NCT06558084Completed
Real-World Clinical Outcomes and Toxicity in Metastatic Breast Cancer Patients Treated With First or Second Line CDK 4/6 Inhibitors and Endocrine Therapy
Source: ClinicalTrials.gov · Last updated 16 Aug 2024
Brief summary (registry, in English)
To assess CDK4/6i toxicity and effect on PFS in the Egyptian population
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 64 (actual)
- First submitted
- 14 Aug 2024
- Start date
- 6 Jul 2022
- Primary completion date
- 31 Jul 2024
- Lead sponsor
- Ain Shams University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06558084
What you commit to
- Study type: Observational
- Participants enrolled: 64
- From 6 Jul 2022 to the primary completion date, 31 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with any CDK 4/6 inhibitor.
Other illness
- \- Male breast cancer patients
- 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.
Lab values
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ainshams University Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.