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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01546649

Enrollment

167

Registered

2012-03-07

Start date

2012-04-30

Completion date

2014-12-31

Last updated

2015-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premenopausal Breast Cancer

Brief summary

Hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) will be evaluated against TAP-144-SR(3M) in postoperative and hormone therapy-naïve patients with premenopausal breast cancer

Interventions

DRUGTAP-144-SR(6M)

DRUGTAP-144-SR(3M)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

1. The participant has histopathologically-confirmed primary breast cancer in Japanese. 2. The participant is aged 20 years or older when informed consent is obtained 3. The participant has estrogen receptor (ER)-positive tumor cells and/or progesterone receptor (PgR)-positive primary tumor. And HER-2 is negative. 4. The participant has breast cancer in the clinical stages of T1-T3, N-any and M0 by TNM classification (the seventh edition, proposed by UICC in 2009). (No distant metastasis to lung, liver and bone should be confirmed on the image-based diagnosis at study enrollment. The image taken within 12 weeks prior to study enrollment is also available for the diagnosis.) The number of axillary lymph node metastasis is not limited. 5. Any operative procedure for breast cancer is acceptable. In principle, after breast-conserving surgery, the participant will receive postoperative radiation to the conserving breast. 6. Neoadjuvant chemotherapy and adjuvant chemotherapy prior to study enrollment are acceptable. (It is advisable the same kind of chemotherapy is performed at each site.) 7. The participant has a history of regular menstrual periods within 12 weeks prior to study enrollment, or the participant has FSH of less than 40 mIU/mL and E2 of 10 pg/mL or more measured within 12 weeks prior to study enrollment. The participant has not had a chemical menopause (i.e., FSH of less than 40 mIU/mL and E2 of 10 pg/mL or more) within 12 weeks after completing adjuvant chemotherapy. 8. The participant is in a condition to receive study drug and Tamoxifen (TAM) within 12 weeks after surgery or after adjuvant chemotherapy prior to study enrollment. Adjuvant chemotherapy prior to study is required to have been completed at the time of study enrollment. 9. The participant has ECOG performance status of grades 0 or 1 at the time of study enrollment. 10. The participant meets the following criteria of hepatic, renal and bone marrow functions on the laboratory test results at screening: * Hepatic function: AST (GOT) ≤ 3.0 times the upper limit of normal (ULN) ALT (GPT) ≤ 3.0 times the ULN * Renal function: serum creatinine level \< 1.5 times the ULN * Bone marrow function : white blood cell count ≥ 3,000/mm3 platelet count ≥ 100,000/μL hemoglobin ≥ 10.0g/dL 11. The participant agrees to use a non-hormonal method of contraception through the study period.

Exclusion criteria

1. The participant has received neoadjuvant or adjuvant hormonal therapy for the latest breast cancer surgery. 2. The participant has received bilateral oophorectomy and bilateral ovarian irradiation. 3. The participant has inflammatory breast cancer or bilateral breast cancer. 4. The participant has non-invasive ductal carcinoma. 5. The participant has multiple primary cancers, or a history of carcinoma in other organs. 6. The participant is pregnant or breast-feeding. 7. The participant has a history of hypersensitivity to synthetic LH-RH, LH-RH derivative, TAM, TAM analogue (antiestrogen) or any component of the study drug. 8. The participant has a history of, or has been diagnosed with thromboembolism including myocardial infarction, cerebral infarction, venous thrombosis, and pulmonary embolism, or cardiac failure. 9. Patients whose QTcF interval exceeded 460 msec on the 12-lead electrocardiogram at screening.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Suppressive Effect of Serum Estradiol (E2) to Menopausal Level (=<30 pg/mL) From Week 4 Through Week 48	Week 4 up to Week 48	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.

Secondary

Measure	Time frame	Description
Concentration of Serum Luteinizing Hormone (LH)	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	This measure indicates serum LH concentration at baseline and post-baseline time points. It was measured in milli-international units per milliliter (mIU/mL).
Concentration of Follicle Stimulating Hormone (FSH)	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	This measure indicates serum FSH concentration at baseline and post-baseline time points.
Disease Free Survival (DFS) Rate at Week 96	Week 96	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.
Concentration of Serum E2	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	The measure indicates serum E2 concentration at baseline and post-baseline time points.
Serum Unchanged TAP-144 Level	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	This measure indicates the unchanged TAP-144 level in serum.
QT Interval Measured by 12-lead Electrocardiogram (ECG)	Baseline, Hour 1, 3, 6 on Day 1, Day 29, 85, 169 and 337	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).
Distant Disease Free Survival (DDFS) Rate at Week 96	Week 96	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.

