Phase 3
Completed N=340
A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]
Source: ClinicalTrials.gov NCT02297438 ↗Enrolled (actual)
340
Serious AEs
15.6%
Results posted
Nov 2021
Primary outcomePrimary: Progression-Free Survival (PFS) Based on Investigator's Assessment: Up to Primary Completion Date — 21.5; 13.9 Months — p=0.0012
◆ Published Evidence
Established
74citations · ~19 / year
Palbociclib plus letrozole versus placebo plus letrozole in Asian postmenopausal women with oestrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: Primary results from PALOMA-4.
Summary
The study is designed to compare the clinical benefit following treatment with letrozole in combination with Palbociclib versus letrozole in combination with placebo in Asian postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.
Linked Publications (2)
-
Palbociclib plus letrozole versus placebo plus letrozole in Asian postmenopausal women with oestrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: Primary results from PALOMA-4.
-
Patient-reported quality of life in Asian patients with ER+/HER2- advanced breast cancer treated with palbociclib plus letrozole in the PALOMA-4 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) Based on Investigator's Assessment: Up to Primary Completion Date |
21.5; 13.9 | 0.0012 sig |
| SECONDARY Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR): Up to Primary Completion Date |
21.6; 16.4 | 0.14778 |
| SECONDARY Percentage of Participants With Objective Response (OR) Based on Investigator Assessment: Up to Primary Completion Date |
37.3; 31.6 | 0.154 |
| SECONDARY Percentage of Participants With Objective Response (OR) Based on Investigator Assessment (Participants With Measurable Disease at Baseline): Up to Primary Completion Date |
43.4; 38.0 | 0.206 |
| SECONDARY Percentage of Participants With Objective Response (OR) Based on Blinded Independent Central Review (BICR): Up to Primary Completion Date |
40.2; 33.9 | 0.135 |
| SECONDARY Percentage of Participants With Objective Response (OR) Based on Blinded Independent Central Review (BICR) (Participants With Measurable Disease at Baseline): Up to Primary Completion Date |
52.3; 43.5 | 0.117 |
| SECONDARY Duration of Response (DOR) Based on Investigator Assessment (Participants With Objective Disease Response): Up to Primary Completion Date |
22.4; 19.4 | — |
| SECONDARY Duration of Response (DOR) Based on Blinded Independent Central Review (BICR) (Participants With Objective Disease Response): Up to Primary Completion Date |
30.3; 24.9 | — |
| SECONDARY Percentage of Participants With Disease Control/Clinical Benefit Response (DC/CBR) Based on Investigator Assessment: Up to Primary Completion Date |
79.3; 80.1 | 0.471 |
| SECONDARY Percentage of Participants With Disease Control/Clinical Benefit Response (DC/CBR) Based on Investigator Assessment (Participants With Measurable Disease at Baseline): Up to Primary Completion Date |
77.9; 79.6 | 0.383 |
| SECONDARY Percentage of Participants With Disease Control/Clinical Benefit Response (DC/CBR) Based on Blinded Independent Central Review (BICR): Up to Primary Completion Date |
76.9; 73.1 | 0.248 |
| SECONDARY Percentage of Participants With Disease Control/Clinical Benefit Response (DC/CBR) Based on Blinded Independent Central Review (BICR) (Participants With Measurable Disease at Baseline): Up to Primary Completion Date |
78.1; 71.8 | 0.189 |
| SECONDARY Overall Survival (OS): Up to Primary Completion Date |
51.7; 51.5 | 0.36502 |
| SECONDARY 1-Year, 2-Year and 3-Year Survival Probability: Up to Primary Completion Date |
92.8; 90.5; 80.3; 78.0; 67.1; 60.6 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (All Causalities): Up to Primary Completion Date |
168; 155; 26; 16; 152; 38 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (Treatment Related): Up to Primary Completion Date |
167; 123; 8; 3; 149; 18 | — |
| SECONDARY Number of Participants With Postbaseline Laboratory Abnormalities of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 (Participants With Baseline Laboratory Abnormalities of CTCAE Grade <=2) - Hematology: Up to Primary Completion Date |
143; 2; 77; 1; 13; 1 | — |
| SECONDARY Number of Participants With Postbaseline Laboratory Abnormalities of Common Terminology Criteria for Adverse Events(CTCAE) Grade 3 or 4 (Participants With Baseline Laboratory Abnormalities of CTCAE Grade <=2) - Chemistry: Up to Primary Completion Date |
9; 1; 0; 2; 9; 6 | — |
| SECONDARY Trough Plasma Concentration of Palbociclib |
81.1; 77.4; 80.2 | — |
| SECONDARY Model Estimated Mean Changes From Baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) Total Score: Up to Primary Completion Date |
1.618; 1.021; 1.441; 0.850; 1.087; 0.510 | 0.7862 |
| SECONDARY Model Estimated Mean Change From Baseline in Euro Quality of Life 5-Dimension Scale (EQ-5D) Index Scores: Up to Primary Completion Date |
0.013; 0.014; 0.012; 0.011; 0.010; 0.005 | 0.1914 |
| SECONDARY Model Estimated Mean Change From Baseline in Euro Quality of Life (EQ) Visual Analog Scale (VAS) Scores: Up to Primary Completion Date |
3.047; 1.861; 3.125; 1.815; 3.279; 1.724 | 0.0078 sig |
| SECONDARY Median Baseline Percent (%) Positive Cells for Ki67 |
30.0; 27.5 | — |
| SECONDARY Number of Participants With Detection in Estrogen Receptor (ER) |
152; 162; 2; 1; 14; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Adult Asian 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] 0-1
- 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 neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment
- Prior treatment with any CDK 4/6 inhibitor
Data sourced from ClinicalTrials.gov (NCT02297438) 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.