Trial Outcomes & Findings for Efficacy of High Dose Tamoxifen to Advanced Hormone Receptor-High Expressed Breast Cancer (NCT NCT03045653)
NCT ID: NCT03045653
Last Updated: 2022-03-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
36months
Results posted on
2022-03-28
Participant Flow
Participant milestones
| Measure |
Treatment Arm
receiving a treatment of tamoxifen 100 mg/d
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of High Dose Tamoxifen to Advanced Hormone Receptor-High Expressed Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=30 Participants
receiving a treatment of tamoxifen 100 mg/d or high-dose Tamoxifen(100 mg/d ) plus chemotherapy
Tamoxifen Oral Product: Tamoxifen 100 mg/d or high-dose Tamoxifen(100 mg/d ) plus chemotherapy
|
|---|---|
|
Age, Continuous
|
45 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36monthsOutcome measures
| Measure |
Treatment Arm
n=30 Participants
receiving a treatment of tamoxifen 100 mg/d
|
|---|---|
|
Progression-free Survival (PFS)
|
5 months
Interval 2.6 to 7.3
|
Adverse Events
Treatment Arm
Serious events: 0 serious events
Other events: 7 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Arm
n=30 participants at risk
receiving a treatment of tamoxifen 100 mg/d
|
|---|---|
|
General disorders
fatigue
|
23.3%
7/30 • Number of events 7 • 2 years
|
Additional Information
Zhongyu Yuan
Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative innovation center for Cancer Medicine
Phone: +8613798027658
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place