Metastatic Breast Cancer
Conditions
Brief 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.
Interventions
DRUGPalbociclib
The investigator will follow the patients after starting treatment to follow and observe the outcome of the treatment side effects and risk factors
Sponsors
Assiut University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator will evaluate the patients and treatment characters in counts and percentage of developing high-grade neutropenia induced by palbociclib. | 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 | 2 years | Measure the progression free survival |
| assess treatment outcome as overall survival for palbociclib in patient with neutropenia | 2 years | Measure the overall survival |
Countries
Saudi Arabia
Contacts
Primary ContactAsmaa I Ahmed, Master
Backup ContactHanan G Mostafa, MD
Outcome results
None listed