Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fulvestrant

Exemestane

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Aromatase Inhibitors

Enzyme Inhibitors

A Randomised phase IIa: AZD4547 plus fulvestrant

Randomised phase IIa: Matching placebo plus fulvestrant

AZD4547

Placebo

A monthly intramuscular injection of a depot formulation with a loading dose 14 days after initial administration

Donal Landers

The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)

Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients

A Randomised Double-blind Phase IIa Study (With Combination Safety Run-in) to Assess the Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients With FGFR1 Polysomy or Gene Amplification Who Have Progressed Following Treatment With Prior Endocrine Therapy (Adjuvant or First-line Metastatic) (GLOW)

AstraZeneca

80 mg AZD4547 bd continuous + 25 mg exemestane

AZD4547 80mg bd Cont + Ex 25mg

40 mg AZD4547 BD continuous + 25 mg exemestane

AZD4547 40mg bd Cont + Ex 25mg

80 mg AZD4547 BD one week on/one week off + 25 mg exemestane

AZD4547 80mg bd 1w/1w + Ex 25mg

80 mg AZD4547 bd two week on/one week off + 25 mg exemestane

AZD4547 80mg bd 2w/1w + Ex 25mg

Part B: AZD4547 + Fulvestrant

Part B: Placebo + Fulvestrant

Total

Age, Continuous

< 35

35 >= - < 50

50 >= - <65

>= 65

Age, Customized

Female

Sex/Gender, Customized

Asian (Other Than Chinese And Japanese)

Not Applicable

Other

Race/Ethnicity, Customized

White

Enrolment to the Part B was terminated on 27 March 2014. Slow recruitment led to concerns that enrolment would not be completed in a realistic timeframe. This led to a business decision to terminate the enrolment.

Richard Mather

80 mg AZD4547 BD continuous + 25 mg exemestane

AZD4547 40mg Cont + Ex 25mg

80 mg AZD4547 bd one week on/one week off + 25 mg exemestane

80 mg AZD4547 BD two week on/one week off + 25 mg exemestane

All patients who receive at least one dose of study treatment (AZD4547 or exemestane)

Spots Global Cancer Trial Database for fgfr inhibition, pharmacokinetics, biomarkers