Phase 4
N=252
Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02679755 ↗Enrolled (actual)
252
Serious AEs
25.0%
Results posted
Oct 2020
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (All Causalities) — 92; 152; 244; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Palbociclib (Drug); Letrozole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Pfizer
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (All Causalities) |
92; 152; 244; 18; 45; 63 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events by Severity (All Causalities) |
7; 11; 18; 16; 16; 32 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (Palbociclib-Related) |
80; 143; 223; 8; 12; 20 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events by Severity (Palbociclib-Related) |
6; 21; 27; 10; 14; 24 | — |
| PRIMARY Number of Participants With Serious Adverse Events (All Causalities and Palbociclib-Related) |
18; 45; 63; 8; 12; 20 | — |
| SECONDARY Percentage of Participants With Complete Response and Partial Response |
1.0; 1.3; 1.2; 28.0; 11.8; 18.3 | — |
| SECONDARY The Objective Response Rate (ORR) |
29.0; 13.2; 19.4 | — |
| SECONDARY EQ-5D Health Utility Index Score |
0.786; 0.798; 0.798; 0.836; 0.838; 0.825 | — |
| SECONDARY Change From Baseline in EQ-5D Health Utility Index Score |
0.786; 0.013; 0.021; 0.052; 0.052; 0.037 | — |
| SECONDARY EQ-VAS Score |
76.9; 77.3; 77.4; 80.3; 80.4; 79.8 | — |
| SECONDARY Change From Baseline in EQ-VAS Score |
76.9; 0.4; 0.3; 2.9; 3.2; 2.3 | — |
Summary
A study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate.
Eligibility Criteria
Inclusion Criteria
- Post-menopausal women (>=18 years of age) with proven diagnosis of advanced carcinoma of the breast (ER(+) and/or PgR(+) and HER2(-)) who are appropriate for letrozole therapy (in the first-line advanced/metastatic disease setting).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate bone marrow, liver, and renal function.
Exclusion Criteria
- Prior treatment with any CDK inhibitor .
- QTc >480 msec; history of QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.
- High cardiovascular risk, including, but not limited to myocardial infarction, severe/unstable angina, severe cardiac dysrhythmias, and symptomatic pulmonary embolism in the past 6 months of enrollment.
Data sourced from ClinicalTrials.gov (NCT02679755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.