Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT03289039

Recruitment Status : Terminated (Slow accrual)

First Posted : September 20, 2017

Results First Posted : March 21, 2023

Last Update Posted : February 13, 2024

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Sponsor:

Collaborator:

Puma Biotechnology, Inc.

Information provided by (Responsible Party):

Jose Pablo Leone, Dana-Farber Cancer Institute

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Breast Cancer
Interventions	Drug: Neratinib Drug: Fulvestrant
Enrollment	21

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Neratinib	Neratinib + Fulvestrant
Arm/Group Description	Neratinib will be administered oral...	Neratinib will be administered oral...
Arm/Group Description	Neratinib will be administered orally once daily Neratinib is dosed at 240mg (six 40mg tablets) Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)	Neratinib will be administered orally once daily Neratinib is dosed at 240mg (six 40mg tablets) Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle. Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections). Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2) Fulvestrant: Fulvestrant, works in treating breast cancer that has spread to other parts of the body
Period Title: Overall Study
Started	11	10
Completed	10	8
Not Completed	1	2
Reason Not Completed
Withdrawal by Subject	0	1
Became ineligible prior to treatment start	0	1
progressed before treatment start	1	0

Baseline Characteristics

Arm/Group Title		Neratinib	Neratinib + Fulvestrant	Total
Arm/Group Description		Neratinib will be administered oral...	Neratinib will be administered oral...	Total of all reporting groups
Arm/Group Description		Neratinib will be administered orally once daily Neratinib is dosed at 240mg (six 40mg tablets) Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)	Neratinib will be administered orally once daily Neratinib is dosed at 240mg (six 40mg tablets) Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle. Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections). Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2) Fulvestrant: Fulvestrant, works in treating breast cancer that has spread to other parts of the body	Total of all reporting groups
Overall Number of Baseline Participants		10	8	18
Baseline Analysis Population Description		...
Baseline Analysis Population Description		The analysis population is only including treated patients.
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	10 participants	8 participants	18 participants
		55 (28 to 73)	55.5 (36 to 66)	55 (28 to 73)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	10 participants	8 participants	18 participants
	Female	10 100.0%	8 100.0%	18 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	10 participants	8 participants	18 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	10 100.0%	8 100.0%	18 100.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
Race	Number Analyzed	10 participants	8 participants	18 participants
	Asian	0 0.0%	2 25.0%	2 11.1%
	Black or African American	1 10.0%	0 0.0%	1 5.6%
	Other	1 10.0%	0 0.0%	1 5.6%
	White	8 80.0%	6 75.0%	14 77.8%
Prior use of Fulvestrant Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	10 participants	8 participants	18 participants
	Yes	3 30.0%	0 0.0%	3 16.7%
	No	7 70.0%	8 100.0%	15 83.3%
Prior lines of therapy Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	10 participants	8 participants	18 participants
	Less than or equal to 3 lines	1 10.0%	1 12.5%	2 11.1%
	Greater than 3 lines	9 90.0%	7 87.5%	16 88.9%

Outcome Measures

1.Primary Outcome


Title	Progression Free Survival
Description	Progression-Free Survival (PFS) is defined as the time from randomizat...
Description	Progression-Free Survival (PFS) is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Disease assessment were conducted at baseline and every two cycles after the first cycle.
Time Frame	Participants were followed for PFS up to 20.3 months from registration.

Outcome Measure Data

Analysis Population Description

Only treated participants


Arm/Group Title		Neratinib	Neratinib + Fulvestrant
Arm/Group Description:		Neratinib will be administered oral...	Neratinib will be administered oral...
Arm/Group Description:		Neratinib will be administered orally once daily Neratinib is dosed at 240mg (six 40mg tablets) Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)	Neratinib will be administered orally once daily Neratinib is dosed at 240mg (six 40mg tablets) Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle. Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections). Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2) Fulvestrant: Fulvestrant, works in treating breast cancer that has spread to other parts of the body
Overall Number of Participants Analyzed		10	8
Median (95% Confidence Interval) Unit of Measure: months
Less than 4 prior lines of therapy; no prior use of fulvestrant	Number Analyzed	1 participants	1 participants
		19.58 ^[1] (NA to NA)	1.74 ^[1] (NA to NA)
More than 3 prior lines of therapy; no prior use of fulvestrant	Number Analyzed	7 participants	7 participants
		1.81 ^[1] (1.81 to NA)	3.84 ^[1] (1.61 to NA)
More than 3 prior lines of therapy; prior use of fulvestrant	Number Analyzed	2 participants	0 participants
		6.42 ^[1] (5.55 to NA)

[1]

The sample size for this group is too small to have a valid interval.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Neratinib, Neratinib + Fulvestrant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.98
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95% 0.27 to 4.12
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Overall Survival
Description	Overall Survival (OS) is defined as the time from randomization (or re...
Description	Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. Participants will be evaluated every 6 months for survival until death. Participants removed from protocol therapy for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
Time Frame	Participants were followed for up to 38.4 months (3 years and 2 months) from registration to removal from protocol therapy or death.

