Trial Outcomes & Findings for Temsirolimus in Treating Patients With Locally Advanced or Metastatic Breast Cancer (NCT NCT00376688)
NCT ID: NCT00376688
Last Updated: 2020-02-24
Results Overview
Response evaluation criteria in solid tumors (RECIST) criteria version 1.0 was used for response evaluation. Clinical benefit rate is defined as the proportion of subjects experiencing a complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks. Evaluation of target lesions: Complete Response (CR)-- Disappearance of all target lesions; Partial Response (PR)-- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable Disease (SD)-- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Evaluation of non-target lesions: Complete Response (CR)-- Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/ Stable Disease (SD)-- Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits
COMPLETED
PHASE2
31 participants
Up to 24 months
2020-02-24
Participant Flow
Participant milestones
| Measure |
Temsirolimus
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Temsirolimus: Given IV
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Temsirolimus
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Temsirolimus: Given IV
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Temsirolimus in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Temsirolimus)
n=31 Participants
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Temsirolimus: Given IV
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsResponse evaluation criteria in solid tumors (RECIST) criteria version 1.0 was used for response evaluation. Clinical benefit rate is defined as the proportion of subjects experiencing a complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks. Evaluation of target lesions: Complete Response (CR)-- Disappearance of all target lesions; Partial Response (PR)-- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable Disease (SD)-- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Evaluation of non-target lesions: Complete Response (CR)-- Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/ Stable Disease (SD)-- Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits
Outcome measures
| Measure |
Treatment (Temsirolimus)
n=31 Participants
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Temsirolimus: Given IV
|
|---|---|
|
Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease)
|
9.7 percentage of participants
|
Adverse Events
Treatment (Temsirolimus)
Serious adverse events
| Measure |
Treatment (Temsirolimus)
n=31 participants at risk
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Temsirolimus: Given IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
2/31 • 5 years
|
|
General disorders
Death NOS
|
9.7%
3/31 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.1%
5/31 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
6.5%
2/31 • 5 years
|
|
Investigations
Platelet count decreased
|
6.5%
2/31 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
2/31 • 5 years
|
Other adverse events
| Measure |
Treatment (Temsirolimus)
n=31 participants at risk
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Temsirolimus: Given IV
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
6.5%
2/31 • 5 years
|
|
Investigations
Alkaline phosphatase increased
|
6.5%
2/31 • 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
6.5%
2/31 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.5%
2/31 • 5 years
|
|
General disorders
Fatigue
|
6.5%
2/31 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.5%
2/31 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.5%
2/31 • 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.7%
3/31 • 5 years
|
|
Investigations
Lymphocyte count decreased
|
22.6%
7/31 • 5 years
|
|
Investigations
Neutrophil count decreased
|
6.5%
2/31 • 5 years
|
|
Investigations
Platelet count decreased
|
6.5%
2/31 • 5 years
|
|
Investigations
White blood cell decreased
|
6.5%
2/31 • 5 years
|
Additional Information
Dr. Gini F. Fleming
The University of Chicago Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60