Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients

October 8, 2023 updated by: Asmaa I Mekkawy, Assiut University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Saudi Arabia
    • AL
      • Al Madīnah, AL, Saudi Arabia, 11564
        • Asmaa Imam Ahmed
        • Contact:
          • Asmaa I Ahmed
          • Phone Number: 0562059896

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patient receiving Palbociclib in combination with hormonal treatment as first-line therapy in metastatic hormone receptor- positive HER2 negative breast cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
cases developed neutropenia Grade 0-2 with palbociclib administration
Drug: Palbociclib
The investigator will follow the patients after starting treatment to follow and observe the outcome of the treatment side effects and risk factors
Other Names:
  • Other drugs (hormonal treatment)+ denosumab
2
cases developed neutropenia Grade 3-4 with palbociclib administration
Drug: Palbociclib
The investigator will follow the patients after starting treatment to follow and observe the outcome of the treatment side effects and risk factors
Other Names:
  • Other drugs (hormonal treatment)+ denosumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years
assess treatment outcome as a progression free survival for palbociclib in patient with neutropenia
Time Frame: 2 years
Measure the progression free survival
2 years
assess treatment outcome as overall survival for palbociclib in patient with neutropenia
Time Frame: 2 years
Measure the overall survival
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

October 8, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 8, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Palbociclib

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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