Outcome Measure Data

Analysis Population Description

Only included the treated participants.


Arm/Group Title		Neratinib	Neratinib + Fulvestrant
Arm/Group Description:		Neratinib will be administered oral...	Neratinib will be administered oral...
Arm/Group Description:		Neratinib will be administered orally once daily Neratinib is dosed at 240mg (six 40mg tablets) Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)	Neratinib will be administered orally once daily Neratinib is dosed at 240mg (six 40mg tablets) Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle. Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections). Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2) Fulvestrant: Fulvestrant, works in treating breast cancer that has spread to other parts of the body
Overall Number of Participants Analyzed		10	8
Median (95% Confidence Interval) Unit of Measure: months
Less than 4 prior lines of therapy; no prior fulvestrant use	Number Analyzed	1 participants	1 participants
		NA ^[1] (NA to NA)	12.22 ^[2] (NA to NA)
More than 3 prior lines of therapy; no prior fulvestrant use	Number Analyzed	7 participants	7 participants
		20.17 ^[2] (12.91 to NA)	19.91 ^[2] (13.63 to NA)
More than 3 prior lines of therapy; prior fulvestrant use	Number Analyzed	2 participants	0 participants
More than 3 prior lines of therapy; prior fulvestrant use		27.79 ^[2] (NA to NA)

[1]

Did not reach median survival.

[2]

Sample size too small to get a valid confidence interval.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Neratinib, Neratinib + Fulvestrant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.89
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95% 0.24 to 2.81
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Overall Response Rate
Description	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0...
Description	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Overall Response Rate(ORR) = (CR + PR)/sample size.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Neratinib	Neratinib + Fulvestrant
Arm/Group Description:	Neratinib will be administered oral...	Neratinib will be administered oral...
Arm/Group Description:	Neratinib will be administered orally once daily Neratinib is dosed at 240mg (six 40mg tablets) Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)	Neratinib will be administered orally once daily Neratinib is dosed at 240mg (six 40mg tablets) Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle. Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections). Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2) Fulvestrant: Fulvestrant, works in treating breast cancer that has spread to other parts of the body
Overall Number of Participants Analyzed	10	8
Measure Type: Count of Participants Unit of Measure: Participants
	0 0.0%	1 12.5%

4.Secondary Outcome


Title	Duration Of Responses
Description	The duration of overall response is measured from the time measurement...
Description	The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Neratinib	Neratinib + Fulvestrant
Arm/Group Description:	Neratinib will be administered oral...	Neratinib will be administered oral...
Arm/Group Description:	Neratinib will be administered orally once daily Neratinib is dosed at 240mg (six 40mg tablets) Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)	Neratinib will be administered orally once daily Neratinib is dosed at 240mg (six 40mg tablets) Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle. Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections). Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2) Fulvestrant: Fulvestrant, works in treating breast cancer that has spread to other parts of the body
Overall Number of Participants Analyzed	10	8
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: months
	NA ^[1] (NA to NA)	6.7 ^[2] (NA to NA)

[1]

No patient had a response.

[2]

There was only one patient who had a response. The duration of response is 6.7 months.

