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Clinical Outcome and Toxicity Data in Patients With Advanced Breast Cancer Treated With CDK Inhibitors Combined With Endocrine Therapy (HeCOG/CDKi)

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ClinicalTrials.gov Identifier: NCT04133207
Recruitment Status : Active, not recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Hellenic Cooperative Oncology Group

Brief Summary:
The present study will assess real-world clinical outcomes and adverse events from treatment with endocrine therapy combined with CDKi in patients with HR-positive, HER2-negative advanced breast cancer.

Condition or disease
Breast Cancer Stage IV

Detailed Description:

Patients This will be a retrospective analysis of patients with histologically confirmed HR-positive, HER2-negative advanced (recurrent or metastatic) breast cancer. The investigators will use data from patients treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology. Eligible patients will be of 18 years or older, women of any menopausal status with HR-positive/HER2-negative advanced breast cancer who have received treatment with CDKi in combination with endocrine therapy for their advanced breast cancer. Treatment combinations of CDKi with any endocrine therapy will be accepted. Patients will be included in the analysis if they heve received at least two months of treatment with a CDKi. Patient clinical data will be obtained from their medical records. Toxicity data will be recorded from the clinicians' documentations during scheduled patient clinical visits.

Statistical analysis The primary endpoint of the study will be progression-free survival (PFS), defined as the time from treatment initiation to either the first documented disease progression or death from any cause. Secondary endpoint will be overall survival (OS), defined as the time from treatment initiation to patient death or last contact. Patients alive will be censored at the date of last contact. Adverse events will be graded based on Common Terminology Criteria for Adverse Events (CTCAE, version 4.0). Survival curves will be estimated using the Kaplan-Meier method and compared across groups with the log-rank test. The associations between the clinicopathological factors to be examined and the mortality rate will be evaluated with hazard ratios estimated with Cox proportional hazards model. The statistical analyses will be completed using the SAS software (SAS for Windows, version 9.3, SAS Institute Inc., Cary, NC).


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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Registry Study of Patients With Advanced Breast Cancer Treated With Cyclin-dependent Kinase 4/6 (CDK4/6) Inhibitors Combined With Endocrine Therapy: the Experience of the Hellenic Cooperative Oncology Group
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : August 1, 2019
Estimated Study Completion Date : January 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
Patients with advanced HR-positive breast cancer
patients with histologically confirmed HR-positive, HER2-negative advanced (recurrent or metastatic) breast cancer. Patients had been treated in Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology



Primary Outcome Measures :
  1. Toxicity rates [ Time Frame: Time Frame: through the completion of the study, up to 2 years ]
    Rates of adverse events from the combination of CDKi and endocrine therapy


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Time Frame: from the date of treatment start until death from any cause or date of last contact whichever occurred first, assessed up to 60 months ]
    Overall survival was defined as the time from diagnosis until death from any cause or last follow-up


Biospecimen Retention:   None Retained
Blood samples will be collected from patients with pancreatic cancer


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This was a retrospective analysis of patients with histologically confirmed HR-positive, HER2-negative advanced (recurrent or metastatic) breast cancer. Patients had been treated in Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology.
Criteria

Inclusion Criteria:

  • 18 years or older
  • Αny menopausal status is allowed
  • HR-positive/HER2-negative advanced breast cancer
  • Patients treated with CDKi in combination with endocrine therapy for their advanced breast cancer
  • Combinations of CDKi with any endocrine therapy are allowed
  • More than two months of treatment with a CDKi is mandatory

Exclusion criteria:

• Treatment with CDKi as (neo)adjuvant treatment


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133207


Locations
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Greece
Hellenic Oncology Cooperative Group
Athens, Greece
Sponsors and Collaborators
Hellenic Cooperative Oncology Group

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Responsible Party: Hellenic Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT04133207     History of Changes
Other Study ID Numbers: CDK-HeCOG-2019
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hellenic Cooperative Oncology Group:
CDK
Breast cancer
toxicity
outcome
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases