Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-121762 | Registry Identifier | JapicCTI | |
| U1111-1128-7039 | Registry Identifier | WHO |
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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
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP-144-SR(6M) | Experimental | TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 96 weeks. |
|
| TAP-144-SR(3M) | Active Comparator | TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 96 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP-144-SR(6M) | Drug |
| ||
| TAP-144-SR(3M) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 up to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Serum E2 | The measure indicates serum E2 concentration at baseline and post-baseline time points. | 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 |
| Concentration of Serum Luteinizing Hormone (LH) |
Not provided
Inclusion Criteria:
The participant has histopathologically-confirmed primary breast cancer in Japanese.
The participant is aged 20 years or older when informed consent is obtained
The participant has estrogen receptor (ER)-positive tumor cells and/or progesterone receptor (PgR)-positive primary tumor. And HER-2 is negative.
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.
Any operative procedure for breast cancer is acceptable. In principle, after breast-conserving surgery, the participant will receive postoperative radiation to the conserving breast.
Neoadjuvant chemotherapy and adjuvant chemotherapy prior to study enrollment are acceptable. (It is advisable the same kind of chemotherapy is performed at each site.)
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.
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.
The participant has ECOG performance status of grades 0 or 1 at the time of study enrollment.
The participant meets the following criteria of hepatic, renal and bone marrow functions on the laboratory test results at screening:
The participant agrees to use a non-hormonal method of contraception through the study period.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | Japan | ||||
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 took part in the study at 21 investigative sites in Japan from April 2012 to December 2014.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | TAP-144-SR (3M) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
This measure indicates serum LH concentration at baseline and post-baseline time points. It was measured in milli-international units per milliliter (mIU/mL). |
| 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 |
| Concentration of Follicle Stimulating Hormone (FSH) | This measure indicates serum FSH concentration at baseline and post-baseline time points. | 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 |
| 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. | Week 96 |
| 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. | Week 96 |
| Serum Unchanged TAP-144 Level | This measure indicates the unchanged TAP-144 level in serum. | 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 |
| 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). | Baseline, Hour 1, 3, 6 on Day 1, Day 29, 85, 169 and 337 |
| Fukushima |
| Fukushima |
| Japan |
| Maebashi | Gunma | Japan |
| Ohta-shi | Gunma | Japan |
| Sapporo | Hokkaido | Japan |
| Isehara-shi | Kanagawa | Japan |
| Yokohama | Kanagawa | Japan |
| Kumamoto | Kumamoto | Japan |
| Kyoto | Kyoto | Japan |
| Nigata-shi | Niigata | Japan |
| Kurashiki-shi | Okayama-ken | Japan |
| Osaka | Osaka | Japan |
| Suita-shi | Osaka | Japan |
| Kita-adachi-gun | Saitama | Japan |
| Shinjuku-ku | Tokyo | Japan |
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.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) included all randomized participants who had received at least a single dose of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | centimeter (cm) |
| |||||||||||||||
| Height, Customized | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kilogram (kg) |
| |||||||||||||||
| Weight, Customized | Number | participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
| |||||||||||||||
| BMI, Customized | Number | participants |
| ||||||||||||||||
| Surgical procedure, Customized | Number | participants |
| ||||||||||||||||
| Pathological diagnosis, Customized | Number | participants |
| ||||||||||||||||
| TNM classification: clinical tumor stage T, 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. | Number | participants |
| |||||||||||||||
| TNM classification: regional lymph node stage N, 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. | Number | participants |
| |||||||||||||||
| TNM classification: M0 | 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). | Number | participants |
| |||||||||||||||
| TNM staging (Stage), Customized | 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). | Number | participants |
| |||||||||||||||
| Histopathological tumor size | Mean | Standard Deviation | cm |
| |||||||||||||||
| Histopathological tumor size, Customized | Number | participants |
| ||||||||||||||||
| Axillary lymph node metastases | Mean | Standard Deviation | number of metastases |
| |||||||||||||||
| Axillary lymph node metastases, Customized | Number | participants |
| ||||||||||||||||
| Axillary lymph node metastases, Customized | Number | participants |
| ||||||||||||||||
| Time from surgery or previous postoperative adjuvant therapy to administration of study drug | Number | participants |
| ||||||||||||||||
| Primary tumor estrogen receptors (ER)/ progesterone receptors (PgR) status, Customized | Number | participants |
