A Phase II Trial of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in Participants With Breast Cancer (MK-8669-064)

• ClinicalTrials.gov Identifier: NCT01605396
• Recruitment Status: Completed
• First Posted: May 24, 2012
• Results First Posted: March 25, 2019
• Last Update Posted: March 25, 2019
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Breast Neoplasms
• Interventions: Drug: Ridaforolimus; Drug: Dalotuzumab; Drug: Exemestane
• Enrollment: 80

Participant Flow

Recruitment Details
Pre-assignment Details	Of 196 screened participants, 80 were randomized to either ridaforolimus plus dalotuzumab plus exemestane or ridaforolimus plus exemestane.

Arm/Group Title	Ridaforolimus + Dalotuzumab + Exemestane	Ridaforolimus + Exemestane
Arm/Group Description	Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity.	Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.
Period Title: Overall Study
Started	40	40
Treated	39	40
Completed	0	0
Not Completed	40	40
Reason Not Completed
Adverse Event	5	3
Lost to Follow-up	1	0
Non-Compliance With Study Drug	1	1
Physician Decision	2	2
Progressive Disease	23	27
Withdrawal by Subject	4	2
Transfer Off Study	4	5

Baseline Characteristics

Arm/Group Title		Ridaforolimus + Dalotuzumab + Exemestane	Ridaforolimus + Exemestane	Total
Arm/Group Description		Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity.	Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.	Total of all reporting groups
Overall Number of Baseline Participants		40	40	80
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	40 participants	40 participants	80 participants
		60.7 (9.0)	57.7 (11.8)	59.2 (10.6)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	40 participants	40 participants	80 participants
	Female	40 100.0%	40 100.0%	80 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	40 participants	40 participants	80 participants
	Hispanic or Latino	4 10.0%	4 10.0%	8 10.0%
	Not Hispanic or Latino	35 87.5%	34 85.0%	69 86.3%
	Unknown or Not Reported	1 2.5%	2 5.0%	3 3.8%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	40 participants	40 participants	80 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	9 22.5%	14 35.0%	23 28.7%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	2 5.0%	1 2.5%	3 3.8%
	White	26 65.0%	24 60.0%	50 62.5%
	More than one race	3 7.5%	1 2.5%	4 5.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	1. Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR)
Description	PFS was defined as the time from randomization to progressive disease, or death, whichever occurs first. Response was assessed according to RECIST 1.1 by BICR. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% confidence interval [CI]) in weeks was reported for each treatment arm. Per protocol, participants remained on assigned treatment until disease progression. Participants who discontinued study treatment for reasons other than disease progression continued to be assessed by imaging until objective documentation of progression. All participants (including participants who discontinued study treatment) were followed for survival until investigator notification to discontinue.
Time Frame	From Day 1 through last post-study efficacy follow-up (up to ~19 months)

Outcome Measure Data

Analysis Population Description

All randomized participants.

Arm/Group Title	Ridaforolimus + Dalotuzumab + Exemestane	Ridaforolimus + Exemestane
Arm/Group Description:	Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity.	Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed	40	40
Median (95% Confidence Interval); Unit of Measure: Weeks
	23.29; (8.71 to 38.43)	31.86; (16.00 to 39.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ridaforolimus + Dalotuzumab + Exemestane, Ridaforolimus + Exemestane
	Comments	Hazard ratio (HR) and p-value for treatment difference based on Cox regression model with Efron tie handling for treatment comparison (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.565
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 80%; 0.81 to 1.72
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Percent Change From Baseline in Sum of Target Lesion Diameters at Week 16
Description	The percent change from baseline to Week 16 in the sum of target lesion diameters as determined by anatomic imaging was defined as the line length (i.e., diameter) for each target lesion identified at baseline summed across all lesions at baseline, and separately at each post-baseline time point. The primary analysis was conducted using a constrained longitudinal data analysis (cLDA) method and target lesion measurements according to the BICR. Percent change from baseline in sum of target lesion diameters at Week 16 was reported for each treatment arm.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants with available Week 16 target lesion measurements.

Arm/Group Title	Ridaforolimus + Dalotuzumab + Exemestane	Ridaforolimus + Exemestane
Arm/Group Description:	Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity.	Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed	15	32
Mean (Standard Deviation); Unit of Measure: percent change
	-19.3 (20.4)	-10.7 (28.5)

3. Secondary Outcome

Title	3. Percentage of Participants With Objective Response (Objective Response Rate [ORR]) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR).
Description	ORR was defined as the percentage of participants whose best response was complete response (CR; disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or partial response (PR; at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR. ORR was reported for each treatment arm. Per protocol, participants remained on assigned treatment until disease progression. Participants who discontinued study treatment for reasons other than disease progression continued to be assessed by imaging until objective documentation of progression.
Time Frame	From Day 1 through last post-study efficacy follow-up (up to ~19 months)

Outcome Measure Data

Analysis Population Description

All randomized participants.

