N/A
Completed N=191
UK Ibrance Patient Program (IPP) Study
HR+/HER2- Locally Advanced, Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT03921866 ↗
Enrolled (actual)
191
Serious AEs
28.3%
Results posted
Mar 2023
Primary outcomePrimary: Percentage of Participants According to Treatment Lines — 72; 16; 10; 2 Percentage of participants
Summary
What are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in United Kingdom patients with hormone receptor-positive, human epidermal growth factor 2-negative metastatic breast cancer treated as part of the IPP?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants According to Treatment Lines |
72; 16; 10; 2 | — |
| PRIMARY Time From Letrozole to Palbociclib Initiation |
430.8 | — |
| PRIMARY Number of Participants With Menopausal Status |
86; 94; 6; 1; 4; 35 | — |
| PRIMARY Percentage of Participants According to Disease Free Interval at Palbociclib Initiation |
29; 37; 34 | — |
| PRIMARY Percentage of Participants With Primary or Recurrent Metastatic Breast Cancer Diagnosis |
30; 70 | — |
| PRIMARY Percentage of Participants With Lymph Nodes Involvement |
58; 58; 58 | — |
| PRIMARY Number of Lymph Nodes Involved |
4.4; 4.4; 4.4 | — |
| PRIMARY Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status |
178; 2; 11; 1; 170; 20 | — |
| PRIMARY Percentage of Participants Who Had Rebiopsy After Metastatic Disease Diagnosis |
61 | — |
| PRIMARY Percentage of Participants According to Tumor Stage |
5; 19; 51; 21; 4; 12 | — |
| PRIMARY Percentage of Participants According to Nodal Status |
39; 38; 11; 12; 35; 30 | — |
| PRIMARY Percentage of Participants According to Metastasis |
64; 36; 100; 96; 4 | — |
| PRIMARY Tumor Size at Palbociclib Initiation |
35.4; 40.9; 33.1 | — |
| PRIMARY Percentage of Participants According to Tumor Grade |
10; 56; 34; 4; 63; 33 | — |
| PRIMARY Percentage of Participants With Ki-67 Protein Proliferation Index Recorded |
14 | — |
| PRIMARY Ki-67 Protein Proliferation Index |
30.8 | — |
| PRIMARY Percentage of Participants With Eastern Cooperative Oncology Group Performance Score (ECOG PS) |
68; 25; 8; 45; 40; 15 | — |
| PRIMARY Percentage of Participants With Recurrence Type |
77; 23 | — |
| PRIMARY Percentage of Participants According to Number of Metastatic Sites |
45; 36; 14; 5 | — |
| PRIMARY Percentage of Participants According to Location of Metastases |
67; 33 | — |
| PRIMARY Percentage of Participants With Non-Visceral Location of Metastases |
67; 33 | — |
| PRIMARY Number of Participants According to Metastatic Sites With Locoregional Recurrence |
5; 3; 2; 1; 2; 16 | — |
| PRIMARY Duration of Disease at Initiation of Palbociclib |
225.9 | — |
| PRIMARY Percentage of Participants Who Received Chemotherapy in Adjuvant or Neoadjuvant Setting |
46 | — |
| PRIMARY Percentage of Participants Who Received Chemotherapy in Advanced, Disease Modifying or Metastatic Setting |
15 | — |
| PRIMARY Number of Lines of Prior Chemotherapy for Metastatic Disease |
1.4 | — |
| PRIMARY Percentage of Participants Who Received Luteinizing Hormone Releasing Hormone (LHRH) or Chemotherapy |
96 | — |
| PRIMARY Percentage of Participants Who Received Endocrine Therapy in Adjuvant or Neoadjuvant Setting |
61 | — |
| PRIMARY Number of Participants With Types of Endocrine Therapy in Adjuvant or Neoadjuvant Setting |
19; 11; 16; 86; 5; 2 | — |
| PRIMARY Percentage of Participants Who Received Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting |
38 | — |
