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

• Conditions: ER+ Breast Cancer; MedDRA version: 14.0Level: 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-DE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-27
• Last Update Posted: 31 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 89

Inclusion Criteria

Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)
Histological confirmation of Breast Cancer with documented ER+
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 for advanced breast cancer. Co-administration of a targeted agent with the non-steroidal AI is permitted providing all toxicities have recovered to a CTCAE Grade 1 or below.

Randomised phase IIa: Mandatory provision of tumour biopsy for AstraZeneca approved laboratory confirmation of FGFR1 polysomy or gene amplification (FISH score 4 or more)
Randomised IIa: At least one measurable lesion that can be accurately assessed by CT/MRI 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

More than one regimen of endocrine therapy for advanced breast cancer
Safety Run-in: More than 1 prior regimen of chemo therapy
Randomised IIa: Any prior chemotherapy for advanced breast cancer
ECG recordings that demonstrate abnormalities in rhythm and function
A history of a bad reaction to AZD4547 or exemestane or medications similar in class or structure

Study & Design

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