Arm/Group Title	Ridaforolimus + Dalotuzumab + Exemestane	Ridaforolimus + Exemestane
Arm/Group Description:	Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity.	Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed	40	40
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	15.0; (5.7 to 29.8)	25.0; (12.7 to 41.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ridaforolimus + Dalotuzumab + Exemestane, Ridaforolimus + Exemestane
	Comments	Miettinen and Nurminen's method was used to compare ORR between the two treatment arms (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm), and to calculate a p-value and 95% confidence interval (CI) for the difference in response rates.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.267
	Comments	[Not Specified]
	Method	Miettinen and Nurminen's Method
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference of Percentages
	Estimated Value	-10.0
	Confidence Interval	(2-Sided) 95%; -27.8 to 8.0
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Overall Survival (OS)
Description	OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of analysis were censored at the date last known to be alive. OS was analyzed using the Kaplan-Meier method and median OS (95% confidence interval [CI]) in weeks was reported for each treatment arm. Per protocol, all participants (including participants who discontinued study treatment) were followed for survival until investigator notification to discontinue.
Time Frame	From Day 1 through last post-study efficacy follow-up (up to ~19 months)

Outcome Measure Data

Analysis Population Description

All randomized participants.

Arm/Group Title	Ridaforolimus + Dalotuzumab + Exemestane	Ridaforolimus + Exemestane
Arm/Group Description:	Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity.	Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed	40	40
Median (95% Confidence Interval); Unit of Measure: Weeks
	NA [1]; (NA to NA)	NA [1]; (60.6 to NA)

[1]

Median OS could not be calculated due to an insufficient number of deaths on study (i.e. median OS was not reached).