Countries

Japan

Participant flow

Recruitment details

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

Pre-assignment details

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)

Participants by arm

Arm	Count
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.	83
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.	84
Total	167

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	4	5
Overall Study	Discovery of secondary cancer	0	1
Overall Study	Lack of Efficacy	1	0
Overall Study	Protocol Violation	1	0
Overall Study	Recurrence	1	1
Overall Study	Withdrawal by Subject	1	2

Baseline characteristics

Characteristic	Total	TAP-144-SR (6M)	TAP-144-SR (3M)
Age, Continuous	44.1 years STANDARD_DEVIATION 5.03	44.2 years STANDARD_DEVIATION 4.9	44.0 years STANDARD_DEVIATION 5.18
Age, Customized >=45 years	83 participants	41 participants	42 participants
Age, Customized Greater than equal to (>=) 40 to <45 years	59 participants	29 participants	30 participants
Age, Customized Less than (<) 40 years	25 participants	13 participants	12 participants
Axillary lymph node metastases	0.2 number of metastases STANDARD_DEVIATION 0.52	0.2 number of metastases STANDARD_DEVIATION 0.46	0.2 number of metastases STANDARD_DEVIATION 0.57
Axillary lymph node metastases, Customized 0	138 participants	68 participants	70 participants
Axillary lymph node metastases, Customized >=1 metastasis to <=3 metastases	29 participants	15 participants	14 participants
Axillary lymph node metastases, Customized >=4 metastases	0 participants	0 participants	0 participants
Axillary lymph node metastases, Customized Absent	138 participants	68 participants	70 participants
Axillary lymph node metastases, Customized Present	29 participants	15 participants	14 participants
BMI, Customized <18.5 kg/m^2	21 participants	8 participants	13 participants
BMI, Customized >=18.5 to <25.0 kg/m^2	124 participants	63 participants	61 participants
BMI, Customized >=25.0 to <30.0 kg/m^2	21 participants	12 participants	9 participants
BMI, Customized >=30.0 kg/m^2	1 participants	0 participants	1 participants
Body Mass Index (BMI)	21.48 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.964	21.50 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.042	21.45 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.902
Concomitant osteoporosis medication , Customized Absent	152 participants	77 participants	75 participants
Concomitant osteoporosis medication , Customized Present	15 participants	6 participants	9 participants
Height	158.7 centimeter (cm) STANDARD_DEVIATION 5.08	159.3 centimeter (cm) STANDARD_DEVIATION 5.11	158.1 centimeter (cm) STANDARD_DEVIATION 5
Height, Customized <150 cm	5 participants	2 participants	3 participants
Height, Customized >=150 to <160 cm	93 participants	40 participants	53 participants
Height, Customized >=160 cm	69 participants	41 participants	28 participants
HER2 (fluorescent in situ hybridization [FISH] testing), Customized Equivocal	0 participants	0 participants	0 participants
HER2 (fluorescent in situ hybridization [FISH] testing), Customized Negative	36 participants	13 participants	23 participants
HER2 (fluorescent in situ hybridization [FISH] testing), Customized Not performed	131 participants	70 participants	61 participants
HER2 (fluorescent in situ hybridization [FISH] testing), Customized Positive	0 participants	0 participants	0 participants
Histopathological tumor size	1.59 cm STANDARD_DEVIATION 1.173	1.64 cm STANDARD_DEVIATION 1.312	1.55 cm STANDARD_DEVIATION 1.023
Histopathological tumor size, Customized >2.0 cm	36 participants	18 participants	18 participants
Histopathological tumor size, Customized Less than equal to (<=) 2.0 cm	131 participants	65 participants	66 participants
Human epidermal growth factor receptor 2 (HER2) (immunohistochemistry [IHC] scoring), Customized 0	70 participants	37 participants	33 participants
Human epidermal growth factor receptor 2 (HER2) (immunohistochemistry [IHC] scoring), Customized 1+	61 participants	33 participants	28 participants
Human epidermal growth factor receptor 2 (HER2) (immunohistochemistry [IHC] scoring), Customized 2+	20 participants	7 participants	13 participants
Human epidermal growth factor receptor 2 (HER2) (immunohistochemistry [IHC] scoring), Customized 3+	0 participants	0 participants	0 participants
Human epidermal growth factor receptor 2 (HER2) (immunohistochemistry [IHC] scoring), Customized Not performed	16 participants	6 participants	10 participants
Menstruation (before the first dose), Customized Absent	4 participants	1 participants	3 participants
Menstruation (before the first dose), Customized Present	163 participants	82 participants	81 participants
Pathological diagnosis, Customized Invasive lobular carcinoma	12 participants	6 participants	6 participants
Pathological diagnosis, Customized Invasive micropapillary carcinoma	4 participants	1 participants	3 participants
Pathological diagnosis, Customized Mucinous carcinoma	5 participants	4 participants	1 participants
Pathological diagnosis, Customized Papillotubular carcinoma	69 participants	33 participants	36 participants
Pathological diagnosis, Customized Scirrhous carcinoma	64 participants	30 participants	34 participants
Pathological diagnosis, Customized Solid-tubular carcinoma	11 participants	7 participants	4 participants
