Trial Outcomes & Findings for Phase 2 Anastrozole and Vandetanib (ZD6474) in Neoadjuvant Treatment of Postmenopausal Hormone Receptor-Positive Breast Cancer (NCT NCT00481845)
NCT ID: NCT00481845
Last Updated: 2017-02-07
Results Overview
Determine tumor objective response rate by MRI. (CR): Disappearance of the target lesion (PR): At least a 30% decrease in the longest diameter of the target lesion taking as reference the baseline LD (PD): At least a 20% increase in the LD of target lesion, taking as reference the baseline LD or the appearance of one or more new lesions (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the baseline LD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
1 year
Results posted on
2017-02-07
Participant Flow
Participant milestones
| Measure |
Vandetanib + Anastrozole
Vandetanib and Anastrozole as neoadjuvant therapy
|
Anastrozole
Anastrozole as neoadjuvant therapy
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Anastrozole and Vandetanib (ZD6474) in Neoadjuvant Treatment of Postmenopausal Hormone Receptor-Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Vandetanib + Anastrozole
n=1 Participants
Vandetanib and Anastrozole as neoadjuvant therapy
|
Anastrozole
Anastrozole as neoadjuvant therapy
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Gender
Female
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Gender
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 yearDetermine tumor objective response rate by MRI. (CR): Disappearance of the target lesion (PR): At least a 30% decrease in the longest diameter of the target lesion taking as reference the baseline LD (PD): At least a 20% increase in the LD of target lesion, taking as reference the baseline LD or the appearance of one or more new lesions (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the baseline LD.
Outcome measures
| Measure |
Vandetanib + Anastrozole
n=1 Participants
Vandetanib and Anastrozole as neoadjuvant therapy
|
Anastrozole
Anastrozole as neoadjuvant therapy
|
|---|---|---|
|
Tumor Objective Response by MRI
Complete Response- CR
|
0 Participants
|
0 Participants
|
|
Tumor Objective Response by MRI
Partial Response- PR
|
0 Participants
|
0 Participants
|
|
Tumor Objective Response by MRI
Progressive Disease- PD
|
0 Participants
|
0 Participants
|
|
Tumor Objective Response by MRI
Stable Disease-SD
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: CR+PR
Outcome measures
| Measure |
Vandetanib + Anastrozole
n=1 Participants
Vandetanib and Anastrozole as neoadjuvant therapy
|
Anastrozole
Anastrozole as neoadjuvant therapy
|
|---|---|---|
|
Pathologic Complete Response
|
0 Participants
|
0 Participants
|
Adverse Events
Vandetanib + Anastrozole
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Anastrozole
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vandetanib + Anastrozole
n=1 participants at risk
Vandetanib and Anastrozole as neoadjuvant therapy
|
Anastrozole
Anastrozole as neoadjuvant therapy
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Number of events 2 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
—
0/0 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
|
Blood and lymphatic system disorders
Hypertension
|
100.0%
1/1 • Number of events 2 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
—
0/0 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
Other adverse events
| Measure |
Vandetanib + Anastrozole
n=1 participants at risk
Vandetanib and Anastrozole as neoadjuvant therapy
|
Anastrozole
Anastrozole as neoadjuvant therapy
|
|---|---|---|
|
Cardiac disorders
Vague chest discomfort
|
100.0%
1/1 • Number of events 2 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
—
0/0 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
|
Nervous system disorders
Sweaty palms
|
100.0%
1/1 • Number of events 1 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
—
0/0 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
|
Nervous system disorders
Painic attack
|
100.0%
1/1 • Number of events 1 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
—
0/0 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 1 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
—
0/0 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
|
Gastrointestinal disorders
increasing reflux symptoms
|
100.0%
1/1 • Number of events 1 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
—
0/0 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Onset asthma symptoms
|
100.0%
1/1 • Number of events 1 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
—
0/0 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
|
Gastrointestinal disorders
esophageal spasm
|
100.0%
1/1 • Number of events 1 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
—
0/0 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
|
Gastrointestinal disorders
vomiting
|
100.0%
1/1 • Number of events 1 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
—
0/0 • 1 year
All AEs or SAEs collected during the 4 months (12 cycles) span on treatment
|
Additional Information
Mark Daniel Pegram; Susy Yuan-Huey Hung Professor
Stanford Cancer Institute, Stanford University
Phone: 650-723-5801
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place