Trial Outcomes & Findings for Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer (NCT NCT00244933)
NCT ID: NCT00244933
Last Updated: 2023-06-22
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
every 2 courses until disease progression or death, up to 24 weeks
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
Gemcitabine, Genistein (Novasoy), Tumor Biopsy
Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
genistein: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
gemcitabine: Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days
Tumor biopsy: Biopsy of tumor prior to dose of genistein (Novasoy)
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Gemcitabine, Genistein (Novasoy), Tumor Biopsy
Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
genistein: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
gemcitabine: Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days
Tumor biopsy: Biopsy of tumor prior to dose of genistein (Novasoy)
|
|---|---|
|
Overall Study
Not response evaluable
|
2
|
Baseline Characteristics
Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine, Genistein (Novasoy), Tumor Biopsy
n=19 Participants
Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
genistein: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
gemcitabine: Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days
Tumor biopsy: Biopsy of tumor prior to dose of genistein (Novasoy)
|
|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 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
|
0 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
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 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
United States
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 2 courses until disease progression or death, up to 24 weeksPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Gemcitabine & Genistein
n=17 Participants
Gemcitabine, genistein (Novasoy), Tumor biopsy Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
|
|---|---|
|
Objective Response Rate by RECIST Criteria Following
|
0 participants
|
Adverse Events
Gemcitabine & Genistein
Serious events: 5 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine & Genistein
n=19 participants at risk
Gemcitabine, genistein (Novasoy), Tumor biopsy Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
|
|---|---|
|
Investigations
White blood cells (WBC)
|
26.3%
5/19 • Number of events 5
|
|
Investigations
Hemoglobin (Hgb)
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Absolute neutrophil count (ANC)
|
26.3%
5/19 • Number of events 5
|
|
Investigations
Platelets
|
15.8%
3/19 • Number of events 3
|
|
Investigations
Elevated Aspartate Aminotransferase (AST)
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Elevated Alanine Aminotransferase (ALT)
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Pain
|
15.8%
3/19 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.8%
3/19 • Number of events 3
|
Other adverse events
| Measure |
Gemcitabine & Genistein
n=19 participants at risk
Gemcitabine, genistein (Novasoy), Tumor biopsy Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
|
|---|---|
|
Investigations
Hemoglobin (Hgb)
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Platelets
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Fatigue
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Elevated Alkaline Phosphate
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Pain
|
10.5%
2/19 • Number of events 2
|
|
Vascular disorders
Hot flashes
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
1/19 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place