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

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Fudan University

Status

Enrolling

Conditions

Breast Cancer
Targeted Therapy
Hematological Toxicity

Treatments

Other: No intervenrion.

Study type

Observational

Funder types

Other

Identifiers

NCT06503380
MA-CIM-RWS-001

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Group
Description:
1000 patients we are planning to observe will be included in one group.
Treatment:
Other: No intervenrion.

Trial contacts and locations

1

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Central trial contact

Zhi-Ming Shao; Peng Ji

Data sourced from clinicaltrials.gov

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