A Study of Ridaforolimus (MK-8669) in Combination With Dalotuzumab (MK-0646) Compared to Standard of Care Treatment in Estrogen Receptor Positive Breast Cancer Patients (MK-8669-041 AM3)

Summary

This is a two-part study that will determine, if: 1) the combination of ridaforolimus and dalotuzumab will improve progression-free survival compared to exemestane; and 2) the combination of ridaforolimus and dalotuzumab will improve progression-free survival compared to both ridaforolimus and dalotuzumab as single agents, in participants with breast cancer.

Timeline

Start

2010-09-17

Primary completion

2013-10-15

Completion

2013-10-15

Outcome

Missed primary endpoint

paper hazard ratio = 1.00; P = 0.5. PMID 28324268 ↗

paper The combination of ridaforolimus plus dalotuzumab was no more effective than exemestane in patients with advanced ER-positive breast cancer PMID 28324268 ↗

Publications

• Results Baselga J, Morales SM, Awada A, Blum JL, Tan AR, Ewertz M, Cortes J, Moy B, Ruddy KJ, Haddad T, Ciruelos EM, Vuylsteke P, Ebbinghaus S, Im E, Eaton L, Pathiraja K, Gause C, Mauro D, Jones MB, Rugo HS. A phase II study of combined ridaforolimus and dalotuzumab compared with exemestane in patients with estrogen receptor-positive breast cancer. Breast Cancer Res Treat. 2017 Jun;163(3):535-544. doi: 10.1007/s10549-017-4199-3. Epub 2017 Mar 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Exemestane	Small molecule	25 mg	Oral
Subject	dalotuzumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	ridaforolimus	Small molecule	10 mg	Oral
Subject	ridaforolimus	Small molecule	20 mg	Oral
Subject	ridaforolimus	Small molecule	30 mg	Oral
Subject	ridaforolimus	Small molecule	40 mg	Oral

Indications