Trial Outcomes & Findings for A Phase 3 Comparative Study of TAP-144-SR(6M) in Postoperative and Hormone Therapy-naïve Patients With Premenopausal Breast Cancer (NCT NCT01546649)

Last Updated: 2015-11-26

Results Overview

Comparison of both the treatment groups was done by assessing the suppressive effect on serum E2 concentration maintained at menopausal level (=\<30pg/mL). Suppression rate was calculated as proportion of participants maintained at menopausal level.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

167 participants

Primary outcome timeframe

Week 4 up to Week 48

Results posted on

2015-11-26

Participant Flow

Participants took part in the study at 21 investigative sites in Japan from April 2012 to December 2014.

Participants with a historical diagnosis of premenopausal breast cancer were enrolled in 1 of 2 treatment groups as follows: TAP-144-SR(6M); TAP-144-SR(3M)

Participant milestones

Participant milestones
Measure	TAP-144-SR (6M) TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.	TAP-144-SR (3M) TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
Overall Study STARTED	83	84
Overall Study COMPLETED	75	75
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Reasons for withdrawal
Measure	TAP-144-SR (6M) TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.	TAP-144-SR (3M) TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
Overall Study Adverse Event	4	5
Overall Study Protocol Violation	1	0
Overall Study Lack of Efficacy	1	0
Overall Study Recurrence	1	1
Overall Study Discovery of secondary cancer	0	1
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