Pathological diagnosis, Customized Specified neoplasms (other)	1 participants	1 participants	0 participants
Pathological diagnosis, Customized Tubular adenocarcinoma	1 participants	1 participants	0 participants
Preoperative and postoperative chemotherapy, Customized Absent	166 participants	83 participants	83 participants
Preoperative and postoperative chemotherapy, Customized Present	1 participants	0 participants	1 participants
Previous breast cancer (other), Customized Absent	167 participants	83 participants	84 participants
Previous breast cancer (other), Customized Present	0 participants	0 participants	0 participants
Primary tumor estrogen receptors (ER)/ progesterone receptors (PgR) status, Customized ER -negative / PgR -positive	0 participants	0 participants	0 participants
Primary tumor estrogen receptors (ER)/ progesterone receptors (PgR) status, Customized ER -positive / PgR -negative	3 participants	1 participants	2 participants
Primary tumor estrogen receptors (ER)/ progesterone receptors (PgR) status, Customized ER -positive / PgR-positive	164 participants	82 participants	82 participants
Radiation, Customized Absent	56 participants	31 participants	25 participants
Radiation, Customized Present	111 participants	52 participants	59 participants
Serum E2 concentration (pretreatment), Customized <=29 pg/mL	18 participants	7 participants	11 participants
Serum E2 concentration (pretreatment), Customized >=30 pg/mL	149 participants	76 participants	73 participants
Serum Estradiol (E2) concentration (pretreatment)	153.0 picogram per milliliter (pg/mL) STANDARD_DEVIATION 145.66	168.0 picogram per milliliter (pg/mL) STANDARD_DEVIATION 162.99	138.2 picogram per milliliter (pg/mL) STANDARD_DEVIATION 125.45
Sex: Female, Male Female	167 Participants	83 Participants	84 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants
Smoking Classification, Customized Current Smoker	20 participants	9 participants	11 participants
Smoking Classification, Customized Ex-smoker	38 participants	19 participants	19 participants
Smoking Classification, Customized Never Smoked	109 participants	55 participants	54 participants
Surgical procedure, Customized Breast-conserving surgery	111 participants	53 participants	58 participants
Surgical procedure, Customized Mastectomy	56 participants	30 participants	26 participants
The eastern cooperative oncology group performance status (ECOG P.S.), Customized 0	167 participants	83 participants	84 participants
The eastern cooperative oncology group performance status (ECOG P.S.), Customized 1	0 participants	0 participants	0 participants
Time from last menstruation to first dose	16.4 days STANDARD_DEVIATION 13.75	17.0 days STANDARD_DEVIATION 13.27	15.9 days STANDARD_DEVIATION 14.28
Time from last menstruation to first dose, Customized <=28 days	145 participants	72 participants	73 participants
Time from last menstruation to first dose, Customized >=29 to <=56 days	14 participants	8 participants	6 participants
Time from last menstruation to first dose, Customized >=57 days	4 participants	2 participants	2 participants
Time from last menstruation to first dose, Customized Missing	4 participants	1 participants	3 participants
Time from surgery or previous postoperative adjuvant therapy to administration of study drug <=28 days	15 participants	6 participants	9 participants
Time from surgery or previous postoperative adjuvant therapy to administration of study drug >=29 to <=56 days	85 participants	42 participants	43 participants
Time from surgery or previous postoperative adjuvant therapy to administration of study drug >=57 days	67 participants	35 participants	32 participants
Time from surgery or previous postoperative adjuvant therapy to administration of study drug	53.6 days STANDARD_DEVIATION 19.08	55.4 days STANDARD_DEVIATION 21.69	51.8 days STANDARD_DEVIATION 16.01
TNM classification: clinical tumor stage T, Customized T1	127 participants	63 participants	64 participants
TNM classification: clinical tumor stage T, Customized T2	37 participants	19 participants	18 participants
TNM classification: clinical tumor stage T, Customized T3	3 participants	1 participants	2 participants
TNM classification: M0	167 participants	83 participants	84 participants
TNM classification: regional lymph node stage N, Customized N0	159 participants	78 participants	81 participants
TNM classification: regional lymph node stage N, Customized N1	8 participants	5 participants	3 participants
TNM staging (Stage), Customized I	122 participants	61 participants	61 participants
TNM staging (Stage), Customized IIA	40 participants	19 participants	21 participants
TNM staging (Stage), Customized IIB	4 participants	2 participants	2 participants
TNM staging (Stage), Customized IIIA	1 participants	1 participants	0 participants
Weight	54.02 kilogram (kg) STANDARD_DEVIATION 7.574	54.48 kilogram (kg) STANDARD_DEVIATION 7.67	53.57 kilogram (kg) STANDARD_DEVIATION 7.498
Weight, Customized <50 kg	54 participants	25 participants	29 participants
Weight, Customized >=50 to <60 kg	80 participants	40 participants	40 participants
Weight, Customized >=60 kg	33 participants	18 participants	15 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	82 / 83	82 / 84
serious Total, serious adverse events	6 / 83	7 / 84

