Trial Outcomes & Findings for Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases (NCT NCT00429507)
NCT ID: NCT00429507
Last Updated: 2015-11-24
Results Overview
Time to progression is measured as the time from study entry to the development of disease progression.
COMPLETED
PHASE2
12 participants
7.5 Years, Study period was March 2007 to November 2014.
2015-11-24
Participant Flow
Recruitment period: March 7, 2007 to February 4, 2010. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
Samarium 153-EDTMP + Stem Cell Transplant
Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
|
|---|---|
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Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases
Baseline characteristics by cohort
| Measure |
Samarium 153-EDTMP + Stem Cell Transplant
n=12 Participants
Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
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|---|---|
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Age, Continuous
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7.5 Years, Study period was March 2007 to November 2014.Time to progression is measured as the time from study entry to the development of disease progression.
Outcome measures
| Measure |
Samarium 153-EDTMP + Stem Cell Transplant
n=12 Participants
Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
|
|---|---|
|
Time to Progression
|
317 Days
Interval 105.0 to 1339.0
|
Adverse Events
Samarium 153-EDTMP + Stem Cell Transplant
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Samarium 153-EDTMP + Stem Cell Transplant
n=12 participants at risk
Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
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|---|---|
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Musculoskeletal and connective tissue disorders
bone pain
|
100.0%
12/12 • Adverse event collection from initiation of study drug administration through Day 27 post-transplant
|
|
Gastrointestinal disorders
nausea
|
100.0%
12/12 • Adverse event collection from initiation of study drug administration through Day 27 post-transplant
|
|
Gastrointestinal disorders
stomatitis
|
100.0%
12/12 • Adverse event collection from initiation of study drug administration through Day 27 post-transplant
|
Additional Information
Nato Ueno, MD, PhD/Professor, Breast Medical Oncology
University of Texas (UT) MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place