A Phase 3 Comparative Study of TAP-144-SR(6M) in Postoperative and Hormone Therapy-naïve Patients With Premenopausal Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAP-144-SR (6M) n=83 Participants TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.	TAP-144-SR (3M) n=84 Participants TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.	Total n=167 Participants Total of all reporting groups
Age, Continuous	44.2 years STANDARD_DEVIATION 4.90 • n=5 Participants	44.0 years STANDARD_DEVIATION 5.18 • n=7 Participants	44.1 years STANDARD_DEVIATION 5.03 • n=5 Participants
Age, Customized Less than (<) 40 years	13 participants n=5 Participants	12 participants n=7 Participants	25 participants n=5 Participants
Age, Customized Greater than equal to (>=) 40 to <45 years	29 participants n=5 Participants	30 participants n=7 Participants	59 participants n=5 Participants
Age, Customized >=45 years	41 participants n=5 Participants	42 participants n=7 Participants	83 participants n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	84 Participants n=7 Participants	167 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Height	159.3 centimeter (cm) STANDARD_DEVIATION 5.11 • n=5 Participants	158.1 centimeter (cm) STANDARD_DEVIATION 5.00 • n=7 Participants	158.7 centimeter (cm) STANDARD_DEVIATION 5.08 • n=5 Participants
Height, Customized <150 cm	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Height, Customized >=150 to <160 cm	40 participants n=5 Participants	53 participants n=7 Participants	93 participants n=5 Participants
Height, Customized >=160 cm	41 participants n=5 Participants	28 participants n=7 Participants	69 participants n=5 Participants
Weight	54.48 kilogram (kg) STANDARD_DEVIATION 7.670 • n=5 Participants	53.57 kilogram (kg) STANDARD_DEVIATION 7.498 • n=7 Participants	54.02 kilogram (kg) STANDARD_DEVIATION 7.574 • n=5 Participants
Weight, Customized <50 kg	25 participants n=5 Participants	29 participants n=7 Participants	54 participants n=5 Participants
Weight, Customized >=50 to <60 kg	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants
Weight, Customized >=60 kg	18 participants n=5 Participants	15 participants n=7 Participants	33 participants n=5 Participants
Body Mass Index (BMI)	21.50 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.042 • n=5 Participants	21.45 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.902 • n=7 Participants	21.48 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.964 • n=5 Participants
BMI, Customized <18.5 kg/m^2	8 participants n=5 Participants	13 participants n=7 Participants	21 participants n=5 Participants
BMI, Customized >=18.5 to <25.0 kg/m^2	63 participants n=5 Participants	61 participants n=7 Participants	124 participants n=5 Participants
BMI, Customized >=25.0 to <30.0 kg/m^2	12 participants n=5 Participants	9 participants n=7 Participants	21 participants n=5 Participants
BMI, Customized >=30.0 kg/m^2	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Surgical procedure, Customized Breast-conserving surgery	53 participants n=5 Participants	58 participants n=7 Participants	111 participants n=5 Participants
Surgical procedure, Customized Mastectomy	30 participants n=5 Participants	26 participants n=7 Participants	56 participants n=5 Participants
Pathological diagnosis, Customized Papillotubular carcinoma	33 participants n=5 Participants	36 participants n=7 Participants	69 participants n=5 Participants
Pathological diagnosis, Customized Solid-tubular carcinoma	7 participants n=5 Participants	4 participants n=7 Participants	11 participants n=5 Participants
Pathological diagnosis, Customized Scirrhous carcinoma	30 participants n=5 Participants	34 participants n=7 Participants	64 participants n=5 Participants
Pathological diagnosis, Customized Mucinous carcinoma	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants
Pathological diagnosis, Customized Invasive lobular carcinoma	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Pathological diagnosis, Customized Tubular adenocarcinoma	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Pathological diagnosis, Customized Invasive micropapillary carcinoma	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Pathological diagnosis, Customized Specified neoplasms (other)	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
TNM classification: clinical tumor stage T, Customized T1	63 participants n=5 Participants	64 participants n=7 Participants	127 participants n=5 Participants
TNM classification: clinical tumor stage T, Customized T2	19 participants n=5 Participants	18 participants n=7 Participants	37 participants n=5 Participants
TNM classification: clinical tumor stage T, Customized T3	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
TNM classification: regional lymph node stage N, Customized N0	78 participants n=5 Participants	81 participants n=7 Participants	159 participants n=5 Participants
TNM classification: regional lymph node stage N, Customized N1	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
TNM classification: M0	83 participants n=5 Participants	84 participants n=7 Participants	167 participants n=5 Participants
TNM staging (Stage), Customized I	61 participants n=5 Participants	61 participants n=7 Participants	122 participants n=5 Participants
TNM staging (Stage), Customized IIA	19 participants n=5 Participants	21 participants n=7 Participants	40 participants n=5 Participants
TNM staging (Stage), Customized IIB	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
TNM staging (Stage), Customized IIIA	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Histopathological tumor size	1.64 cm STANDARD_DEVIATION 1.312 • n=5 Participants	1.55 cm STANDARD_DEVIATION 1.023 • n=7 Participants	1.59 cm STANDARD_DEVIATION 1.173 • n=5 Participants
Histopathological tumor size, Customized Less than equal to (<=) 2.0 cm	65 participants n=5 Participants	66 participants n=7 Participants	131 participants n=5 Participants
Histopathological tumor size, Customized >2.0 cm	18 participants n=5 Participants	18 participants n=7 Participants	36 participants n=5 Participants
Axillary lymph node metastases	0.2 number of metastases STANDARD_DEVIATION 0.46 • n=5 Participants	0.2 number of metastases STANDARD_DEVIATION 0.57 • n=7 Participants	0.2 number of metastases STANDARD_DEVIATION 0.52 • n=5 Participants
Axillary lymph node metastases, Customized Present	15 participants n=5 Participants	14 participants n=7 Participants	29 participants n=5 Participants
Axillary lymph node metastases, Customized Absent	68 participants n=5 Participants	70 participants n=7 Participants	138 participants n=5 Participants
Axillary lymph node metastases, Customized 0	68 participants n=5 Participants	70 participants n=7 Participants	138 participants n=5 Participants