Outcome results

Primary

Percentage of Participants With Suppressive Effect of Serum Estradiol (E2) to Menopausal Level (=<30 pg/mL) From Week 4 Through Week 48

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.

Time frame: 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.

Arm	Measure	Value (NUMBER)
TAP-144-SR (6M)	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
TAP-144-SR (3M)	Percentage of Participants With Suppressive Effect of Serum Estradiol (E2) to Menopausal Level (=<30 pg/mL) From Week 4 Through Week 48	96.4 percentage of participants

Secondary

Concentration of Follicle Stimulating Hormone (FSH)

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

Time frame: 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.

Arm	Measure	Group	Value (MEDIAN)
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 20 (Day141) [N=81;82]	1.780 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Day2 [N=83;84]	10.080 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 24 (Day169) [N=80;81]	2.060 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 2 (Day15) [N=83;84]	1.820 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 25 (Day176) [N=79;80]	1.940 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Day1 (1hr) [N=82;84]	9.520 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 26 (Day183) [N=79;80]	1.560 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 3 (Day22) [N=83;84]	1.220 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 28 (Day197) [N=75;77]	1.310 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Day3 [N=83;84]	6.180 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 32 (Day225) [N=78;80]	1.595 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 4 (Day29) [N=83;84]	1.200 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 36 (Day253) [N=79;80]	1.660 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Day1 (6hr) [N=24;21]	27.460 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 40 (Day281) [N=78;80]	1.735 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 8 (Day57) [N=83;84]	1.390 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 44 (Day309) [N=77;80]	1.930 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Day4 [N=83;84]	6.100 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 48 (Day337) [N=77;80]	1.920 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 12 (Day85) [N=83;83]	1.490 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 60 (Day421) [N=77;79]	1.530 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Day1 (3hr) [N=24;21]	23.325 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 72 (Day505) [N=77;78]	1.730 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 16 (Day113) [N=82;82]	1.635 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 84 (Day589) [N=76;77]	1.500 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 1 (Day8) [N=83;84]	3.920 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 96 (Day673) [N=75;75]	1.620 mIU/mL
TAP-144-SR (6M)	Concentration of Follicle Stimulating Hormone (FSH)	Baseline [N=83;84]	5.070 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 96 (Day673) [N=75;75]	1.740 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Baseline [N=83;84]	5.605 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Day1 (1hr) [N=82;84]	10.000 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Day1 (3hr) [N=24;21]	19.950 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Day1 (6hr) [N=24;21]	25.340 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Day2 [N=83;84]	12.515 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Day3 [N=83;84]	6.780 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Day4 [N=83;84]	5.585 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 1 (Day8) [N=83;84]	3.035 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 2 (Day15) [N=83;84]	1.705 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 3 (Day22) [N=83;84]	1.570 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 4 (Day29) [N=83;84]	2.015 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 8 (Day57) [N=83;84]	2.345 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 12 (Day85) [N=83;83]	2.240 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 16 (Day113) [N=82;82]	1.830 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 20 (Day141) [N=81;82]	1.905 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 24 (Day169) [N=80;81]	2.000 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 25 (Day176) [N=79;80]	1.600 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 26 (Day183) [N=79;80]	1.700 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 28 (Day197) [N=75;77]	1.690 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 32 (Day225) [N=78;80]	1.980 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 36 (Day253) [N=79;80]	2.035 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 40 (Day281) [N=78;80]	1.710 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 44 (Day309) [N=77;80]	1.825 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 48 (Day337) [N=77;80]	1.885 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 60 (Day421) [N=77;79]	1.910 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 72 (Day505) [N=77;78]	1.920 mIU/mL
TAP-144-SR (3M)	Concentration of Follicle Stimulating Hormone (FSH)	Week 84 (Day589) [N=76;77]	1.840 mIU/mL

