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Comparison of pCR Rate After Neadjuvant Chemotherapy Guided by Result of in Vitro Cell Culture Drug Sensitivity or Physician's Choice

Comparison of pCR Rate After Neadjuvant Chemotherapy Guided by Result of in Vitro Cell Culture Drug Sensitivity or Physician's Choice

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04130750
Enrollment
200
Registered
2019-10-17
Start date
2019-12-31
Completion date
2021-12-31
Last updated
2019-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Drug Effect, Neoadjuvant Chemotherapy

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.

Interventions

COMBINATION_PRODUCTtreatment of drug screening

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.

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pCR rate of neoadjuvant chemotherapythrough study completion, an average of 2 yearscompare which group would have higher pCR rate

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026