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

NCT06076772 | Not Yet Recruiting

• 1 other identifier: Palbociclib
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  2 years

• assess treatment outcome as a progression free survival for palbociclib in patient with neutropenia

  Measure the progression free survival

  2 years

• assess treatment outcome as overall survival for palbociclib in patient with neutropenia

  Measure the overall survival

  2 years

Study Arms (2)

1

cases developed neutropenia Grade 0-2 with palbociclib administration

Drug: Palbociclib

2

cases developed neutropenia Grade 3-4 with palbociclib administration

Drug: Palbociclib

Interventions

Palbociclib DRUG

The investigator will follow the patients after starting treatment to follow and observe the outcome of the treatment side effects and risk factors

Also known as: Other drugs (hormonal treatment)+ denosumab

1; 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Patient with co-morbidity
• Pregnant and breast lactating women

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Asmaa Imam Ahmed

Al Madīnah, AL, 11564, Saudi Arabia

Location

Related Publications (6)

• 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.

  PMID: 37054718 BACKGROUND

• McAndrew 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.

  PMID: 32641862 BACKGROUND

• Lavery 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.

  PMID: 36260177 BACKGROUND

• Kanbayashi 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.

  PMID: 34625634 BACKGROUND

• Lee 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.

  PMID: 37345147 BACKGROUND

• Vazquez 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.

  PMID: 33820647 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Asmaa I Ahmed, Master

CONTACT

01065751145; Asmaa.mekkawy@yahoo.com

Hanan G Mostafa, MD

CONTACT

01004082002; Mostafahanan36@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 11, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

SA (1)