Secondary

Concentration of Serum E2

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

Time frame: 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.

Arm	Measure	Group	Value (MEDIAN)
TAP-144-SR (6M)	Concentration of Serum E2	Week 20 (Day141) [N=81;82]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Day2 [N=83;84]	146.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 24 (Day169) [N=80;81]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 2 (Day15) [N=83;84]	13.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 25 (Day176) [N=79;80]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Day1 (1hr) [N=82;84]	94.5 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 26 (Day183) [N=79;80]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 3 (Day22) [N=83;84]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 28 (Day197) [N=75;77]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Day3 [N=83;84]	100.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 32 (Day225) [N=78;80]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 4 (Day29) [N=83;84]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 36 (Day253) [N=79;80]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Day1 (6hr) [N=24;21]	153.5 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 40 (Day281) [N=78;80]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 8 (Day57) [N=83;84]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 44 (Day309) [N=77;80]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Day4 [N=83;84]	108.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 48 (Day337) [N=77;80]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 12 (Day85) [N=83;83]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 60 (Day421) [N=77;79]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Day1 (3hr) [N=24;21]	102.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 72 (Day505) [N=77;78]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 16 (Day113) [N=82;82]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 84 (Day589) [N=76;77]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 1 (Day8) [N=83;84]	56.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Week 96 (Day673) [N=75;75]	0.0 pg/mL
TAP-144-SR (6M)	Concentration of Serum E2	Baseline [N=83;84]	95 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 96 (Day673) [N=75;75]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Baseline [N=83;84]	99 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Day1 (1hr) [N=82;84]	110.5 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Day1 (3hr) [N=24;21]	64.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Day1 (6hr) [N=24;21]	99.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Day2 [N=83;84]	115.5 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Day3 [N=83;84]	87.5 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Day4 [N=83;84]	110.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 1 (Day8) [N=83;84]	112.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 2 (Day15) [N=83;84]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 3 (Day22) [N=83;84]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 4 (Day29) [N=83;84]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 8 (Day57) [N=83;84]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 12 (Day85) [N=83;83]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 16 (Day113) [N=82;82]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 20 (Day141) [N=81;82]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 24 (Day169) [N=80;81]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 25 (Day176) [N=79;80]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 26 (Day183) [N=79;80]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 28 (Day197) [N=75;77]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 32 (Day225) [N=78;80]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 36 (Day253) [N=79;80]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 40 (Day281) [N=78;80]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 44 (Day309) [N=77;80]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 48 (Day337) [N=77;80]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 60 (Day421) [N=77;79]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 72 (Day505) [N=77;78]	0.0 pg/mL
TAP-144-SR (3M)	Concentration of Serum E2	Week 84 (Day589) [N=76;77]	0.0 pg/mL

Secondary

Concentration of Serum Luteinizing Hormone (LH)

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

Time frame: 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.