| ||||||||||||||||
| Human epidermal growth factor receptor 2 (HER2) (immunohistochemistry [IHC] scoring), Customized | 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). | Number | participants |
| |||||||||||||||
| HER2 (fluorescent in situ hybridization [FISH] testing), Customized | Number | participants |
| ||||||||||||||||
| The eastern cooperative oncology group performance status (ECOG P.S.), 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. | Number | participants |
| |||||||||||||||
| Menstruation (before the first dose), Customized | Number | participants |
| ||||||||||||||||
| Time from last menstruation to first dose | Mean | Standard Deviation | days |
| |||||||||||||||
| Time from last menstruation to first dose, Customized | Number | participants |
| ||||||||||||||||
| Serum Estradiol (E2) concentration (pretreatment) | Mean | Standard Deviation | picogram per milliliter (pg/mL) |
| |||||||||||||||
| Serum E2 concentration (pretreatment), Customized | Number | participants |
| ||||||||||||||||
| Radiation, Customized | Participants were classified based on whether they had received radiation therapy or not. | Number | participants |
| |||||||||||||||
| Preoperative and postoperative chemotherapy, Customized | Number | participants |
| ||||||||||||||||
| Previous breast cancer (other), Customized | Number | participants |
| ||||||||||||||||
| Concomitant osteoporosis medication , Customized | Number | participants |
| ||||||||||||||||
| Smoking Classification, Customized | Number | participants |
| ||||||||||||||||
| Time from surgery or previous postoperative adjuvant therapy to administration of study drug | Mean | Standard Deviation | days |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full analysis set (FAS) included all randomized participants who had received at least a single dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 up to Week 48 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Concentration of Serum E2 | The measure indicates serum E2 concentration at baseline and post-baseline time points. | 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. | Posted | Median | Full Range | pg/mL | 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 |
|
| |||||||||||||||||||||||||||||
| 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). | 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. | Posted | Median | Full Range | mIU/mL | 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 |
|
| |||||||||||||||||||||||||||||
| Secondary | Concentration of Follicle Stimulating Hormone (FSH) | This measure indicates serum FSH concentration at baseline and post-baseline time points. | 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. | Posted | Median | Full Range | mIU/mL | 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 |
|
| |||||||||||||||||||||||||||||
| 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. | FAS included all randomized participants who had received at least a single dose of study treatment. | Posted | Number | percentage of participants | Week 96 |
|
| ||||||||||||||||||||||||||||||
| 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. | FAS included all randomized participants who had received at least a single dose of study treatment. | Posted | Number | percentage of participants | Week 96 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Serum Unchanged TAP-144 Level | This measure indicates the unchanged TAP-144 level in serum. | 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. | Posted | Mean | Standard Deviation | nanogram per deciliter (ng/dL) | 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 |
|
| |||||||||||||||||||||||||||||
| 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). | Safety evaluation was conducted in the safety analysis set (SAS). Here 'N' represents evaluable baseline and post-baseline assessment population. | Posted | Mean | Standard Deviation | millisecond (msec) | Baseline, Hour 1, 3, 6 on Day 1, Day 29, 85, 169 and 337 |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 6 | 83 | 82 | 83 | ||
| EG001 | 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. | 7 | 84 | 82 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelid ptosis | Eye disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Behcet's syndrome | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Bone density decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | clinicaltrialregistry@tpna.com |
| Greater than equal to (>=) 40 to <45 years |
|
| >=45 years |
|
| Male |
|
| >=150 to <160 cm |
|
| >=160 cm |
|
| >=50 to <60 kg |
|
| >=60 kg |
|
| >=18.5 to <25.0 kg/m^2 |
|
| >=25.0 to <30.0 kg/m^2 |
|
| >=30.0 kg/m^2 |
|
| Mastectomy |
|
| Solid-tubular carcinoma |
|
| Scirrhous carcinoma |
|
| Mucinous carcinoma |
|
| Invasive lobular carcinoma |
|
| Tubular adenocarcinoma |
|
| Invasive micropapillary carcinoma |
|
| Specified neoplasms (other) |
|
| T2 |
|
| T3 |
|
| N1 |
|
| IIA |
|
| IIB |
|
| IIIA |
|
| >2.0 cm |
|
| Absent |
|
| >=1 metastasis to <=3 metastases |
|
| >=4 metastases |
|
| >=29 to <=56 days |
|
| >=57 days |
|
| ER -positive / PgR -negative |
|
| ER -negative / PgR -positive |
|
| 1+ |
|
| 2+ |
|
| 3+ |
|
| Not performed |
|
| Negative |
|
| Equivocal |
|
| Not performed |
|
| 1 |
|
| Absent |
|
| >=29 to <=56 days |
|
| >=57 days |
|
| Missing |
|
| >=30 pg/mL |
|
| Absent |
|
| Absent |
|
| Absent |
|
| Absent |
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| Current Smoker |
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| Ex-smoker |
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|
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