Comparison of pCR Rate After Neadjuvant Chemotherapy Guided by Result of in Vitro Cell Culture Drug Sensitivity or Physician's Choice
Primary Purpose
Breast Cancer, Neoadjuvant Chemotherapy, Drug Effect
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
treatment of drug screening
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- invasive breast cancer candidate for neoadjuvant chemotherapy normal liver and renal function agreed to participate in this experiment
Exclusion Criteria:
- inflammatory breast cancer patients can not receive operation after neoadjuvant chemotherapy distant metastasis
Sites / Locations
- Peking University People'S Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
treatment of physician's choice
treatment of drug screening
Arm Description
Patients in this arm will receive neoadjuvant chemotherapy according physician's choice.
Patients in this arm will receive neoadjuvant chemotherapy according results of drug screening vitro.
Outcomes
Primary Outcome Measures
pCR rate of neoadjuvant chemotherapy
compare which group would have higher pCR rate
Secondary Outcome Measures
Full Information
NCT ID
NCT04130750
First Posted
October 13, 2019
Last Updated
October 15, 2019
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04130750
Brief Title
Comparison of pCR Rate After Neadjuvant Chemotherapy Guided by Result of in Vitro Cell Culture Drug Sensitivity or Physician's Choice
Official Title
Comparison of pCR Rate After Neadjuvant Chemotherapy Guided by Result of in Vitro Cell Culture Drug Sensitivity or Physician's Choice
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2019 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Neoadjuvant chemotherapy is an important treatment for breast cancer patients. Patients with triple negative or Her2 enriched subtype who achieved pCR after neoadjuvant chemotherapy would have longer survival. But the overall pCR rate of breast cancer was about 20%. So, different methods have tried to improve pCR rate.Drug sensitivity screening in vitro for different chemotherapy drugs was a promising method for improving pCR rate. But there was no method could select effective drugs accurately for breast cancer patients until now. This study will explore whether drug screening by culturing breast cancer cells in vitro from breast cancer tissue could improve pCR rate compared with traditional neoadjuvant chemotherapy. Breast cancer patients who were candidates for neoadjuvant chemotherapy will be allocated two group. One group will receive neoadjuvant cheotherapy according physician's choices. Another group will receive neoadjuvant chemotherapy according results of drug sensitivity results by in vitro cell culture. pCR rate will be compared between two groups to explore whether drug sensitivity screening could improve pCR rate.
Detailed Description
Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be resectable and improve breast conservation rate. Patients with triple negative or Her2 enriched subtype who achieved pCR after neoadjuvant chemotherapy would have better survival. But the overall pCR rate of breast cancer was about 20%. And patients with luminal like subtype were less reactive for neoadjuvant chemotherapy. Improving pCR rate maybe could achieve better survival. So, different methods have tried to improve pCR rate.Drug sensitivity screening in vitro for different chemotherapy drugs was a promising method for improving pCR rate. But there was no method could select effective drugs accurately until now. This study will explore whether drug screening by culturing breast cancer cells in vitro from breast cancer tissue could improve pCR rate compared with neoadjuvant chemotherapy depend on physician's choice. 200 breast cancer patients who were candidates for neoadjuvant chemotherapy will be allocated to two group. One group with 100 patients will receive neoadjuvant cheotherapy according physician's choices. Another group with 100 patients will receive neoadjuvant chemotherapy according results of drug sensitivity results by in vitro cell culture. pCR rate will be compared between two groups to explore whether drug sensitivity screening could improve pCR rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neoadjuvant Chemotherapy, Drug Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment of physician's choice
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive neoadjuvant chemotherapy according physician's choice.
Arm Title
treatment of drug screening
Arm Type
Experimental
Arm Description
Patients in this arm will receive neoadjuvant chemotherapy according results of drug screening vitro.
Intervention Type
Combination Product
Intervention Name(s)
treatment of drug screening
Intervention Description
Patients in experimental group will receive a drug screening in vitro to select sensitive chemotherapy drug. And neoadjuvant chemotherapy will be performed according the results of drug screening.
Primary Outcome Measure Information:
Title
pCR rate of neoadjuvant chemotherapy
Description
compare which group would have higher pCR rate
Time Frame
through study completion, an average of 2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
invasive breast cancer candidate for neoadjuvant chemotherapy normal liver and renal function agreed to participate in this experiment
Exclusion Criteria:
inflammatory breast cancer patients can not receive operation after neoadjuvant chemotherapy distant metastasis
Facility Information:
Facility Name
Peking University People'S Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of pCR Rate After Neadjuvant Chemotherapy Guided by Result of in Vitro Cell Culture Drug Sensitivity or Physician's Choice
We'll reach out to this number within 24 hrs