Arm	Measure	Group	Value (MEDIAN)
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 20 (Day141) [N=81;82]	0.240 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Day2 [N=83;84]	14.990 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 24 (Day169) [N=80;81]	0.290 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 2 (Day15) [N=83;84]	2.460 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 25 (Day176) [N=79;80]	0.450 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Day1 (1hr) [N=82;84]	27.730 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 26 (Day183) [N=79;80]	0.410 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 3 (Day22) [N=83;84]	1.020 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 28 (Day197) [N=75;77]	0.270 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Day3 [N=83;84]	7.310 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 32 (Day225) [N=78;80]	0.280 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 4 (Day29) [N=83;84]	0.540 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 36 (Day253) [N=79;80]	0.250 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Day1 (6hr) [N=24;21]	64.750 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 40 (Day281) [N=78;80]	0.240 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 8 (Day57) [N=83;84]	0.270 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 44 (Day309) [N=77;80]	0.250 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Day4 [N=83;84]	5.830 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 48 (Day337) [N=77;80]	0.250 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 12 (Day85) [N=83;83]	0.220 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 60 (Day421) [N=77;79]	0.250 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Day1 (3hr) [N=24;21]	88.020 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 72 (Day505) [N=77;78]	0.260 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 16 (Day113) [N=82;82]	0.245 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 84 (Day589) [N=76;77]	0.230 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 1 (Day8) [N=83;84]	3.190 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Week 96 (Day673) [N=75;75]	0.210 mIU/mL
TAP-144-SR (6M)	Concentration of Serum Luteinizing Hormone (LH)	Baseline [N=83;84]	4.250 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 96 (Day673) [N=75;75]	0.360 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Baseline [N=83;84]	4.490 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Day1 (1hr) [N=82;84]	30.585 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Day1 (3hr) [N=24;21]	63.260 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Day1 (6hr) [N=24;21]	61.210 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Day2 [N=83;84]	19.755 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Day3 [N=83;84]	10.500 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Day4 [N=83;84]	9.375 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 1 (Day8) [N=83;84]	4.475 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 2 (Day15) [N=83;84]	1.990 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 3 (Day22) [N=83;84]	1.085 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 4 (Day29) [N=83;84]	0.845 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 8 (Day57) [N=83;84]	0.570 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 12 (Day85) [N=83;83]	0.520 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 16 (Day113) [N=82;82]	0.430 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 20 (Day141) [N=81;82]	0.405 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 24 (Day169) [N=80;81]	0.460 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 25 (Day176) [N=79;80]	0.455 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 26 (Day183) [N=79;80]	0.405 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 28 (Day197) [N=75;77]	0.410 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 32 (Day225) [N=78;80]	0.440 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 36 (Day253) [N=79;80]	0.395 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 40 (Day281) [N=78;80]	0.390 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 44 (Day309) [N=77;80]	0.385 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 48 (Day337) [N=77;80]	0.415 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 60 (Day421) [N=77;79]	0.440 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 72 (Day505) [N=77;78]	0.420 mIU/mL
TAP-144-SR (3M)	Concentration of Serum Luteinizing Hormone (LH)	Week 84 (Day589) [N=76;77]	0.410 mIU/mL

Secondary

Disease Free Survival (DFS) Rate at Week 96

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.

Time frame: Week 96

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

Arm	Measure	Value (NUMBER)
TAP-144-SR (6M)	Disease Free Survival (DFS) Rate at Week 96	97.3 percentage of participants
TAP-144-SR (3M)	Disease Free Survival (DFS) Rate at Week 96	97.5 percentage of participants

Secondary

Distant Disease Free Survival (DDFS) Rate at Week 96

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.

Time frame: Week 96

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

Arm	Measure	Value (NUMBER)
TAP-144-SR (6M)	Distant Disease Free Survival (DDFS) Rate at Week 96	98.5 percentage of participants
TAP-144-SR (3M)	Distant Disease Free Survival (DDFS) Rate at Week 96	98.8 percentage of participants

Secondary

QT Interval Measured by 12-lead Electrocardiogram (ECG)

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).