Axillary lymph node metastases, Customized >=1 metastasis to <=3 metastases	15 participants n=5 Participants	14 participants n=7 Participants	29 participants n=5 Participants
Axillary lymph node metastases, Customized >=4 metastases	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Time from surgery or previous postoperative adjuvant therapy to administration of study drug <=28 days	6 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants
Time from surgery or previous postoperative adjuvant therapy to administration of study drug >=29 to <=56 days	42 participants n=5 Participants	43 participants n=7 Participants	85 participants n=5 Participants
Time from surgery or previous postoperative adjuvant therapy to administration of study drug >=57 days	35 participants n=5 Participants	32 participants n=7 Participants	67 participants n=5 Participants
Primary tumor estrogen receptors (ER)/ progesterone receptors (PgR) status, Customized ER -positive / PgR-positive	82 participants n=5 Participants	82 participants n=7 Participants	164 participants n=5 Participants
Primary tumor estrogen receptors (ER)/ progesterone receptors (PgR) status, Customized ER -positive / PgR -negative	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Primary tumor estrogen receptors (ER)/ progesterone receptors (PgR) status, Customized ER -negative / PgR -positive	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Human epidermal growth factor receptor 2 (HER2) (immunohistochemistry [IHC] scoring), Customized 0	37 participants n=5 Participants	33 participants n=7 Participants	70 participants n=5 Participants
Human epidermal growth factor receptor 2 (HER2) (immunohistochemistry [IHC] scoring), Customized 1+	33 participants n=5 Participants	28 participants n=7 Participants	61 participants n=5 Participants
Human epidermal growth factor receptor 2 (HER2) (immunohistochemistry [IHC] scoring), Customized 2+	7 participants n=5 Participants	13 participants n=7 Participants	20 participants n=5 Participants
Human epidermal growth factor receptor 2 (HER2) (immunohistochemistry [IHC] scoring), Customized 3+	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Human epidermal growth factor receptor 2 (HER2) (immunohistochemistry [IHC] scoring), Customized Not performed	6 participants n=5 Participants	10 participants n=7 Participants	16 participants n=5 Participants
HER2 (fluorescent in situ hybridization [FISH] testing), Customized Positive	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
HER2 (fluorescent in situ hybridization [FISH] testing), Customized Negative	13 participants n=5 Participants	23 participants n=7 Participants	36 participants n=5 Participants
HER2 (fluorescent in situ hybridization [FISH] testing), Customized Equivocal	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
HER2 (fluorescent in situ hybridization [FISH] testing), Customized Not performed	70 participants n=5 Participants	61 participants n=7 Participants	131 participants n=5 Participants
The eastern cooperative oncology group performance status (ECOG P.S.), Customized 0	83 participants n=5 Participants	84 participants n=7 Participants	167 participants n=5 Participants
The eastern cooperative oncology group performance status (ECOG P.S.), Customized 1	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Menstruation (before the first dose), Customized Present	82 participants n=5 Participants	81 participants n=7 Participants	163 participants n=5 Participants
Menstruation (before the first dose), Customized Absent	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Time from last menstruation to first dose	17.0 days STANDARD_DEVIATION 13.27 • n=5 Participants	15.9 days STANDARD_DEVIATION 14.28 • n=7 Participants	16.4 days STANDARD_DEVIATION 13.75 • n=5 Participants
Time from last menstruation to first dose, Customized <=28 days	72 participants n=5 Participants	73 participants n=7 Participants	145 participants n=5 Participants
Time from last menstruation to first dose, Customized >=29 to <=56 days	8 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants
Time from last menstruation to first dose, Customized >=57 days	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Time from last menstruation to first dose, Customized Missing	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Serum Estradiol (E2) concentration (pretreatment)	168.0 picogram per milliliter (pg/mL) STANDARD_DEVIATION 162.99 • n=5 Participants	138.2 picogram per milliliter (pg/mL) STANDARD_DEVIATION 125.45 • n=7 Participants	153.0 picogram per milliliter (pg/mL) STANDARD_DEVIATION 145.66 • n=5 Participants
Serum E2 concentration (pretreatment), Customized <=29 pg/mL	7 participants n=5 Participants	11 participants n=7 Participants	18 participants n=5 Participants
Serum E2 concentration (pretreatment), Customized >=30 pg/mL	76 participants n=5 Participants	73 participants n=7 Participants	149 participants n=5 Participants
Radiation, Customized Present	52 participants n=5 Participants	59 participants n=7 Participants	111 participants n=5 Participants
Radiation, Customized Absent	31 participants n=5 Participants	25 participants n=7 Participants	56 participants n=5 Participants
Preoperative and postoperative chemotherapy, Customized Present	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Preoperative and postoperative chemotherapy, Customized Absent	83 participants n=5 Participants	83 participants n=7 Participants	166 participants n=5 Participants
Previous breast cancer (other), Customized Present	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Previous breast cancer (other), Customized Absent	83 participants n=5 Participants	84 participants n=7 Participants	167 participants n=5 Participants
Concomitant osteoporosis medication , Customized Present	6 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants
Concomitant osteoporosis medication , Customized Absent	77 participants n=5 Participants	75 participants n=7 Participants	152 participants n=5 Participants
Smoking Classification, Customized Never Smoked	55 participants n=5 Participants	54 participants n=7 Participants	109 participants n=5 Participants
Smoking Classification, Customized Current Smoker	9 participants n=5 Participants	11 participants n=7 Participants	20 participants n=5 Participants
Smoking Classification, Customized Ex-smoker	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants
Time from surgery or previous postoperative adjuvant therapy to administration of study drug	55.4 days STANDARD_DEVIATION 21.69 • n=5 Participants	51.8 days STANDARD_DEVIATION 16.01 • n=7 Participants	53.6 days STANDARD_DEVIATION 19.08 • n=5 Participants

