Hormone-receptor-positive Breast CancerPalbociclibNCT06338644
Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.
An observational study of Hormone-receptor-positive Breast Cancer and Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, run by Helwan University.
Trial summary
Cyclin-dependent kinase (CDK) 4/6 inhibitors are a class of agents recently introduced in the clinic for the treatment of advanced hormone receptor-positive (HR+) and HER2-negative (HER2-) BC. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Metastatic Breast Cancer
- What is being tested?
- Palbociclib
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Sep 2026
- 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: Hormone receptor-positive HER2-negative metastatic breast cancer patients
Who may be able to join
- 1. Adult patients (≥18 years). 2. Confirmed diagnosis with MBC. 3. HR-positive/HER2-negative MBC as ascertained by immunohistochemistry (IHC) or fluorescence in situ hybridization in primary or metastatic tissue samples.
- 4. Patients with primary or secondary resistance to endocrine therapy. 5. Patients with Eastern Cooperative Oncology Group (ECOG) 0 or 1. 6. Scheduled to receive Palbociclib in first- or second-line metastatic setting.
Who cannot join
- Prior exposure to fulvestrant or everolimus.
- Patients with uncontrolled brain metastases or symptomatic visceral spread who are at risk of life-threatening complications.
- Patients refusing to sign the written informed consent.
About this study
Cyclin-dependent kinase (CDK) 4/6 inhibitors are a class of agents recently introduced in the clinic for the treatment of advanced hormone receptor-positive (HR+) and HER2-negative (HER2-) BC. Palbociclib, ribociclib and abemaciclib have all been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency among other regulatory bodies
Read the detailed description
Several factors are thought to influence the variability of treatment efficacy and toxicity, including organ function, comedications, hormonal status, body weight, age, comorbidities, etc. Among them, single nucleotide polymorphisms (SNPs) as rs1128503, rs2032583 are attracting huge interest to address the interindividual variability in drug response, whether in terms of efficacy or safety
- Conditions
- Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Metastatic Breast Cancer
- Being tested
- Palbociclib
- Keywords
- Metastatic breast Cancer, Palbociclib, Pharmacogenomic
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
3 weeks on, 1 week off
| Study group | Role | What they receive |
|---|---|---|
| Primary resistant to endocrine therapy | Primary endocrine resistance is defined as a relapse within 2 years of adjuvant endocrine treatment or disease progression during the first 6 months of first-line endocrine therapy for advanced or MBC Receives: Drug: Palbociclib | |
| Secondary resistant to endocrine therapy | Secondary resistance is defined in early BC as a relapse that occurs after at least 2 years of endocrine therapy and during or within the first year of completing adjuvant endocrine therapy. In advanced BC or MBC, secondary resistance is defined as disease progression after more than 6 months of endocrine therapy Receives: Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Progression free survival (PFS)
the time from enrollment until first evidence of disease progression or death
Measured: 1 year
Secondary outcomes (1)
Neutropenia
Grade 3 or 4 neutropenia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hormone-receptor-positive Breast CancerStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yassmin Genina, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338644
- Sponsor's protocol ID
- HelwanUY
- Acronym
- Palbociclib
- Status last verified
- Mar 2024
- First submitted
- 24 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mohamed Ebid AI, Fahim Genina YM, Shawky Haffez HR, Ahmed Hakam SH, Hassan Kassem LM, Mohamed AbdelMotaleb SM. Palbociclib in endocrine-resistant metastatic breast cancer: real-world outcomes. Expert Rev Anticancer Ther. 2026 Feb;26(2):263-272. doi: 10.1080/14737140.2025.2560941. Epub 2025 Sep 21.
PubMed 40957562
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.
- ClinicalTrials.gov ID
- NCT06338644
- Acronym / sponsor ID
- Palbociclib / HelwanUY
- Conditions
- Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Metastatic Breast Cancer
- Keywords
- Metastatic breast Cancer, Palbociclib, Pharmacogenomic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 29 Mar 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.
Cyclin-dependent kinase (CDK) 4/6 inhibitors are a class of agents recently introduced in the clinic for the treatment of advanced hormone receptor-positive (HR+) and HER2-negative (HER2-) BC. Palbociclib, ribociclib and abemaciclib have all been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency among other regulatory bodies
Detailed description
Several factors are thought to influence the variability of treatment efficacy and toxicity, including organ function, comedications, hormonal status, body weight, age, comorbidities, etc. Among them, single nucleotide polymorphisms (SNPs) as rs1128503, rs2032583 are attracting huge interest to address the interindividual variability in drug response, whether in terms of efficacy or safety
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary resistant to endocrine therapy | – | Drug: PalbociclibPrimary endocrine resistance is defined as a relapse within 2 years of adjuvant endocrine treatment or disease progression during the first 6 months of first-line endocrine therapy for advanced or MBC |
| Secondary resistant to endocrine therapy | – | Drug: PalbociclibSecondary resistance is defined in early BC as a relapse that occurs after at least 2 years of endocrine therapy and during or within the first year of completing adjuvant endocrine therapy. In advanced BC or MBC, secondary resistance is defined as disease progression after more than 6 months of endocrine therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hormone receptor-positive HER2-negative metastatic breast cancer patients
Key inclusion criteria (2 listed)
- 1. Adult patients (≥18 years). 2. Confirmed diagnosis with MBC. 3. HR-positive/HER2-negative MBC as ascertained by immunohistochemistry (IHC) or fluorescence in situ hybridization in primary or metastatic tissue samples.
- 4. Patients with primary or secondary resistance to endocrine therapy. 5. Patients with Eastern Cooperative Oncology Group (ECOG) 0 or 1. 6. Scheduled to receive Palbociclib in first- or second-line metastatic setting.
Key exclusion criteria (3 listed)
- Prior exposure to fulvestrant or everolimus.
- Patients with uncontrolled brain metastases or symptomatic visceral spread who are at risk of life-threatening complications.
- Patients refusing to sign the written informed consent.
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 |
|---|---|---|
| Palbociclib3 weeks on, 1 week off | Drug | Primary resistant to endocrine therapy, Secondary resistant to endocrine therapy |
Primary outcome
1-year Progression free survival (PFS)
Time frame: 1 year
the time from enrollment until first evidence of disease progression or death
1 secondary outcome
Neutropenia
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Derived from this study: PubMed 40957562Mohamed Ebid AI, Fahim Genina YM, Shawky Haffez HR, Ahmed Hakam SH, Hassan Kassem LM, Mohamed AbdelMotaleb SM. Palbociclib in endocrine-resistant metastatic breast cancer: real-world outcomes. Expert Rev Anticancer Ther. 2026 Feb;26(2):263-272. doi: 10.1080/14737140.2025.2560941. Epub 2025 Sep 21.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hormone-receptor-positive Breast Cancer and Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, run by Helwan University.
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: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
1-year Progression free survival (PFS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06338644, which also lists 1 linked publication.
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 29 Mar 2024.