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

July 30, 2024 updated by: Zhimin Shao, Fudan University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Not US/Canada
      • Shanghai, Not US/Canada, China, 200032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group
1000 patients we are planning to observe will be included in one group.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cancer therapy induced thrombocytopenia (CTIT)
Time Frame: Approximately 2 years
Characteristics and management of thrombocytopenia induced by targeted therapies of breast cancer.
Approximately 2 years
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.
Approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Zhi-Ming Shao, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2024

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

June 10, 2027

Study Registration Dates

First Submitted

June 18, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-CIM-RWS-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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