Fulvestrant 500mg With Exemestane Endocrine Therapy for Postmenopausal Advanced Breast Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2020-12-31

Brief Summary

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A Randomized, Open label, Parallel-group, Multi-center study. Eligible patients will be randomized in a 1:1 ratio to receive fulvestrant 500 mg or Exemestane 25mg.

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Detailed Description

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To compare the efficacy and tolerability of Fulvestrant 500 mg with Exemestane 25 mg as first line endocrine therapy in postmenopausal women with oestrogen receptor positive HER2 negative advanced breast cancer who have relapsed on or after adjuvant non-aromatase inhibitor therapy

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fulvestrant

Fulvestrant 500 mg

Group Type EXPERIMENTAL

Fulvestrant 500 mg

Intervention Type DRUG

Fulvestrant 500mg will be given monthly.

Exemestane

Exemestane 25mg

Group Type ACTIVE_COMPARATOR

Exemestane 25 mg

Intervention Type DRUG

Exemestane 25mg will be given once daily.

Interventions

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Fulvestrant 500 mg

Fulvestrant 500mg will be given monthly.

Intervention Type DRUG

Exemestane 25 mg

Exemestane 25mg will be given once daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent document on file;
* Age over 60 years;
* Age \< 60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol level in the postmenopausal range;
* Patients with metastatic or locally advanced disease not amenable to therapy with Curative intent
* ER + and/or PgR +;
* Duration of adjuvant non-aromatase inhibitors treatment should be at least 2 years or more;
* WHO performance status 0, 1 or 2;
* Patients with life expectancy of more than 3 months.

Exclusion Criteria

* Presence of life-threatening metastatic visceral disease;
* Previous systemic chemotherapy for advanced breast cancer;
* Received systemic endocrine therapy for advanced disease;
* Extensive radiation therapy within the last 4 weeks ;
* Platelets \< 100\*109 / L,Total bilirubin no less than 1.5ULRR, ALT or AST no less than 2.5ULRR if no demonstrable liver metastases or no less than 5ULRR in presence of liver metastases;
* Severe renal impairment, bleeding diathesis, long-term anticoagulant therapy;
* History of hypersensitivity to active or inactive excipients of fulvestrant, Exemestane and/or castor oil.

Eligible Sex

ALL

Accepts Healthy Volunteers

No