Metastatic Breast CancerOCDMBCNCT07704801
CDK4/6 Inhibitors in Metastatic HR-Positive Breast Cancer
An observational study of Metastatic Breast Cancer, run by Sohag University at 1 site in Egypt.
Trial summary
This study is a retrospective review aimed at evaluating the real-world outcomes and clinical efficacy of CDK4/6 inhibitors (such as Palbociclib, Ribociclib, or Abemaciclib) in patients diagnosed with metastatic luminal A and luminal B breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- CDK4/6 inhibitors
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of female patients diagnosed with hormone receptor-positive, HER2-negative (Luminal A or Luminal B) metastatic breast cancer who were managed and treated with CDK4/6 inhibitors at Sohag University Hospital and SCI . Data will be extracted from their existing medical records.
Who may be able to join
- patients who are more than 18 years old at time of diagnosis and less than 80 years
- metastatic breast cancer luminal A and luminal B of either sex
Who cannot join
- patients diagnosed with double malignancy
- patients with incomplete medical records
- patients with organ failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RETROSPECTIVE STUDY OF OUTCOME OF CDK4/6 INHIBITORS IN METASTATIC LUMINAL A AND LUMINAL B BREAST CANCER
This study is a retrospective review aimed at evaluating the real-world outcomes and clinical efficacy of CDK4/6 inhibitors (such as Palbociclib, Ribociclib, or Abemaciclib) in patients diagnosed with metastatic luminal A and luminal B breast cancer. The study will assess how patients responded to these treatments based on their specific breast cancer subtype (Luminal A vs. Luminal B) by reviewing their medical records.
Read the detailed description
This is a retrospective, observational cohort study conducted at Sohag University Hospital].
The study will include medical records of female patients diagnosed with metastatic Luminal A and Luminal B breast cancer who received CDK4/6 inhibitors as part of their treatment regimen between 2021 and 2026 Data will be collected regarding Patient demographics and baseline clinical characteristics. Pathological features (Hormone receptor status and Ki-67 levels to differentiate Luminal A and B).
Treatment duration and response rates. Outcomes such as Progression-Free Survival (PFS) and Overall Survival (OS), as well as documented adverse effects.
The primary objective is to compare the clinical outcomes and effectiveness of CDK4/6 inhibitors between the Luminal A and Luminal B metastatic breast cancer subgroups in a real-world setting.
- Conditions
- Metastatic Breast Cancer
- Being tested
- CDK4/6 inhibitors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDK4/6 inhibitorsDrug
Retrospective evaluation of patients who received standard clinical doses of CDK4/6 inhibitors as part of their treatment regimen for metastatic luminal A and luminal B breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| luminal A subgroup | patients diagnosed with metastatic breast cancer Receives: Drug: CDK4/6 inhibitors | |
| luminal B subgroup | patients diagnosed with metastatic breast cancer Receives: Drug: CDK4/6 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Progression-free survival is defined as the time from initiation of CDK4/6 inhibitor therapy until documented disease progression or death from any cause.
Measured: Up to 4 years أو From initiation of CDK4/6 inhibitor therapy to disease progression or death, up to 4 years.
Progression-Free Survival (PFS)
PFS is defined as the time from the initiation of CDK4/6 inhibitor therapy to the date of documented disease progression or death from any cause, whichever occurs first.
Measured: From the date of therapy initiation up to 4 yrs
Progression-Free Survival (PFS)
PFS is defined as the time from the initiation of CDK4/6 inhibitor therapy to the date of documented disease progression or death from any cause, whichever occurs first.
Measured: From the date of therapy initiation up to 4 years (the period of retrospective medical records review).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Jan 2021
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abrar Mohamed Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704801
- Sponsor's protocol ID
- Soh-Med-26-6-5MS
- Acronym
- OCDMBC
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Individual data sharing
- No: regulations and hospital policies
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RETROSPECTIVE STUDY OF OUTCOME OF CDK4/6 INHIBITORS IN METASTATIC LUMINAL A AND LUMINAL B BREAST CANCER
- ClinicalTrials.gov ID
- NCT07704801
- Acronym / sponsor ID
- OCDMBC / Soh-Med-26-6-5MS
- Conditions
- Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 15 Jul 2026 (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.
This study is a retrospective review aimed at evaluating the real-world outcomes and clinical efficacy of CDK4/6 inhibitors (such as Palbociclib, Ribociclib, or Abemaciclib) in patients diagnosed with metastatic luminal A and luminal B breast cancer. The study will assess how patients responded to these treatments based on their specific breast cancer subtype (Luminal A vs. Luminal B) by reviewing their medical records.
Detailed description
This is a retrospective, observational cohort study conducted at Sohag University Hospital].
The study will include medical records of female patients diagnosed with metastatic Luminal A and Luminal B breast cancer who received CDK4/6 inhibitors as part of their treatment regimen between 2021 and 2026 Data will be collected regarding Patient demographics and baseline clinical characteristics. Pathological features (Hormone receptor status and Ki-67 levels to differentiate Luminal A and B).
Treatment duration and response rates. Outcomes such as Progression-Free Survival (PFS) and Overall Survival (OS), as well as documented adverse effects.
The primary objective is to compare the clinical outcomes and effectiveness of CDK4/6 inhibitors between the Luminal A and Luminal B metastatic breast cancer subgroups in a real-world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| luminal A subgroup | – | Drug: CDK4/6 inhibitorspatients diagnosed with metastatic breast cancer |
| luminal B subgroup | – | Drug: CDK4/6 inhibitorspatients diagnosed with metastatic breast cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of female patients diagnosed with hormone receptor-positive, HER2-negative (Luminal A or Luminal B) metastatic breast cancer who were managed and treated with CDK4/6 inhibitors at Sohag University Hospital and SCI . Data will be extracted from their existing medical records.
Key inclusion criteria (2 listed)
- patients who are more than 18 years old at time of diagnosis and less than 80 years
- metastatic breast cancer luminal A and luminal B of either sex
Key exclusion criteria (3 listed)
- patients diagnosed with double malignancy
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 inhibitorsRetrospective evaluation of patients who received standard clinical doses of CDK4/6 inhibitors as part of their treatment regimen for metastatic luminal A and luminal B breast cancer. | Drug | luminal A subgroup, luminal B subgroup |
Primary outcome
progression free survival
Time frame: Up to 4 years أو From initiation of CDK4/6 inhibitor therapy to disease progression or death, up to 4 years.
Progression-free survival is defined as the time from initiation of CDK4/6 inhibitor therapy until documented disease progression or death from any cause.
Progression-Free Survival (PFS)
Time frame: From the date of therapy initiation up to 4 yrs
PFS is defined as the time from the initiation of CDK4/6 inhibitor therapy to the date of documented disease progression or death from any cause, whichever occurs first.
Progression-Free Survival (PFS)
Time frame: From the date of therapy initiation up to 4 years (the period of retrospective medical records review).
PFS is defined as the time from the initiation of CDK4/6 inhibitor therapy to the date of documented disease progression or death from any cause, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No. regulations and hospital policies
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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 Metastatic Breast Cancer, run by Sohag 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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
progression free survival (time frame: Up to 4 years أو From initiation of CDK4/6 inhibitor therapy to disease progression or death, up to 4 years.). The study lists 3 primary outcomes in all. 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 15 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.