment when no disease can be detected)
|
up to 36 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCC201804007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Organoid
-
Peking Union Medical College HospitalNot yet recruitingGynecologic Cancer | Organoid
-
Dong Bing ZhaoRecruitingGastric Cancer | Neoadjuvant Therapy | OrganoidChina
-
Centre Francois BaclesseRecruiting
-
University Medical Center GroningenRecruitingEsophageal Cancer | Chemoradiation | OrganoidNetherlands
-
Affiliated Hospital of Jiangnan UniversityRecruitingLung Cancer | OrganoidChina
-
University Hospital, GenevaRecruiting
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingOvarian Cancer | OrganoidChina
Clinical Trials on Paclitaxel
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Breast Carcinoma | Stage IV Breast Cancer AJCC v6 and v7 | Stage III Breast Cancer AJCC v7 | Stage IIIA Breast Cancer AJCC v7 | Stage IIIB Breast Cancer AJCC v7 | Stage IIIC Breast Cancer AJCC v7 | Metastatic Breast Carcinoma | Locally Advanced Breast CarcinomaUnited States
-
Anne NoonanNational Cancer Institute (NCI)RecruitingStage IV Pancreatic Cancer AJCC v8 | Metastatic Pancreatic AdenocarcinomaUnited States
-
Hutchison Medipharma LimitedSun Yat-sen UniversityActive, not recruitingAdvanced Gastric CancerChina
-
University of WashingtonNational Cancer Institute (NCI); Celgene CorporationCompletedRecurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung CancerUnited States
-
Shengjing HospitalRecruiting
-
CTI BioPharmaTerminatedNSCLCUnited States, Canada, Bulgaria, Romania, Russian Federation, Ukraine, Mexico, Argentina, Hungary, Poland, United Kingdom
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnRecurrent Bladder Urothelial Carcinoma | Stage IV Bladder Urothelial CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
CTI BioPharmaTerminated
-
Novartis PharmaceuticalsCompletedMetastatic or Locally Advanced Solid TumorsNetherlands, Spain, Germany, Switzerland, Belgium