NCT00065325 · CITED IN SOURCE DOCUMENTS

The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2015-02-24

The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: Inclusion Criteria: * Biopsy confirmation of Breast Cancer * Breast Cancer has continued to grow after having received treatment with an aromatase inhibitor * Postmenopausal women defined as a women who has stopped having menstrual periods * Evidence of hormone sensitivity * Written informed consent to participate in the trial Exclusion Criteria: * Previous treatment with Faslodex (fulvestrant) or Aromasin (exemestane) * Any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor * Treatment with an investigational or non-approved drug within one month * An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures * A history of allergies to any active or inactive ingredients of Faslodex or Exemestane (i.e. castor oil or Mannitol)
healthy Volunteers: false
maximum Age: 91 Years
minimum Age: 32 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Exemestane
intervention Names
Drug: Exemestane
label
1
type
ACTIVE_COMPARATOR
description
Fulvestrant
intervention Names
Drug: Fulvestrant
label
2
type
EXPERIMENTAL

interventions

arm Group Labels
2
description
intramuscular injection
name
Fulvestrant
other Names
Faslodex
ZD9238
type
DRUG
arm Group Labels
1
description
oral capsule
name
Exemestane
other Names
AROMASIN™
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: QUADRUPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

TREATMENT

Enrollment

count: 694
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Time to disease progression (TTP)
time Frame
after 580 Progression events accrued

secondary Outcomes

measure
Objective response rate
time Frame
after 580 Progression events accrued
measure
Overall survival
time Frame
after 580 Progression events accrued
measure
Duration of response
time Frame
after 580 Progression events accrued
measure
Clinical Benefit
time Frame
after 580 Progression events accrued
measure
Quality of Life
time Frame
after 580 Progression events accrued
measure
PK
time Frame
each visit
measure
Safety and tolerability.
time Frame
after 580 Progression events accrued

Full study description

brief Summary: The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

Source references

references

citation
Arizmendi C, Zhu Y, Khan M, Gable J, Reeve BB, King-Kallimanis B, Bell J. The FACT-GP5 as a global tolerability measure: responsiveness and robustness to missing assessments. Qual Life Res. 2024 Oct;33(10):2869-2880. doi: 10.1007/s11136-024-03740-x. Epub 2024 Jul 24.
pmid
39046616
type
DERIVED