| PRIMARY Percentage of Participants With Type of Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting |
4; 13; 3; 54; 12; 14 | — |
| PRIMARY Number of Lines of Prior Endocrine Therapy for Metastatic Disease |
1.4 | — |
| PRIMARY Number of Participants Who Received Radiotherapy in Advanced, Disease Modifying or Metastatic Setting |
53 | — |
| PRIMARY Percentage of Participants Who Received Concomitant Medications |
100 | — |
| PRIMARY Number of Participants With Concomitant Medications Prescribed Along With Goserelin |
1; 10; 1; 4; 1 | — |
| PRIMARY Number of Participants According to Number of Prior Treatments in Metastatic Setting |
83; 58; 24; 12; 7; 4 | — |
| PRIMARY Number of Participants According to Number of Prior Chemotherapy and Hormone Therapy in Metastatic Setting |
108; 46; 24; 6; 6; 1 | — |
| PRIMARY Number of Participants According to Number of Prior Chemotherapies in Metastatic Setting |
162; 19; 7; 3 | — |
| PRIMARY Number of Participants According to Number of Prior Hormone Therapies in Metastatic Setting |
118; 52; 17; 3; 1 | — |
| SECONDARY Percentage of Participants With Their Starting Dose of Palbociclib |
97; 3 | — |
| SECONDARY Percentage of Participants Who Received Endocrine Therapy Along With Palbociclib |
3; 7; 1; 89 | — |
| SECONDARY Percentage of Participants With Dose Reductions and Treatment Discontinuation |
41; 54 | — |
| SECONDARY Number of Participants With Reasons for Palbociclib Discontinuation |
3; 1; 1; 83; 15 | — |
| SECONDARY Percentage of Participants With Temporary Discontinuation |
40 | — |
| SECONDARY Percentage of Participants According to Time to Dose Reduction in First Line Therapy |
19; 11; 12 | — |
| SECONDARY Time to Palbociclib Discontinuation |
8.3 | — |
| SECONDARY Number of Participants With First 3 Lines of Treatment After Progression |
80; 42; 20 | — |
| SECONDARY Doses Prescribed for First 3 Lines of Treatment After Progression |
909.4; 560.6; 362.4 | — |
| SECONDARY Duration of First 3 Lines of Treatment After Progression |
77.0; 67.0; 42 | — |
| SECONDARY Number of Completed Cycles of Palbociclib |
15.0 | — |
| SECONDARY Percentage of Participants Who Received Letrozole and Fulvestrant With Palbociclib |
89; 1 | — |
| SECONDARY Percentage of Participants With Progression Free Survival Following Palbociclib Initiation |
53 | — |
| SECONDARY Percentage of Participants Alive Following Palbociclib Initiation |
71 | — |
| SECONDARY Percentage of Participants With Partial Response (PR) and Complete Response (CR) Following Palbociclib Initiation |
2; 40 | — |
| SECONDARY Percentage of Participants With Stable Disease (SD) Following Palbociclib Initiation |
48 | — |
| SECONDARY Progression Free Survival (PFS) |
19.5 | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY Time to Achieving Best Overall Response (BOR) |
3.5 | — |
| SECONDARY Duration of Follow-up Period |
20.8 | — |
| SECONDARY Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib |
2; 40; 7; 48; 2; 40 | — |
| SECONDARY Time to Best Response (BR) |
3.5; 3.4; 3.6; 3.9; 3.4; 3.8 | — |
| SECONDARY Time to First Response |
115.5; 93.0; 127.5; 105.0; 93.0; 166.0 | — |
| SECONDARY Percentage of Participants With Neutropenia Post-Palbociclib Initiation |
88; 40; 7 | — |
| SECONDARY Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From Clinical Notes |
11; 14; 25; 3 | — |
| SECONDARY Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From ANC Measurements |
10; 31; 40; 7 | — |
