N/A
Completed N=99
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
Source: ClinicalTrials.gov NCT04736576 ↗Enrolled (actual)
99
Serious AEs
3.0%
Results posted
Nov 2024
Primary outcomePrimary: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (Items) [EORTC-QLQ-C30] Global Health Status (GHS) Sub-scale Score for Cycle 1 — 0.77; -0.42 Units on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (Items) [EORTC-QLQ-C30] Global Health Status (GHS) Sub-scale Score for Cycle 1 |
0.77; -0.42 | — |
| PRIMARY Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 2 |
6.08; 0.42 | — |
| PRIMARY Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 3 |
8.00; 5.70 | — |
| PRIMARY Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 4 |
6.62; -0.93 | — |
| PRIMARY Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 5 |
4.23; -2.78 | — |
| PRIMARY Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 6 |
4.78; 2.94 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 1 |
18; 13 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 2 |
8; -32 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 3 |
12; -8 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 4 |
-5; -43 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 5 |
-7; -50 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 6 |
-13; -27 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 7 |
-9; -67 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 8 |
-5; -29 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 9 |
-8; -20 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 10 |
-8; -4 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 11 |
-16; -57 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 12 |
-5; -66 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 13 |
-10; -14 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 14 |
-7; -14 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 15 |
-10; -60 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 16 |
-3; -45 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 17 |
-6; -18 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 18 |
2; -24 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 19 |
-2; -39 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 20 |
-6; -64 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 21 |
11; -32 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 22 |
2; -46 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 23 |
-1; -70 | — |
| PRIMARY Change From Baseline in Sedentary Time Wearing at Week 24 |
-22; -102 | — |
| SECONDARY Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 |
-1.58; -2.33; 3.15; 1.33; 1.53; 1.75 | — |
| SECONDARY Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 |
0.15; -1.11; -2.4; -0.56; -3.3; -4.68 | — |
| SECONDARY Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 |
-164; -340; 0; -39; -17; -397 | — |
| SECONDARY Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 |
-1; -7; -1; -9; -4; -10 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events |
68; 5; 3; 0; 54; 1 | — |
| SECONDARY Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) |
27; 5; 32; 10; 11; 4 | — |
| SECONDARY Number of Participants According to Fatigue Interference Based on PRO-CTCAE |
33; 6; 30; 10; 8; 2 | — |
| SECONDARY Number of Participants According to Pain Severity Based on PRO-CTCAE |
22; 10; 33; 6; 16; 4 | — |
| SECONDARY Number of Participants According to Pain Interference Based on PRO-CTCAE |
39; 12; 24; 6; 8; 2 | — |
| SECONDARY Number of Participants According to Pain Frequency Based on PRO-CTCAE |
18; 8; 14; 4; 34; 6 | — |
| SECONDARY Sedentary Time Before and After Disease Progression: Group 1 and 2 Pooled |
574; 594 | — |
| SECONDARY Steps Taken Before and After Disease Progression: Group 1 and 2 Pooled |
3601; 3599 | — |
| SECONDARY MVPA Before and After Disease Progression: Group 1 and 2 Pooled |
73; 75 | — |
| SECONDARY EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled |
69.4; 53.3; 80.6; 68.0; 86.1; 65.0 | — |
| SECONDARY Number of Participants With Treatment Satisfaction |
1; 1; 40; 10; 27; 5 | — |
| SECONDARY Number of Participants According to Starting Dose of Palbociclib Treatment |
73; 5; 0 | — |
| SECONDARY Number of Participants Who Had Any Palbociclib Dose Reduction |
44 | — |
| SECONDARY Number of Participants Who Had Any Palbociclib Dose Interruption |
31 | — |
| SECONDARY Number of Participants With Cycle Delay in Palbociclib Treatment |
58 | — |
Eligibility Criteria
Inclusion Criteria
- Adult women (≥ 20 years of age)
- Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to resection or radiation therapy with curative intent.
- Documented evidence of HR+/HER2- tumor based on the patient's surgical specimen or most recent tumor biopsy.
- Initiating first or second line treatment at study entry with one of the following therapies:
palbociclib plus endocrine therapy or endocrine monotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status = 0~1.
- Owns or has regular access to an Apple iPhone or Android phone.
- Willing and able to complete collection of data via smartphone-based application.
- Willing and able to wear the wearable device for approximately 6 months.
- Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- Able to read and understand Japanese
Exclusion Criteria
- 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.
- The patient is on active treatment for other malignancies other than ABC.
- 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
Data sourced from ClinicalTrials.gov (NCT04736576). 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.