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

NCT04130750 | Unknown Early Phase 1

• 1 other identifier: PKUPH10B001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Neoadjuvant Chemotherapy; Drug Effect

Outcome Measures

Primary Outcomes (1)

• pCR rate of neoadjuvant chemotherapy

  compare which group would have higher pCR rate

  through study completion, an average of 2 years

Study Arms (2)

treatment of physician's choice

ACTIVE COMPARATOR

Patients in this arm will receive neoadjuvant chemotherapy according physician's choice.

Combination Product: treatment of drug screening

treatment of drug screening

EXPERIMENTAL

Patients in this arm will receive neoadjuvant chemotherapy according results of drug screening vitro.

Combination Product: treatment of drug screening

Interventions

treatment of drug screening COMBINATION_PRODUCT

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.

treatment of drug screening; treatment of physician's choice

Eligibility Criteria

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

You may qualify if:

• invasive breast cancer candidate for neoadjuvant chemotherapy normal liver and renal function agreed to participate in this experiment

You may not qualify if:

• inflammatory breast cancer patients can not receive operation after neoadjuvant chemotherapy distant metastasis

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People'S Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: October 17, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 17, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)