Trial Outcomes & Findings for Phase II Trial of SAHA & Tamoxifen for Patients With Breast Cancer (NCT NCT00365599)
NCT ID: NCT00365599
Last Updated: 2014-11-21
Results Overview
The Objective Response Rate. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For the purposes of this study, patients were evaluated for response every 8 weeks. In addition to a baseline scan, confirmatory scans were also obtained ≥ 4 weeks following initial documentation of objective response.
COMPLETED
PHASE2
43 participants
24 weeks
2014-11-21
Participant Flow
Estrogen or progesterone receptor positive advanced breast cancer: Postmenopausal, failed first-line therapy with aromatase inhibitor or recurred within 12 months of adjuvant treatments with aromatase inhibitors; Premenopausal, recurred \>12 months after adjuvant tamoxifen or never treated with tamoxifen; Not candidate for aromatase inhibitor
Participant milestones
| Measure |
Vorinostat and Tamoxifen
Vorinostat and Tamoxifen as outlined in Intervention Descriptions
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Trial of SAHA & Tamoxifen for Patients With Breast Cancer
Baseline characteristics by cohort
| Measure |
Vorinostat and Tamoxifen
n=43 Participants
Vorinostat and Tamoxifen as outlined in Intervention Descriptions
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Customized
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: All participants
The Objective Response Rate. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For the purposes of this study, patients were evaluated for response every 8 weeks. In addition to a baseline scan, confirmatory scans were also obtained ≥ 4 weeks following initial documentation of objective response.
Outcome measures
| Measure |
Vorinostat and Tamoxifen
n=43 Participants
Vorinostat and Tamoxifen as outlined in Intervention Descriptions
|
|---|---|
|
Number of Participants With Objective Response (OR)
|
8 participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: All participants
The median response duration in months. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST).
Outcome measures
| Measure |
Vorinostat and Tamoxifen
n=43 Participants
Vorinostat and Tamoxifen as outlined in Intervention Descriptions
|
|---|---|
|
Time to Progression (TTP)
|
10.3 months
Interval 8.1 to 12.4
|
SECONDARY outcome
Timeframe: 4 years, 7 monthsPopulation: All participants
Safety evaluation according to descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Outcome measures
| Measure |
Vorinostat and Tamoxifen
n=43 Participants
Vorinostat and Tamoxifen as outlined in Intervention Descriptions
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
4 participants
|
Adverse Events
Vorinostat and Tamoxifen
Serious adverse events
| Measure |
Vorinostat and Tamoxifen
n=43 participants at risk
Vorinostat and Tamoxifen as outlined in Intervention Descriptions
|
|---|---|
|
Gastrointestinal disorders
Anorexia
|
2.3%
1/43 • Number of events 1 • 4 years, 7 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.3%
1/43 • Number of events 1 • 4 years, 7 months
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding
|
2.3%
1/43 • Number of events 1 • 4 years, 7 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
2.3%
1/43 • Number of events 1 • 4 years, 7 months
|
|
Blood and lymphatic system disorders
Platelets
|
2.3%
1/43 • Number of events 1 • 4 years, 7 months
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
2.3%
1/43 • Number of events 1 • 4 years, 7 months
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
4.7%
2/43 • Number of events 2 • 4 years, 7 months
|
Other adverse events
| Measure |
Vorinostat and Tamoxifen
n=43 participants at risk
Vorinostat and Tamoxifen as outlined in Intervention Descriptions
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia - Grade 2
|
9.3%
4/43 • Number of events 4 • 4 years, 7 months
|
|
Gastrointestinal disorders
Anorexia/weight loss - Grade 2
|
16.3%
7/43 • Number of events 11 • 4 years, 7 months
|
|
Gastrointestinal disorders
Anorexia/weight loss - Grade 3
|
9.3%
4/43 • Number of events 4 • 4 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Deep vein thrombosis/pulmonary embolish (DVT/PE) - Grade 4
|
7.0%
3/43 • Number of events 3 • 4 years, 7 months
|
|
Gastrointestinal disorders
Diarrhea - Grade 2
|
16.3%
7/43 • Number of events 8 • 4 years, 7 months
|
|
General disorders
Fatigue - Grade 2
|
18.6%
8/43 • Number of events 16 • 4 years, 7 months
|
|
General disorders
Fatigue - Grade 3
|
16.3%
7/43 • Number of events 8 • 4 years, 7 months
|
|
Metabolism and nutrition disorders
Hepatic dysfunction (alanine aminotransferase/aspartate aminotransferase [ALT/AST]) - Grade 2
|
7.0%
3/43 • Number of events 8 • 4 years, 7 months
|
|
Metabolism and nutrition disorders
Hyperglycemia - Grade 2
|
11.6%
5/43 • Number of events 11 • 4 years, 7 months
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 2
|
9.3%
4/43 • Number of events 9 • 4 years, 7 months
|
|
Blood and lymphatic system disorders
Lymphopenia - Grade 2
|
11.6%
5/43 • Number of events 16 • 4 years, 7 months
|
|
Blood and lymphatic system disorders
Lymphopenia - Grade 3
|
14.0%
6/43 • Number of events 6 • 4 years, 7 months
|
|
Gastrointestinal disorders
Nausea - Grade 2
|
18.6%
8/43 • Number of events 13 • 4 years, 7 months
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 2
|
11.6%
5/43 • Number of events 5 • 4 years, 7 months
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 3
|
16.3%
7/43 • Number of events 7 • 4 years, 7 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia - Grade 2
|
9.3%
4/43 • Number of events 7 • 4 years, 7 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia - Grade 3
|
7.0%
3/43 • Number of events 3 • 4 years, 7 months
|
Additional Information
Susan Minton, D.O.
H. Lee Moffitt Cancer Center and Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place