Toxicity, DrugNCT06558084
Real-World Clinical Outcomes and Toxicity in Metastatic Breast Cancer Patients Treated With First or Second Line CDK 4/6 Inhibitors and Endocrine Therapy
An observational study of Toxicity, Drug and Progression, Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
To assess CDK4/6i toxicity and effect on PFS in the Egyptian population Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Toxicity, Drug, Progression, Disease
- What is being tested?
- CDK4/6 Inhibitor
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jul 2022to 10 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast Cancer patients attending Ain Shams University Clinical Oncology and Nuclear Medicine Department breast clinic from July 2022 till December 2024
Who may be able to join
- 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
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
About this study
To assess CDK4/6i toxicity and effect on PFS in the Egyptian population
- Conditions
- Toxicity, Drug, Progression, Disease
- Being tested
- CDK4/6 Inhibitor
- Keywords
- Breast cancer, CDK4/6 inhibitor, toxicity, PFS
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Disease Progression, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDK4/6 InhibitorDrug
CDK4/6 inhibitor in first and second lines
| Study group | Role | What they receive |
|---|---|---|
| Metastatic breast cancer patients | metastatic breast cancer patient receiving CDK4/6i in 1st or 2nd line Receives: Drug: CDK4/6 Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effect
assess the toxicity profile
Measured: 2 years
Secondary outcomes (1)
PFS
PFS in patient receiving CDK4/6i in Egypt
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start6 Jul 2022
- Primary completion31 Jul 2024
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxicity, DrugStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Ali, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558084
- Sponsor's protocol ID
- CDKTOX2024
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Clinical Outcomes and Toxicity in Metastatic Breast Cancer Patients Treated With First or Second Line CDK 4/6 Inhibitors and Endocrine Therapy
- ClinicalTrials.gov ID
- NCT06558084
- Acronym / sponsor ID
- CDKTOX2024
- Conditions
- Toxicity, Drug, Progression, Disease
- Keywords
- Breast cancer, CDK4/6 inhibitor, toxicity, PFS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess CDK4/6i toxicity and effect on PFS in the Egyptian population
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic breast cancer patients | – | Drug: CDK4/6 Inhibitormetastatic breast cancer patient receiving CDK4/6i in 1st or 2nd line |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast Cancer patients attending Ain Shams University Clinical Oncology and Nuclear Medicine Department breast clinic from July 2022 till December 2024
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDK4/6 InhibitorCDK4/6 inhibitor in first and second lines | Drug | Metastatic breast cancer patients |
Primary outcome
Adverse effect
Time frame: 2 years
assess the toxicity profile
1 secondary outcome
PFS
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Toxicity, Drug and Progression, Disease, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse effect (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.