Clinical trial NCT04130750: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Neoadjuvant Chemotherapy
Drug Effect
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: pCR rate of neoadjuvant chemotherapy
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People'S Hospital
state: Beijing
Study officials:
References: