Real-World Clinical Outcomes and Toxicity in Metastatic Breast Cancer Patients Treated With First or Second Line CDK 4/6 Inhibitors and Endocrine Therapy

NCT06558084 | Completed FDA Drug

• 1 other identifier: CDKTOX2024
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

To assess CDK4/6i toxicity and effect on PFS in the Egyptian population

Conditions

Toxicity, Drug; Progression, Disease

Keywords

Breast cancer; CDK4/6 inhibitor; toxicity; PFS

Outcome Measures

Primary Outcomes (1)

• Adverse effect

  assess the toxicity profile

  2 years

Secondary Outcomes (1)

• PFS

  2 years

Study Arms (1)

Metastatic breast cancer patients

metastatic breast cancer patient receiving CDK4/6i in 1st or 2nd line

Drug: CDK4/6 Inhibitor

Interventions

CDK4/6 Inhibitor DRUG

CDK4/6 inhibitor in first and second lines

Metastatic breast cancer patients

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast Cancer patients attending Ain Shams University Clinical Oncology and Nuclear Medicine Department breast clinic from July 2022 till December 2024

You may qualify if:

• Breast cancer patients aged 18 years old or more
• Female patients
• Histologically proven invasive breast cancer
• Histologically proven HR-positive and HER2-negative breast cancer
• Metastatic breast cancer (Stage 4 according to AJCC 8th edition 2017)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 3.
• Adequate hematological and organs function
• Patients receiving CDK 4/6 inhibitor combined with endocrine therapy(Aromatase inhibitors , GnRH agonists, fulvastrent). as a first or second line treatment

You may not qualify if:

• \- Male breast cancer patients
• Patients in, visceral crisis (defined as : severe organ dysfunction, as assessed by signs and symptoms, laboratory studies and rapid progression of disease ) that are at risk of life threatening complication in the short term.
• Prior treatment with any CDK 4/6 inhibitor.
• History of any other cancer , unless in complete remission with no therapy for a minimum of 3 years.
• Have active bacterial or fungal infection, or detectable viral infection.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Disease Progression; Breast Neoplasms

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: July 6, 2022
• Primary Completion: July 31, 2024
• Study Completion: August 10, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

EG (1)