PRIMARY outcome

Timeframe: Week 4 up to Week 48

Population: Full analysis set (FAS) included all randomized participants who had received at least a single dose of study treatment.

Outcome measures

Outcome measures
Measure	TAP-144-SR (6M) n=83 Participants TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.	TAP-144-SR (3M) n=84 Participants TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
Percentage of Participants With Suppressive Effect of Serum Estradiol (E2) to Menopausal Level (=<30 pg/mL) From Week 4 Through Week 48	97.6 percentage of participants Interval 91.565 to 99.707	96.4 percentage of participants Interval 89.916 to 99.257

SECONDARY outcome

Timeframe: Baseline, Hour (hr) 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673

Population: FAS included all randomized participants who had received at least a single dose of study treatment. Here 'N' represents evaluable baseline and post-baseline assessment population.

The measure indicates serum E2 concentration at baseline and post-baseline time points.

Outcome measures

Outcome measures
Measure	TAP-144-SR (6M) n=83 Participants TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.	TAP-144-SR (3M) n=84 Participants TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
Concentration of Serum E2 Day2 [N=83;84]	146.0 pg/mL Interval 0.0 to 693.0	115.5 pg/mL Interval 0.0 to 333.0
Concentration of Serum E2 Day3 [N=83;84]	100.0 pg/mL Interval 0.0 to 417.0	87.5 pg/mL Interval 0.0 to 311.0
Concentration of Serum E2 Week 1 (Day8) [N=83;84]	56.0 pg/mL Interval 0.0 to 904.0	112.0 pg/mL Interval 0.0 to 981.0
Concentration of Serum E2 Week 2 (Day15) [N=83;84]	13.0 pg/mL Interval 0.0 to 866.0	0.0 pg/mL Interval 0.0 to 1220.0
Concentration of Serum E2 Week 3 (Day22) [N=83;84]	0.0 pg/mL Interval 0.0 to 196.0	0.0 pg/mL Interval 0.0 to 722.0
Concentration of Serum E2 Week 4 (Day29) [N=83;84]	0.0 pg/mL Interval 0.0 to 14.0	0.0 pg/mL Interval 0.0 to 50.0
Concentration of Serum E2 Week 8 (Day57) [N=83;84]	0.0 pg/mL Interval 0.0 to 12.0	0.0 pg/mL Interval 0.0 to 158.0
Concentration of Serum E2 Week 12 (Day85) [N=83;83]	0.0 pg/mL Interval 0.0 to 12.0	0.0 pg/mL Interval 0.0 to 11.0
Concentration of Serum E2 Week 16 (Day113) [N=82;82]	0.0 pg/mL Interval 0.0 to 69.0	0.0 pg/mL Interval 0.0 to 16.0
Concentration of Serum E2 Baseline [N=83;84]	95 pg/mL Interval 0.0 to 652.0	99 pg/mL Interval 0.0 to 533.0
Concentration of Serum E2 Day1 (1hr) [N=82;84]	94.5 pg/mL Interval 0.0 to 616.0	110.5 pg/mL Interval 0.0 to 518.0
Concentration of Serum E2 Day1 (3hr) [N=24;21]	102.0 pg/mL Interval 0.0 to 602.0	64.0 pg/mL Interval 15.0 to 404.0
Concentration of Serum E2 Day1 (6hr) [N=24;21]	153.5 pg/mL Interval 0.0 to 681.0	99.0 pg/mL Interval 16.0 to 533.0
Concentration of Serum E2 Day4 [N=83;84]	108.0 pg/mL Interval 0.0 to 543.0	110.0 pg/mL Interval 0.0 to 453.0
Concentration of Serum E2 Week 20 (Day141) [N=81;82]	0.0 pg/mL Interval 0.0 to 15.0	0.0 pg/mL Interval 0.0 to 15.0
Concentration of Serum E2 Week 24 (Day169) [N=80;81]	0.0 pg/mL Interval 0.0 to 27.0	0.0 pg/mL Interval 0.0 to 20.0
Concentration of Serum E2 Week 25 (Day176) [N=79;80]	0.0 pg/mL Interval 0.0 to 18.0	0.0 pg/mL Interval 0.0 to 15.0
Concentration of Serum E2 Week 26 (Day183) [N=79;80]	0.0 pg/mL Interval 0.0 to 14.0	0.0 pg/mL Interval 0.0 to 19.0
Concentration of Serum E2 Week 28 (Day197) [N=75;77]	0.0 pg/mL Interval 0.0 to 14.0	0.0 pg/mL Interval 0.0 to 16.0
Concentration of Serum E2 Week 32 (Day225) [N=78;80]	0.0 pg/mL Interval 0.0 to 17.0	0.0 pg/mL Interval 0.0 to 18.0
Concentration of Serum E2 Week 36 (Day253) [N=79;80]	0.0 pg/mL Interval 0.0 to 18.0	0.0 pg/mL Interval 0.0 to 17.0
Concentration of Serum E2 Week 40 (Day281) [N=78;80]	0.0 pg/mL Interval 0.0 to 184.0	0.0 pg/mL Interval 0.0 to 12.0
Concentration of Serum E2 Week 44 (Day309) [N=77;80]	0.0 pg/mL Interval 0.0 to 16.0	0.0 pg/mL Interval 0.0 to 15.0
Concentration of Serum E2 Week 48 (Day337) [N=77;80]	0.0 pg/mL Interval 0.0 to 15.0	0.0 pg/mL Interval 0.0 to 19.0
Concentration of Serum E2 Week 60 (Day421) [N=77;79]	0.0 pg/mL Interval 0.0 to 25.0	0.0 pg/mL Interval 0.0 to 21.0
Concentration of Serum E2 Week 72 (Day505) [N=77;78]	0.0 pg/mL Interval 0.0 to 14.0	0.0 pg/mL Interval 0.0 to 18.0
Concentration of Serum E2 Week 84 (Day589) [N=76;77]	0.0 pg/mL Interval 0.0 to 15.0	0.0 pg/mL Interval 0.0 to 14.0
Concentration of Serum E2 Week 96 (Day673) [N=75;75]	0.0 pg/mL Interval 0.0 to 12.0	0.0 pg/mL Interval 0.0 to 24.0

