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Recruiting

NCT Number: NCT06503380

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

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhi-Ming Shao

Shanghai, Not US/Canada, 200032, China

Location status: Recruiting

Location contact

Zhi-Ming Shao

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervenrion.

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.

Primary outcomes

  1. Incidence of cancer treatment induced neutropenia (CIN)

    Time frame: Approximately 2 years

    The occurrence, prevention, treatment of neutropenia associated with targeted therapies. The influence of different baseline characteristics of patients on treatment outcomes and efficacy and safety of drugs.

Secondary outcomes

  1. Incidence of cancer therapy induced thrombocytopenia (CTIT)

    Time frame: Approximately 2 years

    Characteristics and management of thrombocytopenia induced by targeted therapies of breast cancer.

  2. Incidence of cancer related anemia (CRA)

    Time frame: Approximately 2 years

    Characteristics and management of anemia induced by targeted therapies in breast cancer patients in the real world.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 16, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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