UK Ibrance Patient Program (IPP) Study

NCT03921866 | Completed Results

• 2 other identifiers: X9001194ROIS
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 8

Brief 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?

Conditions

HR+/HER2- Locally Advanced, Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (39)

• Percentage of Participants According to Treatment Lines

  Percentage of participants according to treatment lines during anytime between breast cancer (BC) diagnosis and index date were reported in this outcome measure. Treatment lines included: 1) 1st line where, palbociclib was prescribed as the first line treatment for MBC, 2) 1st line palbociclib added to letrozole where, palbociclib was prescribed as the first line treatment along with ongoing letrozole treatment which was prescribed more than 3 months prior to initiation of palbociclib, 3) 2nd line where palbociclib was prescribed as the second or later treatment line for MBC.

  At baseline

• Time From Letrozole to Palbociclib Initiation

  Time from letrozole was defined as duration from the start date of letrozole which was ongoing at the time of palbociclib treatment initiation up to the index date.

  At baseline

• Number of Participants With Menopausal Status

  Number of participants with menopausal status as pre-menopausal, peri-menopausal, post-menopausal and not applicable (NA), during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Percentage of Participants According to Disease Free Interval at Palbociclib Initiation

  Disease free interval was defined as the time from the date of last known neo-adjuvant hormone therapy to the date of MBC diagnosis.

  At baseline

• Percentage of Participants With Primary or Recurrent Metastatic Breast Cancer Diagnosis

  Percentage of participants with de novo and recurrent metastatic disease, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Percentage of Participants With Lymph Nodes Involvement

  Percentage of participants with lymph nodes involvement during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Data for this outcome measure is also presented by de novo status.

  At baseline

• Number of Lymph Nodes Involved

  Number of lymph nodes involved during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Data for this outcome measure is also presented by de novo status.

  At baseline

• Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status

  Number of participants with estrogen, progesterone and HER2 receptor status during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Percentage of Participants Who Had Rebiopsy After Metastatic Disease Diagnosis

  Percentage of participants who had rebiopsy during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Percentage of Participants According to Tumor Stage

  Percentage of participants with tumor stages 0, 1, 2, 3 and 4, as per Tumor, Node, Metastasis (TNM) staging system, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, tumor stage 0 indicates main tumor cannot be found; tumor stages 1, 2, 3 and 4 refers to the size and/or extent of the main tumor. The higher the number, the larger the tumor and/or the more it has spread into nearby tissues. Data for this outcome measure is also presented by de novo status.

  At baseline

• Percentage of Participants According to Nodal Status

  Percentage of participants with nodal stages 0, 1, 2 and 3, as per TNM staging system, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, nodal stage 0 indicates no cancer in regional lymph nodes; nodal stages 1= cancer has spread to 1 to 3 lymph nodes; nodal stage 2= cancer has spread to 4 to 9 lymph nodes, nodal stage 3= indicates the cancer has spread to 10 or more lymph nodes. Data for this outcome measure is also presented by de novo status.

  At baseline

• Percentage of Participants According to Metastasis

  Percentage of participants with metastasis stages 0 and 1, as per TNM staging system, during anytime between MBC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, metastasis stage 0 indicates cancer has not spread to other parts of the body; metastasis stage 1 indicates that the cancer has spread to distant parts of the body. Data for this outcome measure is also presented by de novo status.

  At baseline

• Tumor Size at Palbociclib Initiation

  At baseline

• Percentage of Participants According to Tumor Grade

  Percentage of participants with tumor grades, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Grades of disease was classified as grades 1, 2 and 3. As per TNM system, grade 1= well differentiated cells, low grade; grade 2= moderately differentiated cells, intermediate grade and grade 3= poorly differentiated cells, high grade.

  At baseline

• Percentage of Participants With Ki-67 Protein Proliferation Index Recorded

  Percentage of participants with Ki-67 protein proliferation index during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. The Ki-67 protein is a cellular marker for proliferation. Ki-67 is a protein in cells that increases as cells prepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. More positive cells hasten in dividing and forming new cells. Proliferation index was measured by the percentage of cells staining for Ki-67.

  At baseline

• Ki-67 Protein Proliferation Index

  The Ki-67 protein is a cellular marker for proliferation. Ki-67 is a protein in cells that increases as cells prepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. More positive cells hasten in dividing and forming new cells. Proliferation index was measured by the percentage of cells staining for Ki-67.

  At baseline

• Percentage of Participants With Eastern Cooperative Oncology Group Performance Score (ECOG PS)

  ECOG PS measured quality of life of cancer participants on a 0 to 5 scale; 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light/sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up \>50 % of waking hours; 3= capable of only limited self-care, confined to bed/ chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. Higher scores indicated worsening of quality of life.