SECONDARY outcome

Timeframe: Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673

Population: FAS included all randomized participants who had received at least a single dose of study treatment. Here 'N' represents evaluable baseline and post-baseline assessment population.

This measure indicates serum LH concentration at baseline and post-baseline time points. It was measured in milli-international units per milliliter (mIU/mL).

Outcome measures

Outcome measures
Measure	TAP-144-SR (6M) n=83 Participants TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.	TAP-144-SR (3M) n=84 Participants TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
Concentration of Serum Luteinizing Hormone (LH) Baseline [N=83;84]	4.250 mIU/mL Interval 0.69 to 65.33	4.490 mIU/mL Interval 0.77 to 40.17
Concentration of Serum Luteinizing Hormone (LH) Day1 (1hr) [N=82;84]	27.730 mIU/mL Interval 8.12 to 250.0	30.585 mIU/mL Interval 2.78 to 207.3
Concentration of Serum Luteinizing Hormone (LH) Day3 [N=83;84]	7.310 mIU/mL Interval 1.28 to 27.86	10.500 mIU/mL Interval 1.73 to 59.52
Concentration of Serum Luteinizing Hormone (LH) Day4 [N=83;84]	5.830 mIU/mL Interval 1.13 to 41.16	9.375 mIU/mL Interval 1.63 to 56.11
Concentration of Serum Luteinizing Hormone (LH) Week 20 (Day141) [N=81;82]	0.240 mIU/mL Interval 0.0 to 2.26	0.405 mIU/mL Interval 0.0 to 2.93
Concentration of Serum Luteinizing Hormone (LH) Week 24 (Day169) [N=80;81]	0.290 mIU/mL Interval 0.0 to 8.01	0.460 mIU/mL Interval 0.11 to 2.96
Concentration of Serum Luteinizing Hormone (LH) Week 25 (Day176) [N=79;80]	0.450 mIU/mL Interval 0.0 to 7.92	0.455 mIU/mL Interval 0.15 to 1.47
Concentration of Serum Luteinizing Hormone (LH) Week 26 (Day183) [N=79;80]	0.410 mIU/mL Interval 0.12 to 2.46	0.405 mIU/mL Interval 0.14 to 1.7
Concentration of Serum Luteinizing Hormone (LH) Week 28 (Day197) [N=75;77]	0.270 mIU/mL Interval 0.11 to 0.95	0.410 mIU/mL Interval 0.11 to 1.68
Concentration of Serum Luteinizing Hormone (LH) Week 32 (Day225) [N=78;80]	0.280 mIU/mL Interval 0.0 to 1.31	0.440 mIU/mL Interval 0.14 to 2.45
Concentration of Serum Luteinizing Hormone (LH) Week 36 (Day253) [N=79;80]	0.250 mIU/mL Interval 0.0 to 2.02	0.395 mIU/mL Interval 0.11 to 2.01
Concentration of Serum Luteinizing Hormone (LH) Week 40 (Day281) [N=78;80]	0.240 mIU/mL Interval 0.0 to 2.05	0.390 mIU/mL Interval 0.12 to 1.75
Concentration of Serum Luteinizing Hormone (LH) Week 44 (Day309) [N=77;80]	0.250 mIU/mL Interval 0.0 to 2.67	0.385 mIU/mL Interval 0.0 to 2.14
Concentration of Serum Luteinizing Hormone (LH) Day1 (3hr) [N=24;21]	88.020 mIU/mL Interval 24.64 to 250.0	63.260 mIU/mL Interval 12.0 to 153.6
Concentration of Serum Luteinizing Hormone (LH) Day1 (6hr) [N=24;21]	64.750 mIU/mL Interval 32.54 to 198.9	61.210 mIU/mL Interval 12.68 to 106.1
Concentration of Serum Luteinizing Hormone (LH) Day2 [N=83;84]	14.990 mIU/mL Interval 3.22 to 90.63	19.755 mIU/mL Interval 1.84 to 154.3
Concentration of Serum Luteinizing Hormone (LH) Week 1 (Day8) [N=83;84]	3.190 mIU/mL Interval 0.75 to 25.08	4.475 mIU/mL Interval 1.18 to 29.68
Concentration of Serum Luteinizing Hormone (LH) Week 2 (Day15) [N=83;84]	2.460 mIU/mL Interval 0.76 to 10.56	1.990 mIU/mL Interval 0.75 to 9.65
Concentration of Serum Luteinizing Hormone (LH) Week 3 (Day22) [N=83;84]	1.020 mIU/mL Interval 0.24 to 4.39	1.085 mIU/mL Interval 0.38 to 5.35
Concentration of Serum Luteinizing Hormone (LH) Week 4 (Day29) [N=83;84]	0.540 mIU/mL Interval 0.16 to 1.85	0.845 mIU/mL Interval 0.33 to 2.73
Concentration of Serum Luteinizing Hormone (LH) Week 8 (Day57) [N=83;84]	0.270 mIU/mL Interval 0.0 to 1.15	0.570 mIU/mL Interval 0.0 to 5.17
Concentration of Serum Luteinizing Hormone (LH) Week 12 (Day85) [N=83;83]	0.220 mIU/mL Interval 0.0 to 1.84	0.520 mIU/mL Interval 0.0 to 2.7
Concentration of Serum Luteinizing Hormone (LH) Week 16 (Day113) [N=82;82]	0.245 mIU/mL Interval 0.0 to 7.08	0.430 mIU/mL Interval 0.0 to 1.42
Concentration of Serum Luteinizing Hormone (LH) Week 48 (Day337) [N=77;80]	0.250 mIU/mL Interval 0.0 to 2.12	0.415 mIU/mL Interval 0.11 to 1.3
Concentration of Serum Luteinizing Hormone (LH) Week 60 (Day421) [N=77;79]	0.250 mIU/mL Interval 0.0 to 1.52	0.440 mIU/mL Interval 0.0 to 2.57
Concentration of Serum Luteinizing Hormone (LH) Week 72 (Day505) [N=77;78]	0.260 mIU/mL Interval 0.0 to 1.24	0.420 mIU/mL Interval 0.0 to 1.91
Concentration of Serum Luteinizing Hormone (LH) Week 84 (Day589) [N=76;77]	0.230 mIU/mL Interval 0.0 to 1.3	0.410 mIU/mL Interval 0.0 to 1.34
Concentration of Serum Luteinizing Hormone (LH) Week 96 (Day673) [N=75;75]	0.210 mIU/mL Interval 0.0 to 1.48	0.360 mIU/mL Interval 0.0 to 1.63

