A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Randomized, Open-label Study of the Effect of Herceptin Plus Arimidex Compared With Arimidex Alone on Progression-free Survival in Patients With HER2-positive and Hormone-receptor Positive Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022672
• Other study ID #: BO16216
• Status: Completed
• Phase: Phase 3
• First received: August 10, 2001
• Last updated: June 7, 2013
• Start date: January 2001
• Est. completion date: October 2009

Study information

• Verified date: June 2013
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

Other known NCT identifiers

• NCT00112450

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• postmenopausal women;

• metastatic breast cancer suitable for endocrine therapy;

• positive hormone receptor status;

• Human epidermal growth factor receptor 2 (HER2) overexpression.

Exclusion Criteria:

• patients on hormone replacement therapy;

• previous chemotherapy for metastatic disease;

• uncontrolled cardiac disease and history of cardiac failure.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• trastuzumab (Herceptin®)
4mg/kg iv loading dose, followed by 2mg/kg iv weekly
• anastrazole (Arimidex®)
1 mg tablet taken orally daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Bulgaria,  Canada,  China,  France,  Germany,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Lithuania,  Mexico,  Netherlands,  Norway,  Poland,  Russian Federation,  South Africa,  Spain,  Sweden,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm^2) an increase of 1.0 cm^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.	24 Months, End of Study (Up to 5 years)	No
Secondary	Percentage of Participants With Clinical Benefit	Clinical Benefit was defined as stable disease for = six months or complete response or partial response.	24 Months, End of Study (Up to 5 years)	No
Secondary	Duration of Response at 24 Months	Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.	24 Months	No
Secondary	Time to Response at 24 Months	Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.	24 Months	No
Secondary	Overall Survival at 24 Months	Overall Survival is defined as the number of days from randomization to death.	24 Months	No
Secondary	Percentage of Participants With Two-Year Survival		24 Months	No
Secondary	Percentage of Participants With Overall Tumor Response at 24 Months	Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.	24 Months	No
Secondary	Percentage of Participants With Best Tumor Response at 24 Months	Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.	24 Months	No
Secondary	Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Final Visit Compared to Baseline	Participants rated their performance status using the ECOG Questionnaire on the following scale: 0=Fully active, perform all pre-disease activities without restriction; 1=Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=Ambulatory, capable of self-care, unable to carry out any work activities, up and about more than >50% of waking hours; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled, not capable of any self-care, totally confined to bed or chair; 5=Dead.; The percentage of participants in the following categories: Improved: Score decrease from baseline. Unchanged: Score the same as baseline. Worse: Score increase from baseline.	Baseline, Final Visit (Up to 24 Months)	No
Secondary	Duration of Response at End of Study	Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.	End of Study (Up to 5 years)	No
Secondary	Time to Response at End of Study	Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.	End of Study (Up to 5 years)	No
Secondary	Percentage of Participants With Overall Tumor Response at End of Study	Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.	End of Study (Up to 5 years)	No
Secondary	Percentage of Participants With Best Tumor Response at End of Study	Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.	End of Study (Up to 5 years)	No
Secondary	Number of Participants With Adverse Events	Number of participants with adverse events as a measure for safety as assessed by the collection of adverse events, laboratory tests for Hematology and Serum Chemistry, clinical assessments and cardiac monitoring.	Throughout the Study (Up to 5 years)	No