Time frame: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
TAP-144-SR (6M)	QT Interval Measured by 12-lead Electrocardiogram (ECG)	Baseline [N=83;84]	421.5 millisecond (msec)	Standard Deviation 16.05
TAP-144-SR (6M)	QT Interval Measured by 12-lead Electrocardiogram (ECG)	Day1 (1hr) [N=83;84]	417.8 millisecond (msec)	Standard Deviation 15.37
TAP-144-SR (6M)	QT Interval Measured by 12-lead Electrocardiogram (ECG)	Day1 (3hr) [N=24;21]	416.8 millisecond (msec)	Standard Deviation 11.34
TAP-144-SR (6M)	QT Interval Measured by 12-lead Electrocardiogram (ECG)	Day1 (6hr) [N=24;21]	415.8 millisecond (msec)	Standard Deviation 18.68
TAP-144-SR (6M)	QT Interval Measured by 12-lead Electrocardiogram (ECG)	Week 4 (Day29) [N=83;84]	431.2 millisecond (msec)	Standard Deviation 19.3
TAP-144-SR (6M)	QT Interval Measured by 12-lead Electrocardiogram (ECG)	Week 12 (Day85) [N=83;84]	433.3 millisecond (msec)	Standard Deviation 19.44
TAP-144-SR (6M)	QT Interval Measured by 12-lead Electrocardiogram (ECG)	Week 24 (Day169) [N=81;82]	431.0 millisecond (msec)	Standard Deviation 21.22
TAP-144-SR (6M)	QT Interval Measured by 12-lead Electrocardiogram (ECG)	Week 48 (Day337) [N=77;80]	430.0 millisecond (msec)	Standard Deviation 17.31
TAP-144-SR (3M)	QT Interval Measured by 12-lead Electrocardiogram (ECG)	Week 48 (Day337) [N=77;80]	431.4 millisecond (msec)	Standard Deviation 18.89
TAP-144-SR (3M)	QT Interval Measured by 12-lead Electrocardiogram (ECG)	Baseline [N=83;84]	420.9 millisecond (msec)	Standard Deviation 16.53
TAP-144-SR (3M)	QT Interval Measured by 12-lead Electrocardiogram (ECG)	Week 4 (Day29) [N=83;84]	432.3 millisecond (msec)	Standard Deviation 16.9
TAP-144-SR (3M)	QT Interval Measured by 12-lead Electrocardiogram (ECG)	Day1 (1hr) [N=83;84]	417.1 millisecond (msec)	Standard Deviation 17.83
TAP-144-SR (3M)	QT Interval Measured by 12-lead Electrocardiogram (ECG)	Week 24 (Day169) [N=81;82]	429.0 millisecond (msec)	Standard Deviation 20.28
TAP-144-SR (3M)	QT Interval Measured by 12-lead Electrocardiogram (ECG)	Day1 (3hr) [N=24;21]	423.7 millisecond (msec)	Standard Deviation 18.9
TAP-144-SR (3M)	QT Interval Measured by 12-lead Electrocardiogram (ECG)	Week 12 (Day85) [N=83;84]	432.3 millisecond (msec)	Standard Deviation 20.01
TAP-144-SR (3M)	QT Interval Measured by 12-lead Electrocardiogram (ECG)	Day1 (6hr) [N=24;21]	424.1 millisecond (msec)	Standard Deviation 13.76