SECONDARY outcome

Timeframe: Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673

Population: FAS included all randomized participants who had received at least a single dose of study treatment. Here 'N' represents evaluable baseline and post-baseline assessment population.

This measure indicates serum FSH concentration at baseline and post-baseline time points.

Outcome measures

Outcome measures
Measure	TAP-144-SR (6M) n=83 Participants TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.	TAP-144-SR (3M) n=84 Participants TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
Concentration of Follicle Stimulating Hormone (FSH) Day1 (6hr) [N=24;21]	27.460 mIU/mL Interval 11.19 to 147.78	25.340 mIU/mL Interval 10.85 to 107.69
Concentration of Follicle Stimulating Hormone (FSH) Day2 [N=83;84]	10.080 mIU/mL Interval 2.78 to 93.7	12.515 mIU/mL Interval 3.23 to 115.42
Concentration of Follicle Stimulating Hormone (FSH) Week 3 (Day22) [N=83;84]	1.220 mIU/mL Interval 0.49 to 3.22	1.570 mIU/mL Interval 0.49 to 4.68
Concentration of Follicle Stimulating Hormone (FSH) Week 4 (Day29) [N=83;84]	1.200 mIU/mL Interval 0.39 to 2.48	2.015 mIU/mL Interval 0.68 to 7.37
Concentration of Follicle Stimulating Hormone (FSH) Week 24 (Day169) [N=80;81]	2.060 mIU/mL Interval 0.42 to 6.24	2.000 mIU/mL Interval 0.59 to 6.52
Concentration of Follicle Stimulating Hormone (FSH) Week 25 (Day176) [N=79;80]	1.940 mIU/mL Interval 0.71 to 5.22	1.600 mIU/mL Interval 0.51 to 4.25
Concentration of Follicle Stimulating Hormone (FSH) Baseline [N=83;84]	5.070 mIU/mL Interval 1.97 to 57.33	5.605 mIU/mL Interval 2.03 to 66.13
Concentration of Follicle Stimulating Hormone (FSH) Day1 (1hr) [N=82;84]	9.520 mIU/mL Interval 4.01 to 102.42	10.000 mIU/mL Interval 4.02 to 99.71
Concentration of Follicle Stimulating Hormone (FSH) Day1 (3hr) [N=24;21]	23.325 mIU/mL Interval 8.39 to 110.28	19.950 mIU/mL Interval 10.06 to 74.66
Concentration of Follicle Stimulating Hormone (FSH) Day3 [N=83;84]	6.180 mIU/mL Interval 2.86 to 45.56	6.780 mIU/mL Interval 3.09 to 55.25
Concentration of Follicle Stimulating Hormone (FSH) Day4 [N=83;84]	6.100 mIU/mL Interval 2.84 to 37.79	5.585 mIU/mL Interval 2.75 to 36.28
Concentration of Follicle Stimulating Hormone (FSH) Week 1 (Day8) [N=83;84]	3.920 mIU/mL Interval 0.99 to 14.09	3.035 mIU/mL Interval 1.19 to 11.62
Concentration of Follicle Stimulating Hormone (FSH) Week 2 (Day15) [N=83;84]	1.820 mIU/mL Interval 0.58 to 7.49	1.705 mIU/mL Interval 0.47 to 4.63
Concentration of Follicle Stimulating Hormone (FSH) Week 8 (Day57) [N=83;84]	1.390 mIU/mL Interval 0.36 to 5.15	2.345 mIU/mL Interval 0.87 to 7.75
Concentration of Follicle Stimulating Hormone (FSH) Week 12 (Day85) [N=83;83]	1.490 mIU/mL Interval 0.37 to 5.72	2.240 mIU/mL Interval 0.76 to 7.06
Concentration of Follicle Stimulating Hormone (FSH) Week 16 (Day113) [N=82;82]	1.635 mIU/mL Interval 0.59 to 11.04	1.830 mIU/mL Interval 0.69 to 4.82
Concentration of Follicle Stimulating Hormone (FSH) Week 20 (Day141) [N=81;82]	1.780 mIU/mL Interval 0.53 to 7.28	1.905 mIU/mL Interval 0.87 to 8.76
Concentration of Follicle Stimulating Hormone (FSH) Week 26 (Day183) [N=79;80]	1.560 mIU/mL Interval 0.53 to 3.4	1.700 mIU/mL Interval 0.64 to 3.71
Concentration of Follicle Stimulating Hormone (FSH) Week 28 (Day197) [N=75;77]	1.310 mIU/mL Interval 0.52 to 2.81	1.690 mIU/mL Interval 0.59 to 5.91
Concentration of Follicle Stimulating Hormone (FSH) Week 32 (Day225) [N=78;80]	1.595 mIU/mL Interval 0.52 to 4.81	1.980 mIU/mL Interval 0.57 to 4.69
Concentration of Follicle Stimulating Hormone (FSH) Week 36 (Day253) [N=79;80]	1.660 mIU/mL Interval 0.73 to 6.12	2.035 mIU/mL Interval 0.67 to 5.49
Concentration of Follicle Stimulating Hormone (FSH) Week 40 (Day281) [N=78;80]	1.735 mIU/mL Interval 0.75 to 4.09	1.710 mIU/mL Interval 0.71 to 7.62
Concentration of Follicle Stimulating Hormone (FSH) Week 44 (Day309) [N=77;80]	1.930 mIU/mL Interval 0.72 to 5.01	1.825 mIU/mL Interval 0.7 to 6.39
Concentration of Follicle Stimulating Hormone (FSH) Week 48 (Day337) [N=77;80]	1.920 mIU/mL Interval 0.69 to 8.37	1.885 mIU/mL Interval 0.72 to 4.09
Concentration of Follicle Stimulating Hormone (FSH) Week 60 (Day421) [N=77;79]	1.530 mIU/mL Interval 0.74 to 4.71	1.910 mIU/mL Interval 0.64 to 4.75
Concentration of Follicle Stimulating Hormone (FSH) Week 72 (Day505) [N=77;78]	1.730 mIU/mL Interval 0.92 to 5.89	1.920 mIU/mL Interval 0.63 to 4.3
Concentration of Follicle Stimulating Hormone (FSH) Week 84 (Day589) [N=76;77]	1.500 mIU/mL Interval 0.77 to 3.23	1.840 mIU/mL Interval 0.66 to 3.74
Concentration of Follicle Stimulating Hormone (FSH) Week 96 (Day673) [N=75;75]	1.620 mIU/mL Interval 0.76 to 4.57	1.740 mIU/mL Interval 0.59 to 7.01

SECONDARY outcome

Timeframe: Week 96

Population: FAS included all randomized participants who had received at least a single dose of study treatment.

DFS is defined as time from randomization to earliest day of onset the events, recurrence \[including recurrence in the ipsilateral breast\], secondary cancer \[including breast cancer in the contralateral breast\] and death. DFS at Week 96 was defined as the percentage, calculated with Kaplan-Meier method, of participants did not experience any events at Week 96 since the randomization.

Outcome measures

Outcome measures
Measure	TAP-144-SR (6M) n=83 Participants TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.	TAP-144-SR (3M) n=84 Participants TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
Disease Free Survival (DFS) Rate at Week 96	97.3 percentage of participants	97.5 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: FAS included all randomized participants who had received at least a single dose of study treatment.

DDFS is defined as time from randomization to earliest day of onset the events, distant recurrence, secondary cancer \[including breast cancer in the contralateral breast\] and death. DDFS at week 96 was defined as the percentage calculated with Kaplan-Meier method, of participants did not experience any events at week 96 since the randomization.

Outcome measures

Outcome measures
Measure	TAP-144-SR (6M) n=83 Participants TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.	TAP-144-SR (3M) n=84 Participants TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
Distant Disease Free Survival (DDFS) Rate at Week 96	98.5 percentage of participants	98.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309 and 337

Population: FAS included all randomized participants who had received at least a single dose of study treatment. Here 'N' represents evaluable baseline and post-baseline assessment population.

This measure indicates the unchanged TAP-144 level in serum.

