NCT05767931

Brief Summary

This is a prospective, single-center, non-randomized, non-controlled study

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

March 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2025

Completed
Last Updated

March 14, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

March 1, 2023

Last Update Submit

March 2, 2023

Conditions

Invasive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • antitumor rate of multi-specific antibody in patient-derived organoids and PDX model

    Patient-derived organoids and PDX model

    24 months

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

invasive breast cancer

You may qualify if:

  • Women between 18 and 70 years old；
  • Primary lesion \>2cm on imaging examination, or suspected axillary lymph node metastasis on imaging examination；
  • Previous not received preoperative radiotherapy, chemotherapy, endocrine therapy, immunotherapy, or other anticancer treatments；
  • Subjects signed informed consent；

You may not qualify if:

  • A history of prior or concomitant malignancies;
  • Advanced stage breast cancer (stage IV)；
  • Suspected or confirmed lesion was surgically removed；
  • Patients were accompanied by severe organic diseases such as heart and cerebral disease, and liver and kidney disease.；

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

collection of biopsy specimen and surgical specimen from patients

Study Officials

  • Zhaoqing Fan

    Breast center at Peking University Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaoqing Fan, MD

CONTACT

+86-10-88197838zhqfan@sina.com

Study Design

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

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 14, 2023

Study Start

March 6, 2023

Primary Completion

November 6, 2024

Study Completion

March 6, 2025

Last Updated

March 14, 2023

Record last verified: 2023-02

Locations

CN(1)