A Two-Part, Randomized Trial of Ridaforolimus in Combination with Dalotuzumab Compared to Exemestane or Compared to Ridaforolimus or Dalotuzumab Monotherapy in Estrogen Receptor Positive Breast Cancer Patients - MK8669-041-00

Phase 1

• Conditions: Estrogen receptor positive breast cancer; MedDRA version: 9.1 Level: LLT Classification code 10057654

• Registration Number: EUCTR2010-019867-13-IT
• Lead Sponsor: MERCK & CO., INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-28
• Study Completion: 2013-10-15
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 115

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

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