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ridaforolimus + Dalotuzumab + Exemestane, Ridaforolimus + Exemestane
	Comments	HR and p-value for treatment difference based on Cox regression model with Efron tie handling for treatment comparison (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.562
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.38
	Confidence Interval	(2-Sided) 95%; 0.46 to 4.13
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	From Day 1 through Post Treatment visit at 4 weeks after last dose of treatment (up to ~17 months)
Adverse Event Reporting Description	All randomized participants who received at least one dose of study treatment. For nine participants who continued to receive treatment under compassionate use after database lock, safety data was not included in any study database but was reported to global safety.
Arm/Group Title	Ridaforolimus + Dalotuzumab + Exemestane		Ridaforolimus + Exemestane
Arm/Group Description	Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity.		Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.
All-Cause Mortality
	Ridaforolimus + Dalotuzumab + Exemestane		Ridaforolimus + Exemestane
	Affected / at Risk (%)		Affected / at Risk (%)
Total	1/39 (2.56%)		2/40 (5.00%)
Serious Adverse Events
	Ridaforolimus + Dalotuzumab + Exemestane		Ridaforolimus + Exemestane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/39 (20.51%)		17/40 (42.50%)
Cardiac disorders
Myocardial infarction † 1	0/39 (0.00%)	0	1/40 (2.50%)	1
Sinus tachycardia † 1	0/39 (0.00%)	0	1/40 (2.50%)	1
Gastrointestinal disorders
Diarrhoea † 1	1/39 (2.56%)	1	0/40 (0.00%)	0
Haematochezia † 1	0/39 (0.00%)	0	1/40 (2.50%)	1
Vomiting † 1	1/39 (2.56%)	1	1/40 (2.50%)	1
General disorders
Asthenia † 1	0/39 (0.00%)	0	1/40 (2.50%)	1
Disease progression † 1	0/39 (0.00%)	0	1/40 (2.50%)	1
Hepatobiliary disorders
Jaundice cholestatic † 1	0/39 (0.00%)	0	1/40 (2.50%)	1
Infections and infestations
Appendicitis † 1	0/39 (0.00%)	0	1/40 (2.50%)	1
Escherichia sepsis † 1	1/39 (2.56%)	1	0/40 (0.00%)	0
Gastroenteritis † 1	0/39 (0.00%)	0	1/40 (2.50%)	1
Ophthalmic herpes zoster † 1	0/39 (0.00%)	0	1/40 (2.50%)	1
Pneumonia † 1	0/39 (0.00%)	0	1/40 (2.50%)	1
Upper respiratory tract infection † 1	0/39 (0.00%)	0	2/40 (5.00%)	2
Urinary tract infection † 1	1/39 (2.56%)	1	0/40 (0.00%)	0
Injury, poisoning and procedural complications
Oesophagitis chemical † 1	1/39 (2.56%)	1	0/40 (0.00%)	0
Metabolism and nutrition disorders
Decreased appetite † 1	0/39 (0.00%)	0	1/40 (2.50%)	1
Hypokalaemia † 1	0/39 (0.00%)	0	1/40 (2.50%)	1
Musculoskeletal and connective tissue disorders
Chondrocalcinosis † 1	0/39 (0.00%)	0	1/40 (2.50%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system † 1	0/39 (0.00%)	0	1/40 (2.50%)	1
Neoplasm progression † 1	1/39 (2.56%)	1	1/40 (2.50%)	1
Nervous system disorders
Cognitive disorder † 1	1/39 (2.56%)	1	0/40 (0.00%)	0
Psychiatric disorders
Mood altered † 1	0/39 (0.00%)	0	1/40 (2.50%)	1
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax † 1	0/39 (0.00%)	0	1/40 (2.50%)	1
Pleural effusion † 1	1/39 (2.56%)	1	1/40 (2.50%)	1
1 Term from vocabulary, MedDRA 16.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Ridaforolimus + Dalotuzumab + Exemestane		Ridaforolimus + Exemestane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	39/39 (100.00%)		40/40 (100.00%)
Blood and lymphatic system disorders
Anaemia † 1	6/39 (15.38%)	8	9/40 (22.50%)	11
Leukopenia † 1	1/39 (2.56%)	1	3/40 (7.50%)	5
Neutropenia † 1	3/39 (7.69%)	4	3/40 (7.50%)	6
Thrombocytopenia † 1	1/39 (2.56%)	1	3/40 (7.50%)	4
Gastrointestinal disorders
Abdominal pain † 1	6/39 (15.38%)	7	4/40 (10.00%)	7
Abdominal pain upper † 1	4/39 (10.26%)	4	2/40 (5.00%)	2
Constipation † 1	7/39 (17.95%)	7	8/40 (20.00%)	11
Diarrhoea † 1	14/39 (35.90%)	31	15/40 (37.50%)	28
Dry mouth † 1	3/39 (7.69%)	3	1/40 (2.50%)	1
Dyspepsia † 1	1/39 (2.56%)	1	3/40 (7.50%)	3
Gastrooesophageal reflux disease † 1	1/39 (2.56%)	1	3/40 (7.50%)	3
Nausea † 1	9/39 (23.08%)	18	9/40 (22.50%)	11
Oral pain † 1	3/39 (7.69%)	3	1/40 (2.50%)	1
Stomatitis † 1	30/39 (76.92%)	54	36/40 (90.00%)	88
Toothache † 1	1/39 (2.56%)	1	3/40 (7.50%)	4
Vomiting † 1	8/39 (20.51%)	20	8/40 (20.00%)	8
General disorders
Asthenia † 1	10/39 (25.64%)	13	14/40 (35.00%)	15
