SAKK - a Trial to Evaluate Antitumor Efficacy of Faslodex® After Aromatase Inhibitor Failure in Advanced Breast Cancer

AstraZeneca93 enrolled

Overview

The primary objective of the study is to assess the activity of fulvestrant in postmenopausal women with advanced breast cancer failing treatment with non-steroidal or steroidal aromatase inhibitors by estimating the Clinical Benefit Rate

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Neoplasms

Interventions

FulvestrantDRUG

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * Histological/cytological confirmation of breast cancer * progression under treatment with an aromatase inhibitor * At least one measurable or non-measurable lesion Exclusion Criteria: * Prior treatment for breast cancer with more than 2 different hormonal agents * More than 1 chemotherapy for advanced disease * Presence of life-threatening metastatic visceral disease

Locations (8)

Research Site

Leuven, Belgium

Research Site

Aarau, Switzerland

Research Site

Bern, Switzerland

Research Site

Geneva, Switzerland

Outcomes

Primary Outcomes

Clinical Benefit Rate

Secondary Outcomes

Duration of clinical benefit

Time to progression

Duration of response

Time to treatment failure

Safety and tolerability

6. clinical benefit rate according to HER2/neu status

Data from ClinicalTrials.gov

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