A Trial in Breast Cancer Patients Comparing the Treatment Combination of Ridaforolimus and Dalotuzumab with Exemestane or Ridaforolimus or Dalotuzumab Alone.

• Conditions: Estrogen receptor positive breast cancer; MedDRA version: 14.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-019867-13-SE
• Lead Sponsor: Merck Sharp & Dohme (Sweden) AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-27
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

Patient has diagnosis of breast cancer that is metastatic or locally advanced and is estrogen receptor positive and HER-2 negative

Patient is post-menopausal

Patient's cancer has recurred or progressed after prior treatment with a non-steroidal aromatase inhibitor (anastrozole or letrozole) in the adjuvant or metastatic setting and patient has received at least one line of endocrine therapy for metastatic disease OR the patient's cancer has recurred within 6 months of the last dose of anastrozole or letrozole

An archival tumor specimen is available

Patient has a performance status of 1 or less on the ECOG (Eastern Cooperative Oncology Group) performance scale

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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

Patient is receiving any other systemic tumor therapy

Patient has previously received rapamycin or rapamycin analogs

Patient has received prior treatment with IGF-1R inhibitors, PI3K inhibitors, or other experimental agents that target the PI3K, AKT, or mTOR pathways

Patient has an active infection that requires antibiotics

Patient has significant or uncontrolled cardiovascular disease

Patient has poorly controlled Type 1 or 2 diabetes mellitus

Study & Design

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