Safety and efficacy of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ Breast Cancer patients

• Conditions: ER+ Breast cancer; MedDRA version: 15.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-23
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)
Histological confirmation of Breast Cancer with documented ER+ receptor status
Safety run-in: Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal AI

Randomised phase IIa: Received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both). Chemotherapy administered in the adjuvant setting is permitted.
Randomised phase IIa: Mandatory provision of tumour sample to confirm FGFR1 polysomy or gene amplification
At least one measurable lesion that can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits

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

Prior exposure to exemestane (safety run-in) / fulvestrant (randomised phase IIa), or any agent known to inhibit FGFRs.
More than 1 prior regimen of chemotherapy for breast cancer
ECG recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction
History of hypersensitivity to active or inactive excipients of AZD4547 or exemestane (safety run-in ) or fulvestrant (Randomised phase), including castor oil, or drugs with a similar chemical structure or class to AZD4547 or exemestane or fulvestrant.
Randomised phase IIa: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks

Study & Design

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