| SECONDARY Percentage of Participants According to the Severe Grade of Neutropenia |
37; 6 | — |
| SECONDARY Percentage of Participants With Febrile Neutropenia Post-Palbociclib Initiation |
3 | — |
| SECONDARY Percentage of Participants With Gastro-Intestinal Toxicities Post-Palbociclib Initiation |
16; 1; 5; 18; 12; 1 | — |
| SECONDARY Percentage of Participants With Adverse Events During Follow-up |
72 | — |
| SECONDARY Absolute Values for Hematology Parameter in First 6 Months Following Palbociclib Initiation: Hemoglobin |
120.5 | — |
| SECONDARY Absolute Values for Hematology Parameters in First 6 Months Following Palbociclib Initiation: White Blood Cell, Absolute Neutrophil Counts and Platelet Counts |
4; 2; 233.6 | — |
| SECONDARY Absolute Values for Liver Function Parameters in First 6 Months Following Palbociclib Initiation: Aspartate Aminotransferase, Alanine Aminotransferase and Alkaline Phosphatase |
26.9; 24.5; 100.8 | — |
| SECONDARY Absolute Values for Liver Function Parameter in First 6 Months Following Palbociclib Initiation: Albumin |
42.8 | — |
| SECONDARY Absolute Values for Liver Function Parameter in First 6 Months Following Palbociclib Initiation: Bilirubin |
6.9 | — |
| SECONDARY Absolute Values for Bone Profile Parameters in First 6 Months Following Palbociclib Initiation: Calcium and Phosphate |
2.3; 1.1 | — |
| SECONDARY Absolute Values for Clinical Chemistry Parameters in First 6 Months Following Palbociclib Initiation: Potassium, Sodium and Urea |
4.3; 139.4; 5.8 | — |
| SECONDARY Absolute Values for Clinical Chemistry Parameter in First 6 Months Following Palbociclib Initiation: Creatinine |
70.6 | — |
| SECONDARY Percentage of Participants With Inpatient Admissions and Outpatient Visits |
28; 77 | — |
| SECONDARY Number of Inpatient Admissions Per Participant |
1.4 | — |
| SECONDARY Number of Outpatient Visits Per Participant |
9.5 | — |
| SECONDARY Percentage of Participants With Type of Hospital Admission |
86; 14 | — |
| SECONDARY Percentage of Participants With Reasons for Hospital Admission |
5; 8; 1; 1; 1; 1 | — |
| SECONDARY Duration of Inpatient Hospital Stay |
3 | — |
| SECONDARY Reasons of Outpatient Visit |
40; 3; 1; 44; 1; 27 | — |
| SECONDARY Type of Health Care Professional Consultations During Outpatient Visit |
47; 772; 284; 7; 209; 45 | — |
| SECONDARY Percentage of Participants Contacted Cancer National Service (CNS) and Acute Oncology Service (AOS) During First Year After Palbociclib Initiation |
36; 19 | — |
| SECONDARY Percentage of Participants According to Number of CNS Interactions |
17; 26; 19; 13; 1; 4 | — |
| SECONDARY Number of AOS Interactions Per Participant |
2.1 | — |
| SECONDARY Type of CNS and AOS Interactions |
124; 133; 8; 49; 25 | — |
| SECONDARY Reasons for CNS and AOS Interaction |
157; 2; 2; 44; 44; 8 | — |
Eligibility Criteria
Inclusion criteria
All patients meeting the following eligibility criteria will be included in the study:
- Patients enrolled into the IPP at one of the selected hospitals (see Annex 1 for IPP enrolment letter).
- Patients who received ≥1 dose of palbociclib as part of the IPP at one of the selected sites.
- For sites where data collection is performed by pH Associates, written informed consent will be required from living patients to access their medical records.
- Patient aged ≥18 years old at enrollment into the IPP
Data sourced from ClinicalTrials.gov (NCT03921866). 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.