  At baseline

• Percentage of Participants With Recurrence Type

  Percentage of participants with recurrence type during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Percentage of Participants According to Number of Metastatic Sites

  Percentage of participants according to number of metastatic sites during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Percentage of Participants According to Location of Metastases

  Percentage of participants according to location of metastases, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Percentage of Participants With Non-Visceral Location of Metastases

  Percentage of participants with non-visceral location of metastases, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Number of Participants According to Metastatic Sites With Locoregional Recurrence

  Number of participants according to metastatic sites with locoregional recurrence, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Metastatic sites with locoregional recurrence included bone, breast, lung, pleural, regional lymph nodes and other sites.

  At baseline

• Duration of Disease at Initiation of Palbociclib

  Duration of BC disease was the time duration between date of BC disease diagnosis to palbociclib treatment initiation date.

  At baseline

• Percentage of Participants Who Received Chemotherapy in Adjuvant or Neoadjuvant Setting

  Percentage of participants who received chemotherapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Percentage of Participants Who Received Chemotherapy in Advanced, Disease Modifying or Metastatic Setting

  Percentage of participants who received chemotherapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Number of Lines of Prior Chemotherapy for Metastatic Disease

  Number of lines of prior chemotherapy for metastatic disease during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Percentage of Participants Who Received Luteinizing Hormone Releasing Hormone (LHRH) or Chemotherapy

  Percentage of participants who received LHRH or chemotherapy, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Percentage of Participants Who Received Endocrine Therapy in Adjuvant or Neoadjuvant Setting

  Percentage of participants who received endocrine therapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Number of Participants With Types of Endocrine Therapy in Adjuvant or Neoadjuvant Setting

  Number of participants with types of endocrine therapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Percentage of Participants Who Received Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting

  Percentage of participants who received endocrine therapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Percentage of Participants With Type of Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting

  Percentage of participants with type of endocrine therapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Number of Lines of Prior Endocrine Therapy for Metastatic Disease

  Number of lines of prior endocrine therapy for metastatic disease during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Number of Participants Who Received Radiotherapy in Advanced, Disease Modifying or Metastatic Setting

  Number of participants who received radiotherapy in advanced, disease modifying or metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Percentage of Participants Who Received Concomitant Medications

  Percentage of participants who received concomitant medications, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Number of Participants With Concomitant Medications Prescribed Along With Goserelin

  Number of participants with concomitant medications prescribed along with goserelin, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Goserelin is the generic drug with a brand name Zoladex.

  At baseline

• Number of Participants According to Number of Prior Treatments in Metastatic Setting

  Number of participants according to number of prior treatments in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Number of Participants According to Number of Prior Chemotherapy and Hormone Therapy in Metastatic Setting

  Number of participants according to number of prior chemotherapy and hormone therapy in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Number of Participants According to Number of Prior Chemotherapies in Metastatic Setting

  Number of participants according to number of prior chemotherapies in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

  At baseline

• Number of Participants According to Number of Prior Hormone Therapies in Metastatic Setting

  Number of participants according to number of prior hormone therapies in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

  At baseline

Secondary Outcomes (51)

• Percentage of Participants With Their Starting Dose of Palbociclib

  Data collected at index date (for a maximum period of 3 years)

• Percentage of Participants Who Received Endocrine Therapy Along With Palbociclib

  Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

• Percentage of Participants With Dose Reductions and Treatment Discontinuation

  Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

• Number of Participants With Reasons for Palbociclib Discontinuation

  Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

• Percentage of Participants With Temporary Discontinuation

  Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

Interventions

Palbociclib DRUG

Palbociclib

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women over the age of 18 who entered into the UK IPP

You may qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (8)

Royal Cornwall Hospital

Truro, Cornwall, TR1 3LQ, United Kingdom

Location

Brighton Sussex Cancer Centre

Brighton, BN2 5BB, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Guys and St Thomas' NHS Trust

London, SE1 9RT, United Kingdom

Location

Maidstone Hospital

Maidstone, ME16 9QQ, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Clatterbridge

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

Location

Newcastle Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (1)

• Palmieri C, Musson A, Harper-Wynne C, Wheatley D, Bertelli G, Macpherson IR, Nathan M, McDowall E, Bhojwani A, Verrill M, Eva J, Doody C, Chowdhury R. A real-world study of the first use of palbociclib for the treatment of advanced breast cancer within the UK National Health Service as part of the novel Ibrance(R) Patient Program. Br J Cancer. 2023 Sep;129(5):852-860. doi: 10.1038/s41416-023-02352-5. Epub 2023 Jul 19.

  PMID: 37468569 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 19, 2019
• Study Start: March 1, 2019
• Primary Completion: March 4, 2021
• Study Completion: March 4, 2021
• Last Updated: March 17, 2023
• Results First Posted: March 17, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (8)