Outcome measures

Outcome measures
Measure	TAP-144-SR (6M) n=83 Participants TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.	TAP-144-SR (3M) n=84 Participants TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
Serum Unchanged TAP-144 Level Day1 (1hr) [N=82;84]	5.293 nanogram per deciliter (ng/dL) Standard Deviation 1.0684 • Interval 8.12 to 250.0	28.45 nanogram per deciliter (ng/dL) Standard Deviation 9.7398 • Interval 2.78 to 207.3
Serum Unchanged TAP-144 Level Day1 (3hr) [N=24;19]	2.538 nanogram per deciliter (ng/dL) Standard Deviation 0.46023 • Interval 24.64 to 250.0	20.27 nanogram per deciliter (ng/dL) Standard Deviation 3.9535 • Interval 12.0 to 153.6
Serum Unchanged TAP-144 Level Day1 (6hr) [N=24;21]	1.039 nanogram per deciliter (ng/dL) Standard Deviation 0.23264 • Interval 32.54 to 198.9	8.037 nanogram per deciliter (ng/dL) Standard Deviation 1.7408 • Interval 12.68 to 106.1
Serum Unchanged TAP-144 Level Day2 [N=83;84]	0.1401 nanogram per deciliter (ng/dL) Standard Deviation 0.066137 • Interval 3.22 to 90.63	0.4749 nanogram per deciliter (ng/dL) Standard Deviation 0.17801 • Interval 1.84 to 154.3
Serum Unchanged TAP-144 Level Week 4 (Day29) [N=83;83]	0.3442 nanogram per deciliter (ng/dL) Standard Deviation 0.19814 • Interval 0.16 to 1.85	0.04971 nanogram per deciliter (ng/dL) Standard Deviation 0.032917 • Interval 0.33 to 2.73
Serum Unchanged TAP-144 Level Week 8 (Day57) [N=83;83]	0.1146 nanogram per deciliter (ng/dL) Standard Deviation 0.053068 • Interval 0.0 to 1.15	0.04744 nanogram per deciliter (ng/dL) Standard Deviation 0.032379 • Interval 0.0 to 5.17
Serum Unchanged TAP-144 Level Week 12 (Day85) [N=83;83]	0.08051 nanogram per deciliter (ng/dL) Standard Deviation 0.041881 • Interval 0.0 to 1.84	0.06028 nanogram per deciliter (ng/dL) Standard Deviation 0.031104 • Interval 0.0 to 2.7
Serum Unchanged TAP-144 Level Week 16 (Day113) [N=82;82]	0.05775 nanogram per deciliter (ng/dL) Standard Deviation 0.037098 • Interval 0.0 to 7.08	0.09347 nanogram per deciliter (ng/dL) Standard Deviation 0.077284 • Interval 0.0 to 1.42
Serum Unchanged TAP-144 Level Week 20 (Day141) [N=81;82]	0.03941 nanogram per deciliter (ng/dL) Standard Deviation 0.037082 • Interval 0.0 to 2.26	0.07165 nanogram per deciliter (ng/dL) Standard Deviation 0.062739 • Interval 0.0 to 2.93
Serum Unchanged TAP-144 Level Week 24 (Day169) [N=80;81]	0.02931 nanogram per deciliter (ng/dL) Standard Deviation 0.019785 • Interval 0.0 to 8.01	0.07634 nanogram per deciliter (ng/dL) Standard Deviation 0.064118 • Interval 0.11 to 2.96
Serum Unchanged TAP-144 Level Baseline [N=83;84]	0.000 nanogram per deciliter (ng/dL) Standard Deviation 0.0000 • Interval 0.69 to 65.33	0.000 nanogram per deciliter (ng/dL) Standard Deviation 0.0000 • Interval 0.77 to 40.17
Serum Unchanged TAP-144 Level Day3 [N=83;84]	0.02889 nanogram per deciliter (ng/dL) Standard Deviation 0.026108 • Interval 1.28 to 27.86	0.2492 nanogram per deciliter (ng/dL) Standard Deviation 0.097054 • Interval 1.73 to 59.52
Serum Unchanged TAP-144 Level Day4 [N=83;84]	0.02380 nanogram per deciliter (ng/dL) Standard Deviation 0.022645 • Interval 1.13 to 41.16	0.2273 nanogram per deciliter (ng/dL) Standard Deviation 0.080794 • Interval 1.63 to 56.11
Serum Unchanged TAP-144 Level Week 1 (Day8) [N=82;83]	0.09115 nanogram per deciliter (ng/dL) Standard Deviation 0.22637 • Interval 0.75 to 25.08	0.1050 nanogram per deciliter (ng/dL) Standard Deviation 0.049062 • Interval 1.18 to 29.68
Serum Unchanged TAP-144 Level Week 2 (Day15) [N=82;84]	0.3702 nanogram per deciliter (ng/dL) Standard Deviation 0.25134 • Interval 0.76 to 10.56	0.08867 nanogram per deciliter (ng/dL) Standard Deviation 0.077142 • Interval 0.75 to 9.65
Serum Unchanged TAP-144 Level Week 3 (Day22) [N=83;84]	0.7285 nanogram per deciliter (ng/dL) Standard Deviation 0.35639 • Interval 0.24 to 4.39	0.06471 nanogram per deciliter (ng/dL) Standard Deviation 0.092279 • Interval 0.38 to 5.35
Serum Unchanged TAP-144 Level Week 25 (Day176) [N=79;80]	0.1128 nanogram per deciliter (ng/dL) Standard Deviation 0.16751 • Interval 0.0 to 7.92	0.1583 nanogram per deciliter (ng/dL) Standard Deviation 0.089299 • Interval 0.15 to 1.47
Serum Unchanged TAP-144 Level Week 26 (Day183) [N=79;80]	0.3327 nanogram per deciliter (ng/dL) Standard Deviation 0.36474 • Interval 0.12 to 2.46	0.1109 nanogram per deciliter (ng/dL) Standard Deviation 0.065133 • Interval 0.14 to 1.7
Serum Unchanged TAP-144 Level Week 28 (Day197) [N=80;80]	0.4687 nanogram per deciliter (ng/dL) Standard Deviation 0.36083 • Interval 0.11 to 0.95	0.08468 nanogram per deciliter (ng/dL) Standard Deviation 0.040820 • Interval 0.11 to 1.68
Serum Unchanged TAP-144 Level Week 32 (Day225) [N=78;80]	0.1377 nanogram per deciliter (ng/dL) Standard Deviation 0.093340 • Interval 0.0 to 1.31	0.06881 nanogram per deciliter (ng/dL) Standard Deviation 0.037607 • Interval 0.14 to 2.45
Serum Unchanged TAP-144 Level Week 36 (Day253) [N=79;80]	0.08521 nanogram per deciliter (ng/dL) Standard Deviation 0.040324 • Interval 0.0 to 2.02	0.06259 nanogram per deciliter (ng/dL) Standard Deviation 0.036687 • Interval 0.11 to 2.01
Serum Unchanged TAP-144 Level Week 40 (Day281) [N=79;80]	0.06073 nanogram per deciliter (ng/dL) Standard Deviation 0.032232 • Interval 0.0 to 2.05	0.08163 nanogram per deciliter (ng/dL) Standard Deviation 0.031631 • Interval 0.12 to 1.75
Serum Unchanged TAP-144 Level Week 44 (Day309) [N=77;80]	0.4339 nanogram per deciliter (ng/dL) Standard Deviation 0.026552 • Interval 0.0 to 2.67	0.06479 nanogram per deciliter (ng/dL) Standard Deviation 0.028540 • Interval 0.0 to 2.14
Serum Unchanged TAP-144 Level Week 48 (Day337) [N=77;80]	0.02957 nanogram per deciliter (ng/dL) Standard Deviation 0.017147 • Interval 0.0 to 2.12	0.06313 nanogram per deciliter (ng/dL) Standard Deviation 0.032149 • Interval 0.11 to 1.3

