The Consistency of Drug Screening in Vitro and Neoadjuvant Chemotherapy Results in Breast Cancer Patients

NCT04131881 | Completed

• 1 other identifier: PKUPH10B002
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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 select effective drug before chemotherapy.Drug sensitivity screening in vitro for different chemotherapy drugs was a promising method. This study will explore whether drug screening by culturing breast cancer cells in vitro from breast cancer tissue could consistent with neoadjuvant chemotherapy in patients.40 breast cancer patients were recruited.The results of drug sensitivity in vitro and pathological evaluation after neoadjuvant chemotherapy were compared whether they were consistent.

Conditions

Breast Cancer; Drug Effect

Outcome Measures

Primary Outcomes (1)

• Consistency rate of drug sensitivity in vitro and in vivo

  Compute the percentage of patients whose drug sensitivity were consistent between in vitro and in vivo, as both were sensitive or insensitive.

  through study completion, an average of 2 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in this study were invasive early breast cancer patients who were candidate for neoadjuvant chemotherapy.

You may qualify if:

• invasive breast cancer candidates for neoadjuvant chemotherapy agreed to participate in this observative experiments could receive operation normal liver and renal function

You may not qualify if:

• inflammatory breast cancer recurrent breast cancer

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Peking University: collaborator

Study Sites (1)

Peking University People'S Hospital

Beijing, Beijing Municipality, 100044, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood sample were retention

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shu Wang, doctor

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: October 18, 2019
• Study Start: April 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)