Adverse Events

Time Frame	38.4 months (3 years and 2 months)
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Neratinib	Neratinib + Fulvestrant
Arm/Group Description	Neratinib will be administered oral...	Neratinib will be administered oral...
Arm/Group Description	Neratinib will be administered orally once daily Neratinib is dosed at 240mg (six 40mg tablets) Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)	Neratinib will be administered orally once daily Neratinib is dosed at 240mg (six 40mg tablets) Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle. Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections). Neratinib: Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2) Fulvestrant: Fulvestrant, works in treating breast cancer that has spread to other parts of the body
All-Cause Mortality
	Neratinib	Neratinib + Fulvestrant
	Affected / at Risk (%)	Affected / at Risk (%)
Total	6/10 (60.00%)	7/8 (87.50%)
Serious Adverse Events Serious Adverse Events
	Neratinib	Neratinib + Fulvestrant
	Affected / at Risk (%)	Affected / at Risk (%)
Total	4/10 (40.00%)	2/8 (25.00%)
Gastrointestinal disorders
Diarrhea ^† 1	0/10 (0.00%)	1/8 (12.50%)
General disorders
Fatigue ^† 1	1/10 (10.00%)	0/8 (0.00%)
Malaise ^† 1	1/10 (10.00%)	0/8 (0.00%)
Infections and infestations
Skin infection ^† 1	0/10 (0.00%)	1/8 (12.50%)
Sepsis ^† 1	1/10 (10.00%)	0/8 (0.00%)
Investigations
CPK increased ^† 1	1/10 (10.00%)	0/8 (0.00%)
Metabolism and nutrition disorders
Anorexia ^† 1	1/10 (10.00%)	0/8 (0.00%)
Dehydration ^† 1	2/10 (20.00%)	0/8 (0.00%)
Hyponatremia ^† 1	1/10 (10.00%)	0/8 (0.00%)
Psychiatric disorders
Confusion ^† 1	1/10 (10.00%)	0/8 (0.00%)
Renal and urinary disorders
Acute kidney injury ^† 1	1/10 (10.00%)	0/8 (0.00%)
Bladder perforation ^† 1	1/10 (10.00%)	0/8 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	1/10 (10.00%)	0/8 (0.00%)
Dyspnea ^† 1	1/10 (10.00%)	0/8 (0.00%)
Hypoxia ^† 1	1/10 (10.00%)	0/8 (0.00%)
Pleural effusion ^† 1	1/10 (10.00%)	0/8 (0.00%)
Respiratory, thoracic and mediastinal disorders ^† 1	1/10 (10.00%)	0/8 (0.00%)
Vascular disorders
Hypotension ^† 1	1/10 (10.00%)	0/8 (0.00%)
1 Term from vocabulary, CTCAE (4.0) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Neratinib	Neratinib + Fulvestrant
	Affected / at Risk (%)	Affected / at Risk (%)
Total	10/10 (100.00%)	8/8 (100.00%)
Blood and lymphatic system disorders
Anemia ^† 1	2/10 (20.00%)	0/8 (0.00%)
Ear and labyrinth disorders
Hearing impaired ^† 1	1/10 (10.00%)	0/8 (0.00%)
Endocrine disorders
Adrenal insufficiency ^† 1	0/10 (0.00%)	1/8 (12.50%)
Gastrointestinal disorders
Abdominal pain ^† 1	2/10 (20.00%)	2/8 (25.00%)
Constipation ^† 1	7/10 (70.00%)	5/8 (62.50%)
Diarrhea ^† 1	8/10 (80.00%)	5/8 (62.50%)
Dyspepsia ^† 1	0/10 (0.00%)	1/8 (12.50%)
Gastroesophageal reflux disease ^† 1	2/10 (20.00%)	1/8 (12.50%)
Mucositis oral ^† 1	1/10 (10.00%)	1/8 (12.50%)
Nausea ^† 1	5/10 (50.00%)	4/8 (50.00%)
Oral pain ^† 1	0/10 (0.00%)	1/8 (12.50%)
Vomiting ^† 1	2/10 (20.00%)	2/8 (25.00%)
Flatulence ^† 1	1/10 (10.00%)	0/8 (0.00%)
Toothache ^† 1	1/10 (10.00%)	0/8 (0.00%)
General disorders
Edema limbs ^† 1	0/10 (0.00%)	1/8 (12.50%)
Fatigue ^† 1	6/10 (60.00%)	5/8 (62.50%)
Fever ^† 1	0/10 (0.00%)	1/8 (12.50%)
General disorders and administration site conditions - Other, specify ^† 1	0/10 (0.00%)	1/8 (12.50%)
Pain ^† 1	4/10 (40.00%)	4/8 (50.00%)
Malaise ^† 1	1/10 (10.00%)	0/8 (0.00%)
Non-cardiac chest pain ^† 1	1/10 (10.00%)	0/8 (0.00%)
Hepatobiliary disorders
Portal hypertension ^† 1	0/10 (0.00%)	1/8 (12.50%)
Infections and infestations
Sinusitis ^† 1	0/10 (0.00%)	1/8 (12.50%)
Skin infection ^† 1	0/10 (0.00%)	1/8 (12.50%)
