Study to Evaluate Patient Reported Outcome (PRO) and Physical Activity in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy

NCT04736576

Last updated date
Study Location
Akita University Hospital
Akita, , 010-8543, Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Adult women (≥ 20 years of age)

2. Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to resection or radiation therapy with curative intent.

3. Documented evidence of HR+/HER2- tumor based on the patient's surgical specimen or most recent tumor biopsy.

4. Initiating first or second line treatment at study entry with one of the following therapies:

palbociclib plus endocrine therapy or endocrine monotherapy

5. Eastern Cooperative Oncology Group (ECOG) performance status = 0~1.

6. Owns or has regular access to an Apple iPhone or Android phone.

7. Willing and able to complete collection of data via smartphone-based application.

8. Willing and able to wear the wearable device for approximately 6 months.

9. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.

10. Able to read and understand Japanese

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. The patient is participating in any interventional clinical trial that includes
investigational or marketed products. Patients participating in other
investigator-initiated research or non-interventional studies can be included as long
as their standard of care is not altered by the study.


2. The patient is on active treatment for other malignancies other than ABC.


3. The patient's life style is fluctuating in weekly-basis (eg, shift-time worker), which
may have high impact on physical activity assessment based to investigator's
discretion

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Evaluate Patient Reported Outcome (PRO) and Physical Activity in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy
Official Title  ICMJE Prospective, Multicenter, Observational Study to Evaluate Patient-reported Outcome and Physical Activity Using Smartphone-based Application and Wearable Device in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy
Brief Summary The study is a prospective, multicenter, observational study to evaluate PRO and physical activity using smartphone-based application and wearable device in Japanese patients with HR+/HER2- advanced breast cancer (ABC). Patients will be enrolled into either palbociclib plus endocrine therapy group (Group 1) or endocrine monotherapy group (Group 2) based on the discretion of the treating physician under routine clinical practice. Total target number of patients is approximately one-hundred in this study (About 50 patients in each group). Enrolled patients will download a smartphone-based application for electronic PRO (ePRO), be provided access to and trained on the use of the application to complete baseline, weekly, and cycle based assessments for 6 cycles (24 weeks). In addition, enrolled patients will be provided with wearable device and requested to wear the device at all-times, except of while bathing and sleeping, for 6 cycles (24 weeks).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Breast Cancer
Intervention  ICMJE Device: Wearable device
As a low-interventional procedure, enrolled patients will be provided with wearable device and requested to wear the device at all-times, except of while bathing and sleeping, for 6 cycles (24 weeks).
Study Arms  ICMJE
  • Group 1
    Palbociclib plus endocrine therapy
    Intervention: Device: Wearable device
  • Group 2
    Endocrine monotherapy
    Intervention: Device: Wearable device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2023
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult women (? 20 years of age)
  2. Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to resection or radiation therapy with curative intent.
  3. Documented evidence of HR+/HER2- tumor based on the patient's surgical specimen or most recent tumor biopsy.
  4. Initiating first or second line treatment at study entry with one of the following therapies:

    palbociclib plus endocrine therapy or endocrine monotherapy

  5. Eastern Cooperative Oncology Group (ECOG) performance status = 0~1.
  6. Owns or has regular access to an Apple iPhone or Android phone.
  7. Willing and able to complete collection of data via smartphone-based application.
  8. Willing and able to wear the wearable device for approximately 6 months.
  9. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
  10. Able to read and understand Japanese

Exclusion Criteria:

  1. The patient is participating in any interventional clinical trial that includes investigational or marketed products. Patients participating in other investigator-initiated research or non-interventional studies can be included as long as their standard of care is not altered by the study.
  2. The patient is on active treatment for other malignancies other than ABC.
  3. The patient's life style is fluctuating in weekly-basis (eg, shift-time worker), which may have high impact on physical activity assessment based to investigator's discretion
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04736576
Other Study ID Numbers  ICMJE A5481126
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Japan Breast Cancer Research Group (JBCRG)
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Principal Investigator:Hiroko BandoDept of Breast, Thyroid and Endocrine Surgery, University of Tsukuba Hospital
PRS Account Pfizer
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP