Status:
COMPLETED
CARE Initiative: Real-world Emulation of the PALOMA-2 Trial
Lead Sponsor:
Aetion, Inc.
Collaborating Sponsors:
AbbVie
Amgen
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
The goal of this non-interventional study is to emulate the PALOMA-2 randomized controlled trial of palbociclib as first-line therapy in patients with estrogen receptor-positive (ER+)/human epidermal ...
Detailed Description
The Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation (CARE) Initiative is a program designed to build an empirical evidence base for the use of real-world data (R...
Eligibility Criteria
Inclusion
- Breast cancer diagnosis
- Histology not indicative of non-adenocarcinoma histologies
- Metastatic disease
- Estrogen-receptor positive (ER+)
- No prior systemic treatment for metastatic breast cancer
- Post-menopausal
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 or missing or Karnofsky performance status \>=50 or missing
- No lab results indicating inadequate organ function, as defined in the PALOMA-2 RCT protocol
Exclusion
- Human epidermal growth factor receptor 2 (HER2) positive tumor
- Diagnosis of brain, central nervous system, and/or spinal cord metastases
- Neoadjuvant or adjuvant treatment with anastrozole or letrozole ≤12 months before metastatic diagnosis
- Prior treatment with treatment with ribociclib, abemaciclib, or palbociclib
- Treatment with a CYP3A4 inhibitor or inducer or drugs known to prolong the QT interval, as specified in the PALOMA-2 trial protocol, in the 7 days prior to study treatment initiation
- Anti-cancer therapy or major cancer-related surgery within 2 weeks before study treatment initiation
- Diagnosis of a second primary malignancy within 3 years prior to study treatment initiation
- Diagnosis of long or short QT syndrome, Brugada syndrome, QTc prolongation, or Torsade de Pointes
- Diagnosis of hypocalcemia, hypokalemia, or hypomagnesemia
- Diagnosis of myocardial infarction, angina, ongoing cardiac dysrhythmias, atrial fibrillation, congestive heart failure, cerebral infarction, transient ischemic attack, or pulmonary embolism in the 6 months prior to study treatment initiation
- Diagnosis of inflammatory bowel disease chronic diarrhea, or short bowel syndrome
- Diagnosis of human immunodeficiency virus infection
Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 20 2023
Estimated Enrollment :
724 Patients enrolled
Trial Details
Trial ID
NCT06607601
Start Date
February 1 2010
End Date
July 20 2023
Last Update
September 23 2024
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