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

Recruiting

• Conditions: Hematological Toxicity; Targeted Therapy; Breast Cancer
• Interventions: Other: No intervenrion.

• Registration Number: NCT06503380
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-18
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-09
• Study Start: 2024-07-15
• Study First Posted: 2024-07-16
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2026-07-15
• Study Completion: 2027-06-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of cancer treatment induced neutropenia (CIN)	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 Outcome Measures

Name	Time	Method
Incidence of cancer therapy induced thrombocytopenia (CTIT)	Approximately 2 years	Characteristics and management of thrombocytopenia induced by targeted therapies of breast cancer.
Incidence of cancer related anemia (CRA)	Approximately 2 years	Characteristics and management of anemia induced by targeted therapies in breast cancer patients in the real world.

Trial Locations

Locations (1)

Zhi-Ming Shao; 🇨🇳 Shanghai, Not US/Canada, China