A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer
NCT ID: NCT05584644
Last Updated: 2023-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
150 participants
OBSERVATIONAL
2021-05-24
2022-02-22
Brief Summary
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There are two groups of patients this study will describe. The first group of patients will have received palbociclib in combination with aromatase inhibitor (as prescribed by the Physician) for the treatment of postmenopausal women with HR+/HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease. The second group of patients will have received palbociclib for the treatment of hormone receptor HR+/HER2- advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Palbociclib plus hormonal treatment - first line treatment
Patients who initiated Palbociclib + hormonal therapy in the first line treatment
Palbociclib plus hormonal treatment - first line treatment
Palbociclib plus hormonal treatment
Palbociclib plus hormonal treatment - second line treatment
Patients who initiated palbociclib plus hormonal treatment in the second line treatment
Palbociclib plus hormonal treatment - second line treatment
Palbociclib plus hormonal treatment
Interventions
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Palbociclib plus hormonal treatment - first line treatment
Palbociclib plus hormonal treatment
Palbociclib plus hormonal treatment - second line treatment
Palbociclib plus hormonal treatment
Eligibility Criteria
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Inclusion Criteria
* Received palbociclib with aromatase inhibitor (as prescribed by the Physician) as initial endocrine therapy in postmenopausal metastatic breast cancer (MBC) patients or with fulvestrant in patients who have progressed on prior endocrine therapy
* Patients on Leutinizing Hormone Releasing Hormone (LHRH) agonists for ovarian function suppression in pre- or perimenopausal stage only if prescribed palbociclib with fulvestrant
* No prior or current enrolment in an interventional clinical trial for advanced/metastatic breast cancer
* Minimum of 3 months of follow up data since palbociclib with fulvestrant initiation, or minimum of 6 months of follow up data since palbociclib with aromatase inhibitor initiation
Exclusion Criteria
* Male breast cancer
* Visceral crisis
18 Years
99 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Hemato Oncology Clinic Ahmedabad Private Limited
Rajpath Club Lane ,Gujarat, India, Ahmedabad, India
Max Super Speciality Hospital
Patparganj, Delhi, India, India
HCG Cancer Centre
Ahmedabad, Gujarat, India, India
Indo-American Hospital
Nandi Nagar, Banjara Hills, Hyderabad, Telangana, India, India
Bhagwan Mahaveer Cancer Hospital and Research Centre
BajÄjnagar, Jaipur, Rajasthan, India, India
Max Super Speciality Hospital
Saket Institutional Area,, Saket, NEW Delhi, India, India
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A5481145
Identifier Type: -
Identifier Source: org_study_id