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

• Conditions: Breast Cancer; MedDRA version: 12.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2010-021220-10-FR
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-24
• Last Update Posted: 19 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

Both Safety Run In and Phase II portion:
1. Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)
2. Histological confirmation of breast cancer, with documented positive oestrogen receptor status (ER+)
3 Fulfils specific criteria for previous treatment of breast cancer:
a.Relapsing during, or within 12 months of completion of, a single regimen of adjuvant endocrine therapy with non-steroidal AI and/or tamoxifen OR
b. Progression following first line endocrine therapy with a non-steroidal AI and/or tamoxifen for advanced breast cancer

Randomised phase IIa portion only:
1. Mandatory provision of tumour biopsy for AZ approved laboratory confirmation of FGFR1 polysomy or gene amplification
2. At least one measurable lesion
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. More than one regimen of endocrine therapy for advanced breast cancer
2. Previous exposure to exemestane or any agent known to inhibit FGFRs
3. Any prior chemotherapy for advanced breast cancer
4. Abnormal cardiac function
5. Any evidence of severe or uncontrolled systemic diseases
6. Inadequate bone marrow reserve or organ function
7. Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified