NCT04836156|RecruitingPhase 1/2
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Sponsor study identifier
interventional
46
1 country
1
Study Start
April 2, 2021
Actual (reported)Primary Completion
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Neoadjuvant treatment is an important treatment for early breast cancer patients. Patients with triple negative subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 negative patient was chemotherapy with combined drugs. However, not all patients benefit from chemotherapy but suffer from chemotherapy-related side effects. It was unknown for a patient who could benefit from which drug before chemotherapy. Drug sensitivity screening in vitro was a promising method for choosing chemotherapy. But there was no method could select effective drugs accurately for breast cancer patients until now. Previously, investigators developed a patient-derived tumor-like cell clusters in vitro culture technology. Feasibility for guiding clinical treatment by drug sensitivity screening based on this technology have been explored by preliminary exploration with a well corresponding. And the results have been published. This study will explore whether drug screening in vitro patient-derived tumor-like cell clusters from breast cancer tissue could be a method for selection of chemotherapy for her2 negative participants.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 28, 2021
Actual (reported)April 2, 2021
Actual (reported)April 8, 2021
Actual (reported)June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
pathological complete response(pCR)
ypT0/is, ypN0
up to 24 weeks
event-free survival (EFS)
5 years
invasive disease-free survival (IDFS)
5 years
objective response rate
up to 24 weeks
Patients with triple negative subtype will receive neoadjuvant chemotherapy based on PTC drug screening.
Patients with luminal like subtype will receive neoadjuvant chemotherapy based on PTC drug screening.
The choice of chemotherapy is based on the PTC drug sensitivity results.
Peking University People's Hospital
Beijing, China
Shu Wang, doctor
Peking University People's Hospital
First Submitted
March 28, 2021
First Posted
April 8, 2021
Study Start
April 2, 2021
Actual (reported)Primary Completion
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The choice of chemotherapy is based on the PTC drug sensitivity results.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 6, 2022
Record last verified: 2022-03
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Source: ClinicalTrials.gov.
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