Secondary

Serum Unchanged TAP-144 Level

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

Time frame: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 36 (Day253) [N=79;80]	0.08521 nanogram per deciliter (ng/dL)	Standard Deviation 0.040324
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Day1 (1hr) [N=82;84]	5.293 nanogram per deciliter (ng/dL)	Standard Deviation 1.0684
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Day1 (3hr) [N=24;19]	2.538 nanogram per deciliter (ng/dL)	Standard Deviation 0.46023
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Day1 (6hr) [N=24;21]	1.039 nanogram per deciliter (ng/dL)	Standard Deviation 0.23264
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Day2 [N=83;84]	0.1401 nanogram per deciliter (ng/dL)	Standard Deviation 0.066137
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Day3 [N=83;84]	0.02889 nanogram per deciliter (ng/dL)	Standard Deviation 0.026108
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Day4 [N=83;84]	0.02380 nanogram per deciliter (ng/dL)	Standard Deviation 0.022645
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 1 (Day8) [N=82;83]	0.09115 nanogram per deciliter (ng/dL)	Standard Deviation 0.22637
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 2 (Day15) [N=82;84]	0.3702 nanogram per deciliter (ng/dL)	Standard Deviation 0.25134
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 3 (Day22) [N=83;84]	0.7285 nanogram per deciliter (ng/dL)	Standard Deviation 0.35639
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 4 (Day29) [N=83;83]	0.3442 nanogram per deciliter (ng/dL)	Standard Deviation 0.19814
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 8 (Day57) [N=83;83]	0.1146 nanogram per deciliter (ng/dL)	Standard Deviation 0.053068
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 12 (Day85) [N=83;83]	0.08051 nanogram per deciliter (ng/dL)	Standard Deviation 0.041881
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 16 (Day113) [N=82;82]	0.05775 nanogram per deciliter (ng/dL)	Standard Deviation 0.037098
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 20 (Day141) [N=81;82]	0.03941 nanogram per deciliter (ng/dL)	Standard Deviation 0.037082
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 24 (Day169) [N=80;81]	0.02931 nanogram per deciliter (ng/dL)	Standard Deviation 0.019785
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 25 (Day176) [N=79;80]	0.1128 nanogram per deciliter (ng/dL)	Standard Deviation 0.16751
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 26 (Day183) [N=79;80]	0.3327 nanogram per deciliter (ng/dL)	Standard Deviation 0.36474
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 28 (Day197) [N=80;80]	0.4687 nanogram per deciliter (ng/dL)	Standard Deviation 0.36083
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 32 (Day225) [N=78;80]	0.1377 nanogram per deciliter (ng/dL)	Standard Deviation 0.09334
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 40 (Day281) [N=79;80]	0.06073 nanogram per deciliter (ng/dL)	Standard Deviation 0.032232
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 44 (Day309) [N=77;80]	0.4339 nanogram per deciliter (ng/dL)	Standard Deviation 0.026552
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Week 48 (Day337) [N=77;80]	0.02957 nanogram per deciliter (ng/dL)	Standard Deviation 0.017147
TAP-144-SR (6M)	Serum Unchanged TAP-144 Level	Baseline [N=83;84]	0.000 nanogram per deciliter (ng/dL)	Standard Deviation 0
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 40 (Day281) [N=79;80]	0.08163 nanogram per deciliter (ng/dL)	Standard Deviation 0.031631
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Baseline [N=83;84]	0.000 nanogram per deciliter (ng/dL)	Standard Deviation 0
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 12 (Day85) [N=83;83]	0.06028 nanogram per deciliter (ng/dL)	Standard Deviation 0.031104
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Day1 (1hr) [N=82;84]	28.45 nanogram per deciliter (ng/dL)	Standard Deviation 9.7398
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 28 (Day197) [N=80;80]	0.08468 nanogram per deciliter (ng/dL)	Standard Deviation 0.04082
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Day1 (3hr) [N=24;19]	20.27 nanogram per deciliter (ng/dL)	Standard Deviation 3.9535
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 16 (Day113) [N=82;82]	0.09347 nanogram per deciliter (ng/dL)	Standard Deviation 0.077284
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Day1 (6hr) [N=24;21]	8.037 nanogram per deciliter (ng/dL)	Standard Deviation 1.7408
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 48 (Day337) [N=77;80]	0.06313 nanogram per deciliter (ng/dL)	Standard Deviation 0.032149
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Day2 [N=83;84]	0.4749 nanogram per deciliter (ng/dL)	Standard Deviation 0.17801
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 20 (Day141) [N=81;82]	0.07165 nanogram per deciliter (ng/dL)	Standard Deviation 0.062739
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Day3 [N=83;84]	0.2492 nanogram per deciliter (ng/dL)	Standard Deviation 0.097054
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 32 (Day225) [N=78;80]	0.06881 nanogram per deciliter (ng/dL)	Standard Deviation 0.037607
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Day4 [N=83;84]	0.2273 nanogram per deciliter (ng/dL)	Standard Deviation 0.080794
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 24 (Day169) [N=80;81]	0.07634 nanogram per deciliter (ng/dL)	Standard Deviation 0.064118
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 1 (Day8) [N=82;83]	0.1050 nanogram per deciliter (ng/dL)	Standard Deviation 0.049062
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 36 (Day253) [N=79;80]	0.06259 nanogram per deciliter (ng/dL)	Standard Deviation 0.036687
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 2 (Day15) [N=82;84]	0.08867 nanogram per deciliter (ng/dL)	Standard Deviation 0.077142
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 25 (Day176) [N=79;80]	0.1583 nanogram per deciliter (ng/dL)	Standard Deviation 0.089299
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 3 (Day22) [N=83;84]	0.06471 nanogram per deciliter (ng/dL)	Standard Deviation 0.092279
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 44 (Day309) [N=77;80]	0.06479 nanogram per deciliter (ng/dL)	Standard Deviation 0.02854
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 4 (Day29) [N=83;83]	0.04971 nanogram per deciliter (ng/dL)	Standard Deviation 0.032917
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 26 (Day183) [N=79;80]	0.1109 nanogram per deciliter (ng/dL)	Standard Deviation 0.065133
TAP-144-SR (3M)	Serum Unchanged TAP-144 Level	Week 8 (Day57) [N=83;83]	0.04744 nanogram per deciliter (ng/dL)	Standard Deviation 0.032379

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026

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

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants With Suppressive Effect of Serum Estradiol (E2) to Menopausal Level (=<30 pg/mL) From Week 4 Through Week 48

Concentration of Follicle Stimulating Hormone (FSH)

Concentration of Serum E2

Concentration of Serum Luteinizing Hormone (LH)

Disease Free Survival (DFS) Rate at Week 96

Distant Disease Free Survival (DDFS) Rate at Week 96

QT Interval Measured by 12-lead Electrocardiogram (ECG)

Serum Unchanged TAP-144 Level