Effect of Vandetanib on Cellular Markers in Invasive Breast Cancer

NCT01934335 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 201301763
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to examine whether treatment with vandetanib has an effect on the tumor cells in breast cancer by examining tissue markers.

Conditions

Invasive Breast Cancer

Keywords

breast cancer, TKI, tyrosine kinase inhibitor, vandetanib, Ki-67

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Ki-67 Cells Observed 2 Weeks Post-treatment

  Pre- and post-treatment samples will be assessed by immunohistochemistry for positivity for Ki-67.

  2 weeks

Secondary Outcomes (1)

• Percent Change From Baseline in TUNEL Observed 2 Weeks Post-treatment

  2 weeks

Other Outcomes (1)

• Percent Change From Baseline in RET Expression Observed 2 Weeks Post-treatment

  2 weeks

Study Arms (2)

Vandetanib

EXPERIMENTAL

Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery

Drug: Vandetanib

Placebo

PLACEBO COMPARATOR

Placebo, PO, q day for 7-14 days prior to surgery.

Other: Placebo

Interventions

Vandetanib DRUG

Also known as: ZD6474

Vandetanib

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with core breast biopsy that, on pathology review, demonstrates invasive breast cancer and are determined to need surgical excision of the lesion. All subtypes of invasive breast cancer will be enrolled. Core biopsy specimens of enrolled patients will be stained for RET by immunohistochemistry and scored, however, patients will not be excluded according to RET expression.
• Female gender
• Age \>/= 18 years of age
• ECOG performance status \</= 2
• Life expectancy of greater than 6 months
• Ability and willingness to provide informed consent to participate in study

You may not qualify if:

• Prolonged QT interval (QTc \> 480 milliseconds) on screening EKG or congenital long QT syndrome
• Any concomitant medications that are known to be associated with Torsades de Pointes or QT elongation (see appendix 2).
• Hypertension not controlled by medical therapy (systolic BP greater than 160 millimeters of mercury \[mmHg\] or diastolic blood pressure great than 100 mmHg).
• Patients taking metformin or digoxin.
• History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Patients with atrial fibrillation controlled by medication are permitted.
• Significant cardiac event (e.g., myocardial infarction), superior vena cava syndrome, New York Heart Association (NYHA) classification of heart disease ≥2 within 12 weeks, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
• Serum calcium or magnesium outside the institutional range of normal.
• Serum Potassium \< 4.0 mmol/L or above 5.0 mmol/L
• Creatinine clearance \< 50 ml/min
• PT \> 12 seconds or PTT \> 31 seconds
• Platelet count of \< 100,000
• Serum bilirubin greater than 1.5 mg/dl
• Alanine aminotransferase (ALT) \> 50 U/L, aspartate aminotransferase (AST) \> 65 U/L, or alkaline phosphatase (ALP) \> 250 U/L
• Any cytotoxic treatments, such as neoadjuvant chemotherapy, planned before subsequent surgical procedure.
• Previous exposure to Vandetanib

Sponsors & Collaborators

• Ronald Weigel: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

vandetanib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Ronald Weigel, MD, PhD
• Organization: Holden Comprehensive Cancer Center

ronald-weigel@uiowa.edu

319-353-7474

Study Officials

• Ronal Weigel, MD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 4, 2013
• Study Start: October 1, 2013
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: November 1, 2021
• Results First Posted: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)