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Trial Title:
Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients
NCT ID:
NCT06076772
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Neutropenia
Denosumab
Palbociclib
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Palbociclib
Description:
The investigator will follow the patients after starting treatment to follow and observe
the outcome of the treatment side effects and risk factors
Arm group label:
1
Arm group label:
2
Other name:
Other drugs (hormonal treatment)+ denosumab
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. 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.
Criteria for eligibility:
Study pop:
patient receiving Palbociclib in combination with hormonal treatment as first-line
therapy in metastatic hormone receptor- positive HER2 negative breast cancer
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patient with co-morbidity
- Pregnant and breast lactating women
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Asmaa Imam Ahmed
Address:
City:
Al Madīnah
Zip:
11564
Country:
Saudi Arabia
Contact:
Last name:
Asmaa I Ahmed
Phone:
0562059896
Start date:
November 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06076772
