A Multicenter, Open and Observational Real World Study on the Prognosis and Treatment in Young Women With Breast Cancer

NCT04970264 | Unknown

• 1 other identifier: YWBC-001
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, open and observational real world study. The main purpose of this study is to map the genomic variation map of young breast cancer patients in China, and to analyze the relationship between gene mutation and therapeutic effect of young breast cancer patients. The secondary purpose was to analyze the relationship between gene mutation and prognosis of young breast cancer patients. We expect to enroll 2000 young breast cancer patients (≤35 years old). All patients were detected by targeted next generation sequencing （NGS）(600+ gene panel). Clinical diagnosis, treatment and prognosis information were collected. The Stratification factors mainly include stage, molecular type and treatment method.

Conditions

Breast Cancer

Keywords

young women with breast cancer; gene mutation characteristics; prognosis

Outcome Measures

Primary Outcomes (1)

• PFS

  The time from the first medication at the beginning of treatment to the first disease progression or death from any cause

  5 years

Secondary Outcomes (2)

• OS

  5 years

• ORR

  5 years

Other Outcomes (1)

• AEs

  5 years

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

We expect to enroll 2000 young breast cancer patients (18-35 years old). All patients were detected by targeted next generation sequencing （NGS）(600+ gene panel). Subgroups were stratified according to different stages, treatment methods and pathological types. The gene mutation characteristics, treatment sensitive genes and prognosis gene spectrum of different groups and subgroups were studied.

You may qualify if:

• Histologically confirmed as breast cancer.
• The age of diagnosis was 18-35 years old.
• ECOG score was 0-2, and the expected survival time was more than 3 months.
• No serious complications; no liver, kidney, hematopoiesis dysfunction.
• Informed consent, and patients willing to long-term follow-up. -

You may not qualify if:

• weeks before the start of the study, the use of drugs other than the trial, or participate in another clinical study at the same time, or others with an impact on the results of this study.
• Having a clear history of neurological or mental disorders (including epilepsy or dementia).
• Patients have uncontrollable complications, including active infection, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, decompensated diabetes, uncontrollable hypertension or mental disorders.
• Pregnant or lactating female patients.
• HIV infected patients.
• Patients with other tumors.
• After comprehensive evaluation, the researchers believe that patients are not suitable for this study.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

TianJin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fresh tissue from surgery or puncture, or formalin-fixed paraffin-embedded (FFPE) sample

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hong MD Liu, professor

CONTACT

18622221169; lh713@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: July 21, 2021
• Study Start: April 1, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2025
• Last Updated: July 21, 2021

Record last verified: 2021-04

Locations

CN (1)