Real-world Study on the Management of Hematological Toxicities Associated With Targeted Therapies for Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervenrion..
- Who it may be relevant to
- Registry conditions: Hematological Toxicity, Targeted Therapy, Breast Cancer. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Incidence of cancer treatment induced neutropenia (CIN) [Time frame: Approximately 2 years]
Secondary outcome measures (2)
- Incidence of cancer therapy induced thrombocytopenia (CTIT) [Time frame: Approximately 2 years]
- Incidence of cancer related anemia (CRA) [Time frame: Approximately 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Zhi-Ming Shao — Shanghai
Identifiers
NCT: NCT06503380 · MA-CIM-RWS-001