Real-world Study on the Management of Hematological Toxicities Associated With Targeted Therapies for Breast Cancer

NCT ID: NCT06503380

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-15

Study Completion Date

2027-06-10

Brief Summary

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This multicenter, real-world, observational study will retrospectively and prospectively collect real-world data related to the investigational drugs. We plan to observe 1000 patients and collect data on treatment cycles N and N+1 of the targeted therapies. Retrospective data collection is based on existing patient diagnosis and treatment records, collecting information on patients who have completed two treatment cycles before January 1, 2024. Prospective data collection is based on routine clinical treatment during the study period, collected until the end of the next cycle of treatment or early termination of the study. To observe the disease characteristics and management mode of hematological toxicity related to targeted therapies of breast cancer, and explore the possible related factors of hematological toxicity, such as age, disease subtype, cancer stage, targeted therapy regimens, etc. This study will respect the medication choices of researchers in the study, without specifying which medication to choose for treatment, dosage, mode of administration (including single drug, combination therapy, or sequential therapy), and duration of administration.

Detailed Description

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Conditions

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Hematological Toxicity Targeted Therapy Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Group

1000 patients we are planning to observe will be included in one group.

No intervenrion.

Intervention Type OTHER

This study will respect the medication choices of researchers in the study, without specifying which medication to choose for treatment, dosage, mode of administration (including single drug, combination therapy, or sequential therapy), and duration of administration.

Interventions

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No intervenrion.

This study will respect the medication choices of researchers in the study, without specifying which medication to choose for treatment, dosage, mode of administration (including single drug, combination therapy, or sequential therapy), and duration of administration.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* · The patients signed the informed consent and voluntarily participated in the study.

* A definite diagnosis of any type of breast cancer.
* Receiving or has completed targeted therapies.
* Investigator judged that the patient need to receive or had received treatment or prevention for CTIT, CIN or CRA induced by targeted therapies.

Exclusion Criteria

* · Pregnant or lactating women.

* Failure to understand the study or to obtain informed consent.
* The investigator determined other situations that are not suitable for inclusion.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zhimin Shao

Director of General Surgery of Fudan Shanghai Cancer Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhi-Ming Shao

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Zhi-Ming Shao

Shanghai, Not US/Canada, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhi-Ming Shao

Role: CONTACT

+86-021-64175590

Peng Ji

Role: CONTACT

+86-021-64175590

Facility Contacts

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Zhi-Ming Shao

Role: primary

Other Identifiers

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MA-CIM-RWS-001

Identifier Type: -

Identifier Source: org_study_id

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