Metastatic Breast CancerNCT06076772
Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients
An observational study of Metastatic Breast Cancer, run by Assiut University at 1 site in Saudi Arabia.
Trial summary
Aim of the study to assess the neutropenia induced by Palbociclib in patient receiving Palbociclib in combination with hormonal treatment as first-line therapy in metastatic hormone receptor- positive HER2 negative breast cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Palbociclib
- How many people
- 54 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Nov 2023to Dec 2026
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patient receiving Palbociclib in combination with hormonal treatment as first-line therapy in metastatic hormone receptor- positive HER2 negative breast cancer
Who may be able to join
- Histological pathological confirmation of primary breast cancer or metastatic disease.
- Hormonal receptor-positive, HER2 negative.
- Metastatic breast cancer at presentation (Den novo) or recurrent.
- Patients did not receive any previous systemic therapy for metastatic disease.
- Performance status (ECOG) 0-2.
Who cannot join
- Patient with co-morbidity
- Pregnant and breast lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Asmaa Imam Ahmed
Al Madīnah, AL, 11564
Asmaa I Ahmed, 0562059896
About this study
Aim of the study to assess the neutropenia induced by Palbociclib in patient receiving Palbociclib in combination with hormonal treatment as first-line therapy in metastatic hormone receptor- positive HER2 negative breast cancer. To evaluate the risk factors for occurrence of neutropenia and treatment outcome as 2 years PFS and OS.
Read the detailed description
Palbociclib is an orally active cyclin-dependent kinase (CDK) and is considered the standard treatment for hormone receptor (HR)-positive, (HER) negative metastatic breast cancer.
The PALOMA studies' showed improvement in progression-free survival (PFS) compared to endocrine therapy alone but a non-significant trend towards improved overall survival (OS).
MONALEESA and MONARCH suggest significantly improved OS with the addition of CDK inhibition.
Neutropenia is considered the dose-limiting and most frequent adverse effect of CDK inhibitors resulting in frequent dose reductions and treatment interruptions that are potentially associated with a lack of efficiency. Grade III/IV neutropenia rates were 62-66% in the PALOMA studies.
Some studies investigated the risk factors for the development of palbociclib-induced neutropenia. One concluded that no concomitant use of statins and high BMI were identified as significant predictors for the development of palbociclib-induced neutropenia. and another study also concluded that low baseline ANC, WBC, PLT, and BSA were associated with early grade III/IV neutropenia.
Regarding treatment outcome, two Phase Two clinical trials concluded that the treatment-related neutropenia in the first two cycles was significantly and independently associated with prolonged PFS, suggesting that neutropenia may be a useful pharmacodynamic marker to guide individualised palbociclib dosing.
However, another study concluded that limited dose modification may lead to longer PFS, without increasing toxicity, than the conventional dose scheme.
A study of variable risk factors and treatment outcomes for palbociclib-induced neutropenia will be useful for careful monitoring leading to adapted therapy.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Palbociclib
- 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
Also called Other drugs (hormonal treatment)+ denosumab
The investigator will follow the patients after starting treatment to follow and observe the outcome of the treatment side effects and risk factors
| Study group | Role | What they receive |
|---|---|---|
| 1 | cases developed neutropenia Grade 0-2 with palbociclib administration Receives: Drug: Palbociclib | |
| 2 | cases developed neutropenia Grade 3-4 with palbociclib administration Receives: Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator will evaluate the patients and treatment characters in counts and percentage of developing high-grade neutropenia induced by palbociclib.
Investigator will record the patients and treatment characters in counts and percentage that associated with the occurrence of high-grade neutropenia. And then will compare the characters differences in patients with and without high grade neutropenia by uninitiated and multivariate statistical analysis.
Measured: 2 years
assess treatment outcome as a progression free survival for palbociclib in patient with neutropenia
Measure the progression free survival
Measured: 2 years
assess treatment outcome as overall survival for palbociclib in patient with neutropenia
Measure the overall survival
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 posted11 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 54 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa I Mekkawy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076772
- Sponsor's protocol ID
- Palbociclib
- Status last verified
- Oct 2023
- First submitted
- 18 Sep 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim SG, Kim MH, Park S, Kim GM, Kim JH, Kim JY, Park HS, Park S, Park BW, Kim SI, Ji JH, Jeong J, Shin K, Lee J, Kim HD, Jung KH, Sohn J. Efficacy of Limited Dose Modifications for Palbociclib-Related Grade 3 Neutropenia in Hormone Receptor-Positive Metastatic Breast Cancer. Cancer Res Treat. 2023 Oct;55(4):1198-1209. doi: 10.4143/crt.2022.1543. Epub 2023 Apr 11.