SECONDARY outcome

Timeframe: Baseline, Hour 1, 3, 6 on Day 1, Day 29, 85, 169 and 337

Population: Safety evaluation was conducted in the safety analysis set (SAS). Here 'N' represents evaluable baseline and post-baseline assessment population.

12-lead electrocardiography measurement was performed in supine position after 5 minutes at rest. Each measurement was recorded continuously for 10 seconds at the recording speed of 25 millimeter/second (mm/second).

Outcome measures

Outcome measures
Measure	TAP-144-SR (6M) n=83 Participants TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.	TAP-144-SR (3M) n=84 Participants TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
QT Interval Measured by 12-lead Electrocardiogram (ECG) Day1 (6hr) [N=24;21]	415.8 millisecond (msec) Standard Deviation 18.68 • Interval 32.54 to 198.9	424.1 millisecond (msec) Standard Deviation 13.76 • Interval 12.68 to 106.1
QT Interval Measured by 12-lead Electrocardiogram (ECG) Week 4 (Day29) [N=83;84]	431.2 millisecond (msec) Standard Deviation 19.30 • Interval 0.16 to 1.85	432.3 millisecond (msec) Standard Deviation 16.90 • Interval 0.33 to 2.73
QT Interval Measured by 12-lead Electrocardiogram (ECG) Week 12 (Day85) [N=83;84]	433.3 millisecond (msec) Standard Deviation 19.44 • Interval 0.0 to 1.84	432.3 millisecond (msec) Standard Deviation 20.01 • Interval 0.0 to 2.7
QT Interval Measured by 12-lead Electrocardiogram (ECG) Week 24 (Day169) [N=81;82]	431.0 millisecond (msec) Standard Deviation 21.22 • Interval 0.0 to 8.01	429.0 millisecond (msec) Standard Deviation 20.28 • Interval 0.11 to 2.96
QT Interval Measured by 12-lead Electrocardiogram (ECG) Week 48 (Day337) [N=77;80]	430.0 millisecond (msec) Standard Deviation 17.31 • Interval 0.0 to 2.12	431.4 millisecond (msec) Standard Deviation 18.89 • Interval 0.11 to 1.3
QT Interval Measured by 12-lead Electrocardiogram (ECG) Baseline [N=83;84]	421.5 millisecond (msec) Standard Deviation 16.05 • Interval 0.69 to 65.33	420.9 millisecond (msec) Standard Deviation 16.53 • Interval 0.77 to 40.17
QT Interval Measured by 12-lead Electrocardiogram (ECG) Day1 (1hr) [N=83;84]	417.8 millisecond (msec) Standard Deviation 15.37 • Interval 8.12 to 250.0	417.1 millisecond (msec) Standard Deviation 17.83 • Interval 2.78 to 207.3
QT Interval Measured by 12-lead Electrocardiogram (ECG) Day1 (3hr) [N=24;21]	416.8 millisecond (msec) Standard Deviation 11.34 • Interval 24.64 to 250.0	423.7 millisecond (msec) Standard Deviation 18.90 • Interval 12.0 to 153.6

Adverse Events

TAP-144-SR (6M)

Serious events: 6 serious events

Other events: 82 other events

Deaths: 0 deaths

TAP-144-SR (3M)

Serious events: 7 serious events

Other events: 82 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TAP-144-SR (6M) n=83 participants at risk TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.	TAP-144-SR (3M) n=84 participants at risk TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
Eye disorders Eyelid ptosis	1.2% 1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/84 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Anal fistula	1.2% 1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/84 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Hepatobiliary disorders Cholelithiasis	0.00% 0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.2% 1/84 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Gastroenteritis	1.2% 1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/84 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Infectious mononucleosis	1.2% 1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/84 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Sinusitis	0.00% 0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.2% 1/84 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Occult blood positive	0.00% 0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.2% 1/84 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.2% 1/84 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage 0	0.00% 0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.2% 1/84 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Multiple sclerosis	1.2% 1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/84 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders VIIth nerve paralysis	1.2% 1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/84 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.2% 1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.2% 1/84 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.2% 1/84 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Behcet's syndrome	0.00% 0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.2% 1/84 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER