Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Hormones

Leuprolide

Antineoplastic Agents, Hormonal

TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 96 weeks.

TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 96 weeks.

TAP-144-SR(6M)

TAP-144-SR(3M)

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

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

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.

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

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

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

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.

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.

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

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).

Takeda

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.

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 (6M)

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.

TAP-144-SR (3M)

Total

Age, Continuous

Less than (<) 40 years

Greater than equal to (>=) 40 to <45 years

>=45 years

Age, Customized

Sex: Female, Male

Height

<150 cm

>=150 to <160 cm

>=160 cm

Height, Customized

Weight

<50 kg

>=50 to <60 kg

>=60 kg

Weight, Customized

Body Mass Index (BMI)

<18.5 kg/m^2

>=18.5 to <25.0 kg/m^2

>=25.0 to <30.0 kg/m^2

>=30.0 kg/m^2

BMI, Customized

Breast-conserving surgery

Mastectomy

Surgical procedure, Customized

Papillotubular carcinoma

Solid-tubular carcinoma

Scirrhous carcinoma

Mucinous carcinoma

Invasive lobular carcinoma

Tubular adenocarcinoma

Invasive micropapillary carcinoma

Specified neoplasms (other)

Pathological diagnosis, Customized

The frequency of clinical tumor stage T (0, 1, 2, 3, 4, X, or Tis) was assessed. The frequency of T was evaluated prior to surgery. The categories of T are ranged from 0 (No evidence of primary tumor) to 4 (Tumor of any size with direct extension to chest wall and/or to skin). X is representing tumor cannot be evaluated, 0 is representing no signs of tumor, Tis is carcinoma in situ.

TNM classification: clinical tumor stage T, Customized

The frequency of regional lymph nodes stage N (0, 1, 2, 3, or X) was assessed. The frequency of N was evaluated prior to surgery. The categories of N are ranged from 0 (No regional lymph node metastasis) to 3 (Metastasis in ipsilateral infraclavicular lymph node(s); or in clinically detected ipsilateral internal mammary lymph node(s); or metastasis in ipsilateral supraclavicular lymph node(s)). X is representing lymph nodes cannot be evaluated, 0 is tumor cells absent from regional lymph nodes.

TNM classification: regional lymph node stage N, Customized

The frequency of distant metastasis clinical stage M (0, 1) was assessed. The frequency of M was evaluated prior to surgery. The categories of M are represented by 0 (no distant metastasis) and 1 (distant metastasis).

TNM classification: M0

IIIA

The stage of cancer based on TNM classification: Stage 0 (Carcinoma in situ which is staged by Tis, N0, M0), Stage IA (T1, N0, M0), IB (T0/T1, N1, M0), IIA (T0/T1, N1, M0 or T2, N0, M0), IIB (T2, N1, M0 or T3, N0, M0), IIIA (T0/T1/T2, N2, M0 or T3, N1/N2, M0), IIIB (T4, N0/N1/N2, M0) and IIIC (Any T, N3, M0), Stage IV(Any T, Any N, M1).

TNM staging (Stage), Customized

Histopathological tumor size

Less than equal to (<=) 2.0 cm

>2.0 cm

Histopathological tumor size, Customized

Axillary lymph node metastases

Present

Absent

Axillary lymph node metastases, Customized

>=1 metastasis to <=3 metastases

>=4 metastases

<=28 days

>=29 to <=56 days

>=57 days

Time from surgery or previous postoperative adjuvant therapy to administration of study drug

ER -positive / PgR-positive

ER -positive / PgR -negative

ER -negative / PgR -positive

Primary tumor estrogen receptors (ER)/ progesterone receptors (PgR) status, Customized

Not performed

Participants with HER expression by IHC was reported as 0, 1+, 2+, 3+, or unmeasured. The categories of HER expression is ranged from 0 (better) to 3+ (worse).

Human epidermal growth factor receptor 2 (HER2) (immunohistochemistry [IHC] scoring), Customized

Positive

Negative

Equivocal

HER2 (fluorescent in situ hybridization [FISH] testing), Customized

Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair.

The eastern cooperative oncology group performance status (ECOG P.S.), Customized

Menstruation (before the first dose), Customized

Time from last menstruation to first dose

Missing

Time from last menstruation to first dose, Customized

Serum Estradiol (E2) concentration (pretreatment)

<=29 pg/mL

>=30 pg/mL

Serum E2 concentration (pretreatment), Customized

Participants were classified based on whether they had received radiation therapy or not.

Radiation, Customized

Preoperative and postoperative chemotherapy, Customized

Previous breast cancer (other), Customized

Concomitant osteoporosis medication , Customized

Never Smoked

Current Smoker

Ex-smoker

Smoking Classification, Customized

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

Medical Director

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

Baseline [N=83;84]

Day1 (1hr) [N=82;84]

Day1 (3hr) [N=24;21]

Day1 (6hr) [N=24;21]

Day2 [N=83;84]

Day3 [N=83;84]

Day4 [N=83;84]

Week 1 (Day8) [N=83;84]

Week 2 (Day15) [N=83;84]

Week 3 (Day22) [N=83;84]

Week 4 (Day29) [N=83;84]

Week 8 (Day57) [N=83;84]

Week 12 (Day85) [N=83;83]

Week 16 (Day113) [N=82;82]

Week 20 (Day141) [N=81;82]

Week 24 (Day169) [N=80;81]

Week 25 (Day176) [N=79;80]

Week 26 (Day183) [N=79;80]

Week 28 (Day197) [N=75;77]

Week 32 (Day225) [N=78;80]

Week 36 (Day253) [N=79;80]

Week 40 (Day281) [N=78;80]

Week 44 (Day309) [N=77;80]

Week 48 (Day337) [N=77;80]

Week 60 (Day421) [N=77;79]

Week 72 (Day505) [N=77;78]

Week 84 (Day589) [N=76;77]

Week 96 (Day673) [N=75;75]

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.

Concentration of Serum E2

Concentration of Serum Luteinizing Hormone (LH)

Concentration of Follicle Stimulating Hormone (FSH)

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

Disease Free Survival (DFS) Rate at Week 96

Distant Disease Free Survival (DDFS) Rate at Week 96

Day1 (3hr) [N=24;19]

Week 1 (Day8) [N=82;83]

Week 2 (Day15) [N=82;84]

Week 4 (Day29) [N=83;83]

Week 8 (Day57) [N=83;83]

Week 28 (Day197) [N=80;80]

Week 40 (Day281) [N=79;80]

Serum Unchanged TAP-144 Level

Day1 (1hr) [N=83;84]

Week 12 (Day85) [N=83;84]

Week 24 (Day169) [N=81;82]

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

QT Interval Measured by 12-lead Electrocardiogram (ECG)

Overall Study

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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