Trial Outcomes & Findings for S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy (NCT NCT01598298)

Last Updated: 2022-12-16

Results Overview

Average joint pain according to the Brief Pain Inventory - Short Form (BPI-SF) average pain score (item #4). This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine".

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

299 participants

Primary outcome timeframe

Weeks 2, 6, 12, and 24; Week 12 reported

Results posted on

2022-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I: Duloxetine Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO	Arm II: Placebo Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91. placebo: Given PO
Overall Study STARTED	150	149
Overall Study Patients Evaluable for Primary Endpoint	127	128
Overall Study Patients Evaluable for Adverse Events	138	141
Overall Study COMPLETED	110	108
Overall Study NOT COMPLETED	40	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I: Duloxetine Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO	Arm II: Placebo Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91. placebo: Given PO
Overall Study Not eligible	5	5
Overall Study Adverse Event	21	19
Overall Study Progression/relapse	0	2
Overall Study Withdrawal by Subject	10	15
Overall Study Other reason (not protocol specified)	4	0

Baseline Characteristics

S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I: Duloxetine n=145 Participants Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO	Arm II: Placebo n=144 Participants Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91. placebo: Given PO	Total n=289 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	60 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	145 Participants n=5 Participants	144 Participants n=7 Participants	289 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	140 Participants n=5 Participants	137 Participants n=7 Participants	277 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	17 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	128 Participants n=5 Participants	120 Participants n=7 Participants	248 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Baseline pain score 4-6	110 Participants n=5 Participants	110 Participants n=7 Participants	220 Participants n=5 Participants
Baseline pain score 7-10	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants
Prior taxane use No	68 Participants n=5 Participants	65 Participants n=7 Participants	133 Participants n=5 Participants
Prior taxane use Yes	77 Participants n=5 Participants	79 Participants n=7 Participants	156 Participants n=5 Participants

PRIMARY outcome

Timeframe: Weeks 2, 6, 12, and 24; Week 12 reported

Population: Patients evaluable for primary endpoint

Outcome measures

Outcome measures
Measure	Arm I: Duloxetine n=127 Participants Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO	Arm II: Placebo n=128 Participants Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91. placebo: Given PO
Average Joint Pain According to BPI-SF	2.9 units on a scale Standard Deviation 2.1	3.5 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Weeks 2, 6, 12, and 24; Week 12 reported

Population: Patients evaluable for primary endpoint

Worst joint pain according to the BPI-SF worst pain score (item #2). This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine".

Outcome measures

Outcome measures
Measure	Arm I: Duloxetine n=127 Participants Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO	Arm II: Placebo n=128 Participants Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91. placebo: Given PO
Worst Joint Pain According to the BPI-SF	4.0 units on a scale Standard Deviation 2.8	4.9 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: Weeks 2, 6, 12, and 24; Week 12 reported

Population: Patients evaluable for primary endpoint

Pain interference according to the BPI-SF: this item has a scale of 0 to 10 with 0 indicating "Does not interfere" and 10 indicating "Completely interferes".

Outcome measures

Outcome measures
Measure	Arm I: Duloxetine n=127 Participants Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO	Arm II: Placebo n=128 Participants Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91. placebo: Given PO
Pain Interference According to the BPI-SF	1.9 units on a scale Standard Deviation 2.2	2.6 units on a scale Standard Deviation 2.1

Adverse Events

Arm II: Placebo

Serious events: 0 serious events

Other events: 83 other events

Deaths: 0 deaths

Arm I: Duloxetine

Serious events: 0 serious events

Other events: 115 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Leukemia Committee Statistician

SWOG Statistics and Data Management Center

Phone: 2066674623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Arm II: Placebo n=141 participants at risk Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91. placebo: Given PO	Arm I: Duloxetine n=138 participants at risk Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO
Ear and labyrinth disorders Vertigo	4.3% 6/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	7.2% 10/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Gastrointestinal disorders Abdominal pain	4.3% 6/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	8.0% 11/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Gastrointestinal disorders Constipation	6.4% 9/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	16.7% 23/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Gastrointestinal disorders Diarrhea	7.1% 10/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	15.2% 21/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Gastrointestinal disorders Dry mouth	14.2% 20/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	27.5% 38/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Gastrointestinal disorders Nausea	8.5% 12/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	34.1% 47/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Gastrointestinal disorders Vomiting	1.4% 2/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	5.1% 7/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
General disorders Fatigue	17.7% 25/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	37.7% 52/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
General disorders Flu like symptoms	0.71% 1/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	8.7% 12/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
General disorders Pain	16.3% 23/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	19.6% 27/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Metabolism and nutrition disorders Anorexia	2.1% 3/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	9.4% 13/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Musculoskeletal and connective tissue disorders Arthralgia	18.4% 26/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	22.5% 31/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	9.2% 13/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	10.9% 15/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Musculoskeletal and connective tissue disorders Myalgia	12.8% 18/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	23.2% 32/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Musculoskeletal and connective tissue disorders Pain in extremity	3.5% 5/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	5.8% 8/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Nervous system disorders Dizziness	3.5% 5/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	14.5% 20/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Nervous system disorders Headache	21.3% 30/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	25.4% 35/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Nervous system disorders Lethargy	0.71% 1/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	6.5% 9/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Nervous system disorders Paresthesia	7.1% 10/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	5.1% 7/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Nervous system disorders Somnolence	2.8% 4/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	10.1% 14/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Nervous system disorders Tremor	0.00% 0/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	8.0% 11/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Psychiatric disorders Agitation	5.0% 7/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	7.2% 10/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Psychiatric disorders Insomnia	8.5% 12/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	15.9% 22/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Respiratory, thoracic and mediastinal disorders Cough	4.3% 6/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	5.8% 8/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.7% 8/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	5.1% 7/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.5% 5/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	9.4% 13/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Vascular disorders Hot flashes	15.6% 22/141 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.	23.9% 33/138 • Up to 24 weeks Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.