An observational study in Neoplasm of Breast (Disorder) and Carcinoma of Prostate (Disorder), sponsored by Taipei Medical University. Completed at 2 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-04-10.
Sponsored by Taipei Medical University · Observational
Among 380 studies in Breast Neoplasms with a site in Taiwan — 70 open to participants now, 135 under way, 60 of them phase 3. Breast Neoplasms · Taiwan.
Among the 380 studies in Breast Neoplasms with a site in Taiwan, this one is the 40th largest by enrollment of the 46 observational ones that give a count, is one of 28 that started in 2018, is one of 46 observational ones, and was the 169th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →70 of the 380 studies in Breast Neoplasms with a site in Taiwan are open now. Recruiting first, the newest first:
Chung Yuan Christian University · Sites in Taiwan
Daiichi Sankyo · Sites in Taiwan, United States, Belgium and 5 more countries
CHING-RONG HUANG · Sites in Taiwan
BeOne Medicines · Sites in Taiwan, United States, Australia and 13 more countries
Hoffmann-La Roche · Sites in Taiwan, United States, Argentina and 23 more countries
A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 20 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
380 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 46 · Phase 2 98 · Phase 3 136 · Phase 4 5
First in 1996; this study’s year is marked. 28 started in 2018.
This study's enrollment of 40 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Median enrollment 222 across the 332 interventional studies, 205 across the 46 observational. Of the 183 that completed or were terminated, 103 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
237 of 380 have an industry lead sponsor. The 10 most frequent:
Taipei Medical University is the lead sponsor of 257 studies on the registry; 59 are open to participants now.
Taipei Medical University has 5 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
37 of the studies in Breast Neoplasms with a site in Taiwan that are under way reach primary completion within a year, 14 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT04639986Phase 3Gilead SciencesAsian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC) | 2026-12 |
| NCT05894239Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer | 2026-12-31 |
| NCT04873362Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy | 2027-03-31 |
| NCT05696626Phase 3LeonaBioEvaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation | 2027-04 |
Among the 380 studies in Breast Neoplasms with a site in Taiwan, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study focuses on whether or not physical activity and sleep quality correlate with the health of prostate and breast cancer patients. The activity data will be acquired using wearable actigraphy devices, which the subjects will wear for the duration of seven days. The sleep quality will be measured using a combination of actigraphy and the mandarin version of the Pittsburgh Sleep Quality Index (PSQI) and the Quality of Life Questionnaire (QLQ). By using this combination, the investigators will not only measure the objective physical activity while the patient is asleep, but also the subjective sleep quality. The questionnaire will also function as control data for the accuracy of the actigraphy device.
This study will recruit approximately 30 breast or prostate cancer patients. The participants will wear a wearable actigraphy device for 7 consecutive days, which will provide accurate and objective movement and sleep data. This data is linked to a unique Identification number (ID), which will be noted in the participant's case report. This case report also contains the participant's information and answers to the questionnaires.
Physical inactivity is a common issue amongst breast cancer patients. Previous studies have shown that physical activity can be beneficiary to both the cancer outcomes and the quality of life.
However, most comparable studies had western populations or included some participants of Asian descent at best. Given the growing importance of effective and efficient follow-up care [1] and the lack of research on physical activity and sleep quality in relation to the Quality of Life (QoL) of cancer patients in Asian countries, the investigators aim to monitor the physical activity, sleep quality and subjective QoL of Taiwanese breast- and prostate cancer patients. Hence the investigators' main research question is: "Does physical and/or sleep activity affect the quality of life of (Taiwanese) breast and prostate cancer patients?". If this would be the case, the results might cover the bases for an intervention study aimed at improving physical and/or sleep quality in these cancer patients.
This study focuses on whether or not physical activity and sleep quality correlate with the health of prostate and breast cancer patients. The activity data will be acquired using wearable actigraphy devices, which the subjects will wear for the duration of seven days. The sleep quality will be measured using a combination of actigraphy and the mandarin version of the Pittsburgh Sleep Quality Index (PSQI). By using this combination, the investigators will not only measure the objective physical activity while the patient is asleep, but also the subjective sleep quality. The questionnaire will also function as control data for the accuracy of the actigraphy device.
Lastly, the quality of life will be measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30). This will provide an insight in the quality of life of the subjects, which will enable the investigators to draw a conclusion whether or not physical activity and sleep quality are related to the quality of life.
This study will recruit approximately 30 breast or prostate cancer patients. The participants will wear a wearable actigraphy device for 7 consecutive days, which will provide accurate and objective movement and sleep data. This data is linked to a unique ID, which will be noted in the participant's case report. This case report also contains the participant's information and answers to the questionnaires.
To retrieve results from the dataset, the data analysis will be divided in two parts: correlation between sleep quality and the Quality of Life, and between physical activity and the Quality of Life. Before commencing with the analysis itself, the data will be checked for outliers and missing data.
The participants will be selected with the help of oncologists in Taiwanese hospitals, therefore all participants will be Taiwanese residents and patients of either one of the desired hospital locations in Taipei. All participants are also either breast cancer or prostate cancer patients, with a minimum age of 20 years.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The patient:
Exclusion Criteria:
The patient:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants that suffer from breast cancer.
Device: Actigraphy device
All participants that suffer from prostate cancer.
Device: Actigraphy device
Both groups will receive an actigraphy device that will passively measure their movement data.
Change will be assessed on the quality of life of breast and prostate cancer patients.
It will be measured using the scores of the Quality of Life questionnaire.
Time frame: The time frame will be 8th day after enrolment of each respondent
Change will be assessed for the influence of physical activity on the Quality of Life of breast and prostate cancer patients.
It will be measured using the physical activity data from the actigraphy device.
Time frame: The time frame will be daily for 8 days after enrolment of each respondent
Study whether sleep quality and the quality of life scores of breast and prostate cancer patients are correlated
This will be measured using a combination of the PSQI questionnaire and movement data during nighttime for the sleep quality, and the quality of life questionnaire scores.
Time frame: The time frame will be 8th day after enrollment of each respondent
Plan to share: Yes — All Individual Participant Data (IPD) will be shared as open research data after the results have been published. All data that might identify individuals will be stripped to make sure the data is completely anonymous.
Supporting information: Study protocol
Time frame: The anonymous (raw) data might be shared after the study itself has been finished.
Access criteria: The applications for IPD sharing will be reviewed on an individual basis by the Principal Investigator.
Ran from May 2018 to primary completion in Jul 2018, 2 months.
Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's 2 months is below that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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