Clinical Study on Drug Sensitivity Verification or Prediction of Therapy for Breast Cancer by Patient-Derived Organoid Model

NCT03544047 | Unknown

• 1 other identifier: NCC201804007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, single arm, open and exploratory clinical study, with 50 cases planned for a period of 2 years. The purpose of this study is to evaluate the consistency and accuracy of Patient-Derived Organoid Model of breast cancer to predict the clinical efficacy of the drug, as well as the possibility of guiding the neoadjuvant chemotherapy.

Conditions

Organoid

Outcome Measures

Primary Outcomes (1)

• Overall Response rates (ORR)

  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 Outcomes (3)

• Surgical excision rate

  up to 36 months

• Pathologic complete respons (pCR) rate

  up to 36 months

• Disease-free survival (DFS)

  up to 36 months

Study Arms (1)

Experimental arm

EXPERIMENTAL

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).

Drug: Paclitaxel

Interventions

Paclitaxel DRUG

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).

Experimental arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

RECRUITING

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Fei Ma, Professor

CONTACT

8610-87787652; drmafei@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: June 1, 2018
• Study Start: January 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: December 11, 2018

Record last verified: 2018-05

Locations

CN (1)