Aromasin Vs Arimidex Study As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer

A Randomized, Double-Blind, Controlled Study Of Exemestane (Aromasin) Vs Anastrozole (Arimidex) As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00143390

Enrollment

298

Registered

2005-09-02

Start date

2005-04-30

Completion date

2010-12-31

Last updated

2012-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Brief summary

To verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (TTP), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer.

Interventions

DRUGexemestane

take orally one tablet per day of exemestane 25 mg and one tablet per day of anastrozole placebo daily after meal

DRUGanastrozole

take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Have histologically or cytologically confirmed breast cancer at original diagnosis. At study entry, the patient must have metastatic progressive or locally recurrent inoperable breast cancer.

Exclusion criteria

* Having received any hormonal therapy (e.g., Tamoxifen, LHRH-agonists) ovariectomy or any chemotherapy for advanced/recurrent breast cancer

Design outcomes

Primary

Measure	Time frame	Description
Time to Progression (TTP) - Expert Evaluation Committee Assessment	Up to 2008 days of the treatment	Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).

Secondary

Measure	Time frame	Description
Time to Progression (TTP) - Investigators Assessment	Up to 2008 days of the treatment	Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the investigator using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).
Number of Participants With Objective Response - Investigators Assessment	Up to 2008 days of the treatment	Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Objective Response (OR)= CR + PR.
Number of Participants With Clinical Benefit - Investigator Assessment	Up to 2008 days of the treatment	Number of participants with clinical benefit based assessment of CR, PR or long-term stable disease (SD) according to the RECIST (version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Long-term SD was defined as SD lasted for at least 24 weeks (168 days). Clinical benefit = CR + PR + long SD
Overall Survival (OS)	Up to 2008 days of the treatment	OS is defined as time from the date of randomization to the date of death.
Time to Treatment Failure (TTF)	Up to 2008 days of the treatment	TTF is defined as the time from the randomization to the date of the first documentation of progressive disease (PD), symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons.

Countries

Japan

Participant flow

Participants by arm

Arm	Count
Exemestane One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.	149
Anastrozole One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.	149
Total	298

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	9	8
Overall Study	Death	2	0
Overall Study	Not meeting entry criteria	2	5
Overall Study	Other	1	2
Overall Study	Progressive disease	119	115
Overall Study	Protocol Violation	2	0
Overall Study	Study termination	10	15
Overall Study	Withdrawal by Subject	4	4

Baseline characteristics

Characteristic	Exemestane	Anastrozole	Total
Age, Customized 18-44 years old	2 participants	0 participants	2 participants
Age, Customized 45-64 years old	86 participants	88 participants	174 participants
Age, Customized >=65 years old	61 participants	61 participants	122 participants
Sex: Female, Male Female	149 Participants	149 Participants	298 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	120 / 149	119 / 149
serious Total, serious adverse events	19 / 149	19 / 149

Outcome results

Primary

Time to Progression (TTP) - Expert Evaluation Committee Assessment

Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).