PubMed 37054718McAndrew NP, Dickson MA, Clark AS, Troxel AB, O'Hara MH, Colameco C, Gallager M, Gramlich K, Zafman K, Vaughn D, Schwartz GK, O'Dwyer PJ, DeMichele A. Early treatment-related neutropenia predicts response to palbociclib. Br J Cancer. 2020 Sep;123(6):912-918. doi: 10.1038/s41416-020-0967-7. Epub 2020 Jul 9.
PubMed 32641862Lavery L, DiSogra K, Lea J, Trufan SJ, Symanowski JT, Roberts A, Moore DC, Heeke A, Pal S. Risk factors associated with palbociclib-induced neutropenia in patients with metastatic breast cancer. Support Care Cancer. 2022 Dec;30(12):9803-9809. doi: 10.1007/s00520-022-07400-z. Epub 2022 Oct 19.
PubMed 36260177Kanbayashi Y, Sakaguchi K, Ishikawa T, Takayama K, Taguchi T. Predictors for development of palbociclib-induced neutropenia in breast cancer patients as determined by ordered logistic regression analysis. Sci Rep. 2021 Oct 8;11(1):20055. doi: 10.1038/s41598-021-99504-5.
PubMed 34625634Lee Y, Lee D, Seo I, Chae H, Sim SH, Lee KS, Gwak HS. Risk Factors for Palbociclib-Induced Early Developing Neutropenia in Patients with Hormone Receptor-Positive Metastatic Breast Cancer. Cancers (Basel). 2023 May 18;15(10):2810. doi: 10.3390/cancers15102810.
PubMed 37345147Vazquez L, Arnaud A, Grenier J, Debourdeau P. [Patients treated with palbociclib and endocrine therapy for metastatic breast cancer: Can we predict the occurrence of severe early hematological toxicity?]. Bull Cancer. 2021 May;108(5):544-552. doi: 10.1016/j.bulcan.2021.01.007. Epub 2021 Apr 2. French.
PubMed 33820647
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06076772
- Acronym / sponsor ID
- Palbociclib
- Conditions
- Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Oct 2023 (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.
Aim of the study to assess the neutropenia induced by Palbociclib in patient receiving Palbociclib in combination with hormonal treatment as first-line therapy in metastatic hormone receptor- positive HER2 negative breast cancer. To evaluate the risk factors for occurrence of neutropenia and treatment outcome as 2 years PFS and OS.
Detailed description
Palbociclib is an orally active cyclin-dependent kinase (CDK) and is considered the standard treatment for hormone receptor (HR)-positive, (HER) negative metastatic breast cancer.
The PALOMA studies' showed improvement in progression-free survival (PFS) compared to endocrine therapy alone but a non-significant trend towards improved overall survival (OS).
MONALEESA and MONARCH suggest significantly improved OS with the addition of CDK inhibition.
Neutropenia is considered the dose-limiting and most frequent adverse effect of CDK inhibitors resulting in frequent dose reductions and treatment interruptions that are potentially associated with a lack of efficiency. Grade III/IV neutropenia rates were 62-66% in the PALOMA studies.
Some studies investigated the risk factors for the development of palbociclib-induced neutropenia. One concluded that no concomitant use of statins and high BMI were identified as significant predictors for the development of palbociclib-induced neutropenia. and another study also concluded that low baseline ANC, WBC, PLT, and BSA were associated with early grade III/IV neutropenia.
Regarding treatment outcome, two Phase Two clinical trials concluded that the treatment-related neutropenia in the first two cycles was significantly and independently associated with prolonged PFS, suggesting that neutropenia may be a useful pharmacodynamic marker to guide individualised palbociclib dosing.
However, another study concluded that limited dose modification may lead to longer PFS, without increasing toxicity, than the conventional dose scheme.
A study of variable risk factors and treatment outcomes for palbociclib-induced neutropenia will be useful for careful monitoring leading to adapted therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Palbociclibcases developed neutropenia Grade 0-2 with palbociclib administration |
| 2 | – | Drug: Palbociclibcases developed neutropenia Grade 3-4 with palbociclib administration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patient receiving Palbociclib in combination with hormonal treatment as first-line therapy in metastatic hormone receptor- positive HER2 negative breast cancer
Key inclusion criteria (5 listed)
- Histological pathological confirmation of primary breast cancer or metastatic disease.
