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

NCT06503380 | Recruiting

• 1 other identifier: MA-CIM-RWS-001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematological Toxicity; Targeted Therapy; Breast Cancer

Keywords

Hematological toxicity; Targeted therapy; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of cancer treatment induced neutropenia (CIN)

  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.

  Approximately 2 years

Secondary Outcomes (2)

• Incidence of cancer therapy induced thrombocytopenia (CTIT)

  Approximately 2 years

• Incidence of cancer related anemia (CRA)

  Approximately 2 years

Study Arms (1)

Group

1000 patients we are planning to observe will be included in one group.

Other: No intervenrion.

Interventions

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.

Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• · 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.

You may not qualify if:

• · Pregnant or lactating women.
• Failure to understand the study or to obtain informed consent.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhi-Ming Shao

Shanghai, Not US/Canada, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhi-Ming Shao

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi-Ming Shao

CONTACT

+86-021-64175590; zhi_ming_shao@163.com

Peng Ji

CONTACT

+86-021-64175590; JIPENG_1010@163.COM

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of General Surgery of Fudan Shanghai Cancer Center

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 16, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): June 10, 2027
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

CN (1)