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OpenTrials
Completed

NCT Number: NCT06558084

Real-World Clinical Outcomes and Toxicity in Metastatic Breast Cancer Patients Treated With First or Second Line CDK 4/6 Inhibitors and Endocrine Therapy

To assess CDK4/6i toxicity and effect on PFS in the Egyptian population

Completed

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Breast cancer patients aged 18 years old or more
  • Female patients
  • Histologically proven invasive breast cancer
  • Histologically proven HR-positive and HER2-negative breast cancer
  • Metastatic breast cancer (Stage 4 according to AJCC 8th edition 2017)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 3.
  • Adequate hematological and organs function
  • Patients receiving CDK 4/6 inhibitor combined with endocrine therapy(Aromatase inhibitors , GnRH agonists, fulvastrent). as a first or second line treatment

Exclusion criteria

  • - Male breast cancer patients
  • Patients in, visceral crisis (defined as : severe organ dysfunction, as assessed by signs and symptoms, laboratory studies and rapid progression of disease ) that are at risk of life threatening complication in the short term.
  • Prior treatment with any CDK 4/6 inhibitor.
  • History of any other cancer , unless in complete remission with no therapy for a minimum of 3 years.
  • Have active bacterial or fungal infection, or detectable viral infection.

Treatment and study plan

CDK4/6 inhibitor

Drug

CDK4/6 inhibitor in first and second lines

Primary outcomes

  1. Adverse effect

    Time frame: 2 years

    assess the toxicity profile

Secondary outcomes

  1. PFS

    Time frame: 2 years

    PFS in patient receiving CDK4/6i in Egypt

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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