Upper respiratory infection ^† 1	0/10 (0.00%)	1/8 (12.50%)
Bronchial infection ^† 1	1/10 (10.00%)	0/8 (0.00%)
Papulopustular rash ^† 1	1/10 (10.00%)	0/8 (0.00%)
Paronychia ^† 1	1/10 (10.00%)	0/8 (0.00%)
Urinary tract infection ^† 1	1/10 (10.00%)	0/8 (0.00%)
Injury, poisoning and procedural complications
Fracture ^† 1	0/10 (0.00%)	1/8 (12.50%)
Fall ^† 1	1/10 (10.00%)	0/8 (0.00%)
Investigations
Alanine aminotransferase increased ^† 1	2/10 (20.00%)	2/8 (25.00%)
Alkaline phosphatase increased ^† 1	2/10 (20.00%)	1/8 (12.50%)
Aspartate aminotransferase increased ^† 1	5/10 (50.00%)	2/8 (25.00%)
Lymphocyte count decreased ^† 1	0/10 (0.00%)	1/8 (12.50%)
Blood bilirubin increased ^† 1	1/10 (10.00%)	0/8 (0.00%)
Investigations - Other, specify ^† 1	1/10 (10.00%)	0/8 (0.00%)
Neutrophil count decreased ^† 1	1/10 (10.00%)	0/8 (0.00%)
Platelet count decreased ^† 1	1/10 (10.00%)	0/8 (0.00%)
Weight loss ^† 1	1/10 (10.00%)	0/8 (0.00%)
White blood cell decreased ^† 1	1/10 (10.00%)	0/8 (0.00%)
Metabolism and nutrition disorders
Anorexia ^† 1	1/10 (10.00%)	4/8 (50.00%)
Dehydration ^† 1	1/10 (10.00%)	0/8 (0.00%)
Hypermagnesemia ^† 1	1/10 (10.00%)	0/8 (0.00%)
Hypokalemia ^† 1	1/10 (10.00%)	0/8 (0.00%)
Hyponatremia ^† 1	1/10 (10.00%)	0/8 (0.00%)
Musculoskeletal and connective tissue disorders
Back pain ^† 1	3/10 (30.00%)	3/8 (37.50%)
Pain in extremity ^† 1	0/10 (0.00%)	2/8 (25.00%)
Arthralgia ^† 1	1/10 (10.00%)	0/8 (0.00%)
Bone pain ^† 1	1/10 (10.00%)	0/8 (0.00%)
Generalized muscle weakness ^† 1	2/10 (20.00%)	0/8 (0.00%)
Neck pain ^† 1	1/10 (10.00%)	0/8 (0.00%)
Osteonecrosis of jaw ^† 1	2/10 (20.00%)	0/8 (0.00%)
Nervous system disorders
Headache ^† 1	1/10 (10.00%)	1/8 (12.50%)
Memory impairment ^† 1	0/10 (0.00%)	1/8 (12.50%)
Peripheral motor neuropathy ^† 1	2/10 (20.00%)	1/8 (12.50%)
Peripheral sensory neuropathy ^† 1	0/10 (0.00%)	2/8 (25.00%)
Dizziness ^† 1	1/10 (10.00%)	0/8 (0.00%)
Lethargy ^† 1	1/10 (10.00%)	0/8 (0.00%)
Psychiatric disorders
Anxiety ^† 1	1/10 (10.00%)	2/8 (25.00%)
Depression ^† 1	2/10 (20.00%)	2/8 (25.00%)
Insomnia ^† 1	2/10 (20.00%)	2/8 (25.00%)
Confusion ^† 1	1/10 (10.00%)	0/8 (0.00%)
Renal and urinary disorders
Acute kidney injury ^† 1	1/10 (10.00%)	0/8 (0.00%)
Reproductive system and breast disorders
Dyspareunia ^† 1	0/10 (0.00%)	1/8 (12.50%)
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis ^† 1	1/10 (10.00%)	1/8 (12.50%)
Cough ^† 1	2/10 (20.00%)	1/8 (12.50%)
Nasal congestion ^† 1	0/10 (0.00%)	1/8 (12.50%)
Pneumonitis ^† 1	0/10 (0.00%)	1/8 (12.50%)
Sore throat ^† 1	0/10 (0.00%)	1/8 (12.50%)
Dyspnea ^† 1	2/10 (20.00%)	0/8 (0.00%)
Hoarseness ^† 1	1/10 (10.00%)	0/8 (0.00%)
Skin and subcutaneous tissue disorders
Rash maculo-papular ^† 1	0/10 (0.00%)	1/8 (12.50%)
Skin/subcutaneous tissue disorders; Other, specify ^† 1	1/10 (10.00%)	1/8 (12.50%)
Dry skin ^† 1	1/10 (10.00%)	0/8 (0.00%)
Pruritus ^† 1	1/10 (10.00%)	0/8 (0.00%)
Rash acneiform ^† 1	2/10 (20.00%)	0/8 (0.00%)
Vascular disorders
Hot flashes ^† 1	2/10 (20.00%)	1/8 (12.50%)
Hematoma ^† 1	1/10 (10.00%)	0/8 (0.00%)
Hypertension ^† 1	1/10 (10.00%)	0/8 (0.00%)
1 Term from vocabulary, CTCAE (4.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Jose Pablo Leone, MD
Organization:	Dana-Farber Cancer Institute
Phone:	617-632-3800
EMail:	josep_leone@dfci.harvard.edu

Layout table for additonal information

Responsible Party:	Jose Pablo Leone, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT03289039
Other Study ID Numbers:	17-318
First Submitted:	September 18, 2017
First Posted:	September 20, 2017
Results First Submitted:	November 15, 2022
Results First Posted:	March 21, 2023
Last Update Posted:	February 13, 2024

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