Chest pain † 1	0/39 (0.00%)	0	3/40 (7.50%)	4
Chills † 1	2/39 (5.13%)	2	2/40 (5.00%)	2
Fatigue † 1	11/39 (28.21%)	13	7/40 (17.50%)	9
Local swelling † 1	0/39 (0.00%)	0	3/40 (7.50%)	3
Oedema peripheral † 1	3/39 (7.69%)	6	10/40 (25.00%)	12
Pyrexia † 1	4/39 (10.26%)	7	5/40 (12.50%)	5
Infections and infestations
Cellulitis † 1	2/39 (5.13%)	2	0/40 (0.00%)	0
Cystitis † 1	4/39 (10.26%)	4	0/40 (0.00%)	0
Gingivitis † 1	2/39 (5.13%)	2	2/40 (5.00%)	3
Herpes zoster † 1	0/39 (0.00%)	0	3/40 (7.50%)	3
Nasopharyngitis † 1	3/39 (7.69%)	4	3/40 (7.50%)	5
Upper respiratory tract infection † 1	1/39 (2.56%)	2	6/40 (15.00%)	6
Investigations
Alanine aminotransferase increased † 1	3/39 (7.69%)	3	3/40 (7.50%)	3
Aspartate aminotransferase increased † 1	6/39 (15.38%)	9	3/40 (7.50%)	3
Blood cholesterol increased † 1	2/39 (5.13%)	2	4/40 (10.00%)	5
Neutrophil count decreased † 1	1/39 (2.56%)	1	3/40 (7.50%)	3
Platelet count decreased † 1	1/39 (2.56%)	1	5/40 (12.50%)	5
Weight decreased † 1	3/39 (7.69%)	3	6/40 (15.00%)	6
White blood cell count decreased † 1	0/39 (0.00%)	0	3/40 (7.50%)	3
Metabolism and nutrition disorders
Decreased appetite † 1	15/39 (38.46%)	16	11/40 (27.50%)	13
Hypercholesterolaemia † 1	0/39 (0.00%)	0	3/40 (7.50%)	3
Hyperglycaemia † 1	11/39 (28.21%)	14	10/40 (25.00%)	20
Hypertriglyceridaemia † 1	0/39 (0.00%)	0	3/40 (7.50%)	3
Musculoskeletal and connective tissue disorders
Arthralgia † 1	5/39 (12.82%)	6	5/40 (12.50%)	6
Back pain † 1	2/39 (5.13%)	2	6/40 (15.00%)	7
Bone pain † 1	2/39 (5.13%)	2	0/40 (0.00%)	0
Joint swelling † 1	2/39 (5.13%)	2	0/40 (0.00%)	0
Muscle spasms † 1	7/39 (17.95%)	7	1/40 (2.50%)	1
Musculoskeletal chest pain † 1	2/39 (5.13%)	2	1/40 (2.50%)	1
Myalgia † 1	4/39 (10.26%)	4	2/40 (5.00%)	2
Pain in extremity † 1	1/39 (2.56%)	1	6/40 (15.00%)	8
Nervous system disorders
Dizziness † 1	1/39 (2.56%)	1	6/40 (15.00%)	7
Dysgeusia † 1	14/39 (35.90%)	16	6/40 (15.00%)	6
Headache † 1	6/39 (15.38%)	6	13/40 (32.50%)	18
Neuropathy peripheral † 1	2/39 (5.13%)	2	1/40 (2.50%)	1
Tremor † 1	2/39 (5.13%)	2	1/40 (2.50%)	1
Psychiatric disorders
Anxiety † 1	1/39 (2.56%)	1	3/40 (7.50%)	3
Insomnia † 1	0/39 (0.00%)	0	4/40 (10.00%)	4
Renal and urinary disorders
Renal failure † 1	2/39 (5.13%)	2	0/40 (0.00%)	0
Reproductive system and breast disorders
Breast pain † 1	2/39 (5.13%)	3	2/40 (5.00%)	2
Respiratory, thoracic and mediastinal disorders
Cough † 1	8/39 (20.51%)	10	10/40 (25.00%)	13
Dyspnoea † 1	4/39 (10.26%)	4	8/40 (20.00%)	10
Epistaxis † 1	10/39 (25.64%)	15	4/40 (10.00%)	7
Interstitial lung disease † 1	0/39 (0.00%)	0	3/40 (7.50%)	3
Oropharyngeal pain † 1	2/39 (5.13%)	2	3/40 (7.50%)	3
Pneumonitis † 1	2/39 (5.13%)	2	3/40 (7.50%)	3
Skin and subcutaneous tissue disorders
Dermatitis † 1	2/39 (5.13%)	2	0/40 (0.00%)	0
Dermatitis acneiform † 1	2/39 (5.13%)	2	3/40 (7.50%)	4
Dry skin † 1	3/39 (7.69%)	3	3/40 (7.50%)	3
Erythema † 1	2/39 (5.13%)	2	2/40 (5.00%)	2
Nail disorder † 1	0/39 (0.00%)	0	3/40 (7.50%)	4
Onycholysis † 1	2/39 (5.13%)	2	2/40 (5.00%)	2
Pruritus † 1	1/39 (2.56%)	2	5/40 (12.50%)	7
Rash † 1	8/39 (20.51%)	12	8/40 (20.00%)	13
Skin lesion † 1	1/39 (2.56%)	1	3/40 (7.50%)	3
Vascular disorders
Hypertension † 1	2/39 (5.13%)	2	4/40 (10.00%)	5
Lymphoedema † 1	1/39 (2.56%)	1	4/40 (10.00%)	4
1 Term from vocabulary, MedDRA 16.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.

Results Point of Contact

• Name/Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.
• Phone: 1-800-672-6372
• EMail: ClinicalTrialsDisclosure@merck.com

Publications of Results:

Rugo HS, Tredan O, Ro J, Morales SM, Campone M, Musolino A, Afonso N, Ferreira M, Park KH, Cortes J, Tan AR, Blum JL, Eaton L, Gause CK, Wang Z, Im E, Mauro DJ, Jones MB, Denker A, Baselga J. A randomized phase II trial of ridaforolimus, dalotuzumab, and exemestane compared with ridaforolimus and exemestane in patients with advanced breast cancer. Breast Cancer Res Treat. 2017 Oct;165(3):601-609. doi: 10.1007/s10549-017-4375-5. Epub 2017 Jul 5.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT01605396
• Other Study ID Numbers: 8669-064; 2012-000335-11 ( EudraCT Number ); MK-8669-064 ( Other Identifier: Merck )
• First Submitted: May 22, 2012
• First Posted: May 24, 2012
• Results First Submitted: February 15, 2019
• Results First Posted: March 25, 2019
• Last Update Posted: March 25, 2019