Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fulvestrant

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Fulvestrant 250 mg (intramuscular injection 250 mg)

Fulvestrant 250 mg (+ 250 mg loading regimen)

Fulvestrant 500 mg (intramuscular injection 500 mg)

AstraZeneca Breast Cancer Established Brands Team Medical Science Director, MD

This study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer.

A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg

Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy

Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1).

Time from randomisation until objective disease progression or death (in the absence of objective progression) using the Kaplan-Meier method. RECIST tumor assessments were carried out every 12 weeks until progression.

DoR was defined as the time from date of first documentation of the response (CR or PR) until the date of disease progression or death from any cause.

CBR was defined as the proportion of all randomised patients who had clinical benefit (response of CR, PR or SD\>=24 weeks.

A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean.

A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean. The mean estimate of volume of distribution at steady state was reported as the sum of V1/F and V2/F in the clinical study report.

AstraZeneca

1 patient in the 250mg + LD arm was randomised but did not receive any randomised therapy. This patient is included in the efficacy summaries but is excluded from the safety summaries.

All-Cause Mortality: patients who died whilst on study treatment or during 56 days after the last fulvestrant injection.

Serious Adverse Events: Patients with SAE other than death are reported.

NOTE: Other Adverse Events include serious and non-serious AEs.

Fulvestrant 250 mg

Fulvestrant 250 mg + Loading Dose

Fulvestrant 500 mg

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Gerard Lynch

Objective Response (ORR)

Time to Progression (TTP)

Duration of Response (DoR)

Clinical Benefit Rate (CBR)

Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body

V1/F

V2/F

Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes

Spots Global Cancer Trial Database for A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg

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