Invasive Breast CancerNCT05767931
Development of Multi-specific Antibodies Based on Immune Microenvironment of Breast Cancer
An observational study of Invasive Breast Cancer, run by Peking University at 1 site in China.
Trial summary
This is a prospective, single-center, non-randomized, non-controlled study Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Invasive Breast Cancer
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2023to 6 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: invasive breast cancer
Who may be able to join
- 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；
Who cannot join
- 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.；
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Zhaoqing Fan, +86-10-88197838, zhqfan@sina.com
Zhaoqing Fan, MD
About this study
This is a prospective, single-center, non-randomized, non-controlled study
Read the detailed description
Immunotherapy with immune-checkpoint inhibitors (ICIs) has enabled a leap forward in the treatment of various types of cancer within the past decade. However,only 12.46% of patients with cancer are expected to respond to ICIs.Our team have recently developed a multi-specific antibody technology platform for the microenvironment of solid tumors.
In this study, we are going to study the tumor immune microenvironment of breast cancer patients by patient-derived organoids or PDX model，to design multi-specific antibody drugs for different tumor immune microenvironment，to look forward to improve the effectiveness of immunotherapy for breast cancer and solve the problem of drug resistance.
- Conditions
- Invasive Breast Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
antitumor rate of multi-specific antibody in patient-derived organoids and PDX model
Patient-derived organoids and PDX model
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start6 Mar 2023 (estimated)
- Primary completion6 Nov 2024 (estimated)
- Study completion6 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaoqing Fan, Principal investigator, Breast center at Peking University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767931
- Sponsor's protocol ID
- BC-P32
- Status last verified
- Feb 2023
- First submitted
- 1 Mar 2023
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Multi-specific Antibodies Based on Immune Microenvironment of Breast Cancer
- ClinicalTrials.gov ID
- NCT05767931
- Acronym / sponsor ID
- BC-P32
- Conditions
- Invasive Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 6 Mar 2023 (estimated)
- Primary completion
- 6 Nov 2024 (estimated)
- Study completion
- 6 Mar 2025 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-center, non-randomized, non-controlled study
Detailed description
Immunotherapy with immune-checkpoint inhibitors (ICIs) has enabled a leap forward in the treatment of various types of cancer within the past decade. However,only 12.46% of patients with cancer are expected to respond to ICIs.Our team have recently developed a multi-specific antibody technology platform for the microenvironment of solid tumors.
In this study, we are going to study the tumor immune microenvironment of breast cancer patients by patient-derived organoids or PDX model，to design multi-specific antibody drugs for different tumor immune microenvironment，to look forward to improve the effectiveness of immunotherapy for breast cancer and solve the problem of drug resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- invasive breast cancer
Key inclusion criteria (4 listed)
- 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；
Key exclusion criteria (4 listed)
- 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.；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
antitumor rate of multi-specific antibody in patient-derived organoids and PDX model
Time frame: 24 months
Patient-derived organoids and PDX model
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoqing Fan principal investigator
Breast center at Peking University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Breast Cancer, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaoqing Fan, MD (+86-10-88197838, zhqfan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antitumor rate of multi-specific antibody in patient-derived organoids and PDX model (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.