- Hormonal receptor-positive, HER2 negative.
- Metastatic breast cancer at presentation (Den novo) or recurrent.
- Patients did not receive any previous systemic therapy for metastatic disease.
- Performance status (ECOG) 0-2.
Key exclusion criteria (2 listed)
- Patient with co-morbidity
- Pregnant and breast lactating women
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 |
|---|---|---|
| PalbociclibAlso: Other drugs (hormonal treatment)+ denosumabThe investigator will follow the patients after starting treatment to follow and observe the outcome of the treatment side effects and risk factors | Drug | 1, 2 |
Primary outcome
Investigator will evaluate the patients and treatment characters in counts and percentage of developing high-grade neutropenia induced by palbociclib.
Time frame: 2 years
Investigator will record the patients and treatment characters in counts and percentage that associated with the occurrence of high-grade neutropenia. And then will compare the characters differences in patients with and without high grade neutropenia by uninitiated and multivariate statistical analysis.
assess treatment outcome as a progression free survival for palbociclib in patient with neutropenia
Time frame: 2 years
Measure the progression free survival
assess treatment outcome as overall survival for palbociclib in patient with neutropenia
Time frame: 2 years
Measure the overall survival
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 11 Oct 2023.
- Background: PubMed 37054718Kim SG, Kim MH, Park S, Kim GM, Kim JH, Kim JY, Park HS, Park S, Park BW, Kim SI, Ji JH, Jeong J, Shin K, Lee J, Kim HD, Jung KH, Sohn J. Efficacy of Limited Dose Modifications for Palbociclib-Related Grade 3 Neutropenia in Hormone Receptor-Positive Metastatic Breast Cancer. Cancer Res Treat. 2023 Oct;55(4):1198-1209. doi: 10.4143/crt.2022.1543. Epub 2023 Apr 11.
- Background: PubMed 32641862McAndrew NP, Dickson MA, Clark AS, Troxel AB, O'Hara MH, Colameco C, Gallager M, Gramlich K, Zafman K, Vaughn D, Schwartz GK, O'Dwyer PJ, DeMichele A. Early treatment-related neutropenia predicts response to palbociclib. Br J Cancer. 2020 Sep;123(6):912-918. doi: 10.1038/s41416-020-0967-7. Epub 2020 Jul 9.
- Background: PubMed 36260177Lavery L, DiSogra K, Lea J, Trufan SJ, Symanowski JT, Roberts A, Moore DC, Heeke A, Pal S. Risk factors associated with palbociclib-induced neutropenia in patients with metastatic breast cancer. Support Care Cancer. 2022 Dec;30(12):9803-9809. doi: 10.1007/s00520-022-07400-z. Epub 2022 Oct 19.
- Background: PubMed 34625634Kanbayashi Y, Sakaguchi K, Ishikawa T, Takayama K, Taguchi T. Predictors for development of palbociclib-induced neutropenia in breast cancer patients as determined by ordered logistic regression analysis. Sci Rep. 2021 Oct 8;11(1):20055. doi: 10.1038/s41598-021-99504-5.
- Background: PubMed 37345147Lee Y, Lee D, Seo I, Chae H, Sim SH, Lee KS, Gwak HS. Risk Factors for Palbociclib-Induced Early Developing Neutropenia in Patients with Hormone Receptor-Positive Metastatic Breast Cancer. Cancers (Basel). 2023 May 18;15(10):2810. doi: 10.3390/cancers15102810.
- Background: PubMed 33820647Vazquez L, Arnaud A, Grenier J, Debourdeau P. [Patients treated with palbociclib and endocrine therapy for metastatic breast cancer: Can we predict the occurrence of severe early hematological toxicity?]. Bull Cancer. 2021 May;108(5):544-552. doi: 10.1016/j.bulcan.2021.01.007. Epub 2021 Apr 2. French.
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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.
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 Assiut University at 1 site in Saudi Arabia.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 11 Oct 2023. 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 Saudi Arabia. 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?
Contact Asmaa I Ahmed, Master (01065751145, Asmaa.mekkawy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator will evaluate the patients and treatment characters in counts and percentage of developing high-grade neutropenia induced by palbociclib. (time frame: 2 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?
On the ClinicalTrials.gov record for NCT06076772, which also lists 6 linked publications.
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 11 Oct 2023.