Clinical trial NCT06503380: Real-world Study on the Management of Hematological Toxicities Associated With Targeted Therapies for Breast Cancer
Official title: Real-world Study on the Management of Hematological Toxicities Associated With Targeted Therapies for Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematological Toxicity
Targeted Therapy
Breast Cancer
Keywords: Hematological toxicity
Targeted therapy
Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


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.

Primary outcomes:
measure: Incidence of cancer treatment induced neutropenia (CIN)
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Incidence of cancer therapy induced thrombocytopenia (CTIT)
timeFrame: Approximately 2 years
measure: Incidence of cancer related anemia (CRA)
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhi-Ming Shao
state: Not US/Canada
Study officials:
affiliation: Fudan University
name: Zhi-Ming Shao
role: PRINCIPAL_INVESTIGATOR
References: