Phase 3
Completed N=666
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
Source: ClinicalTrials.gov NCT01740427 ↗Enrolled (actual)
666
Serious AEs
24.5%
Results posted
Apr 2017
Primary outcomePrimary: Progression-Free Survival (PFS) as Assessed by the Investigator — 24.8; 14.5 Months — p=<0.000001
◆ Published Evidence
Highly cited
174citations · ~87 / year
Overall Survival With Palbociclib Plus Letrozole in Advanced Breast Cancer.
Summary
The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.
Linked Publications (5)
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Overall Survival With Palbociclib Plus Letrozole in Advanced Breast Cancer.
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Clinical efficacy of CDK4/6 inhibitor plus endocrine therapy in HR-positive/HER2-0 and HER2-low-positive metastatic breast cancer: a secondary analysis of PALOMA-2 and PALOMA-3 trials.
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Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole <i>versus</i> palbociclib plus letrozole as first-line treatment of HR+/HER2- advanced breast cancer.
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Effect of palbociclib plus endocrine therapy on time to chemotherapy across subgroups of patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer: Post hoc analyses from PALOMA-2 and PALOMA-3.
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Effect of cross-platform gene-expression, computational methods on breast cancer subtyping in PALOMA-2 and PALLET studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) as Assessed by the Investigator |
24.8; 14.5 | <0.000001 sig |
| SECONDARY Objective Response as Assessed by the Investigator |
46.4; 38.3 | 0.0224 sig |
| SECONDARY Objective Response: Participants With Measurable Disease at Baseline as Assessed by the Investigator |
60.7; 49.1 | 0.0090 sig |
| SECONDARY Duration of Response (DR) |
20.1; 16.7 | — |
| SECONDARY Disease Control (DC)/Clinical Benefit Response (CBR) |
85.8; 71.2 | <0.0001 sig |
| SECONDARY PFS by Tumor Tissue Biomarkers Status, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6) |
24.9; 16.3; 15.6; 5.4; 24.2; 13.7 | <0.0001 sig |
| SECONDARY Corrected QT Interval (QTc) Time-Matched Change From Baseline on Cycle 1 Day 14 |
0.80; 2.95; 3.32; 1.65; 2.76; 1.74 | — |
| SECONDARY Percentage of Participants With Corrected QT Interval (QTc) |
80.5; 85.9; 17.9; 11.8; 1.1; 2.3 | — |
| SECONDARY Observed Plasma Trough Concentration (Ctrough) at Steady-State |
70.1; 64.2 | — |
| SECONDARY Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index |
0.014; -0.010 | 0.0925 |
| SECONDARY Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy-Breast (FACT-B) |
-0.106; 0.219 | 0.7822 |
| SECONDARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs): All Causalities |
99.1; 96.4; 28.2; 17.1; 83.1; 30.2 | — |
| SECONDARY Overall Survival (OS): Primary Analysis |
53.9; 51.2 | 0.337750 |
| SECONDARY Overall Survival (OS): Final Analysis |
53.8; 49.8 | 0.208706 |
| SECONDARY Survival Probability at 1 Year, 2 Year and 3 Year |
92.7; 94.9; 78.4; 82.5; 69.8; 65.0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade |
328; 90; 30; 6; 14; 25 | — |
Eligibility Criteria
Inclusion Criteria
- Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy.
- Confirmed diagnosis of ER positive breast cancer
- No prior systemic anti-cancer therapy for advanced ER+ disease.
- Postmenopausal women
- Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease
- Eastern Cooperative Oncology Group [ECOG] 0-2
- Adequate organ and marrow function
- Patient must agree to provide tumor tissue
Exclusion Criteria
- Confirmed diagnosis of HER2 positive disease
- Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
- Known uncontrolled or symptomatic CNS metastases
- Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from completion of treatment.
- Prior treatment with any CDK 4/6 inhibitor.
Data sourced from ClinicalTrials.gov (NCT01740427) and the linked publication. 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. Informational only — not medical advice.