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This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or metastatic breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Herceptin + Taxotere | Experimental | Participants will receive dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. |
|
| Herceptin + Taxotere + Xeloda | Experimental | Participants will receive triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xeloda | Drug | Participants will receive oral Xeloda, 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) | Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a best overall response for CR or PR was reported. The exact 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper method. | Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Death or Disease Progression According to RECIST | Tumor response was assessed by RECIST during the study. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants who died or experienced PD was reported. | Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide | 5011 | Australia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34037241 | Derived | Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Herceptin + Taxotere + Xeloda | Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via intravenous (IV) infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 milligrams per kilogram (mg/kg) in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 milligrams per meter-squared (mg/m^2), with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Taxotere | Drug | Participants will receive Taxotere, 75 milligrams per meter-squared (mg/m^2) in the Herceptin + Taxotere + Xeloda arm or 100 mg/m^2 in the Herceptin + Taxotere arm, via IV infusion on Day 1 of each 21-day cycle. The lower starting dose will be used in the triple-therapy arm. |
|
|
| Herceptin | Drug | Participants will receive Herceptin, 6 milligrams per kilogram (mg/kg) via IV infusion, on Day 1 of each 21-day cycle. The first dose will be a loading dose of 8 mg/kg in Cycle 1; the dose of 6 mg/kg will be given from Cycle 2 onward. |
|
|
| Progression-Free Survival (PFS) According to RECIST | Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. Participants without event at the time of analysis were censored at the latest date of last tumor assessment or last date in drug log. The median duration of PFS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months. | Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall) |
| Percentage of Participants Who Died | The percentage of participants who died from any cause was reported. | Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall) |
| Overall Survival (OS) | OS was defined as the time from start of treatment to date of death for any reason. Participants who were alive at the time of analysis were censored at the latest date of last tumor assessment, last drug intake, or last follow-up information. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months. | Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall) |
| Duration of Response (DOR) According to RECIST | Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. DOR was defined as the time from first assessment of CR or PR until the first occurrence of documented PD, death, or withdrawal. The median DOR was reported and expressed in months. | Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall) |
| Brisbane |
| 4066 |
| Australia |
| Camperdown | 2050 | Australia |
| Geelong | 3220 | Australia |
| Melbourne | 3002 | Australia |
| Melbourne | 3181 | Australia |
| Perth | 6000 | Australia |
| Southport | 4215 | Australia |
| Porto Alegre | 91350-200 | Brazil |
| Rio de Janeiro | 20560-120 | Brazil |
| São Paulo | 01401-901 | Brazil |
| Calgary | Alberta | T2N 4N2 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Québec | Quebec | G1S 4L8 | Canada |
| San José | 10103 | Costa Rica |
| Turku | 20520 | Finland |
| Besançon | 25030 | France |
| Grenoble | 38000 | France |
| Marseille | 13273 | France |
| Paris | 75231 | France |
| Pierre-Bénite | 69310 | France |
| Rennes | 35042 | France |
| Athens | 11526 | Greece |
| Heraklion | 71110 | Greece |
| Pátrai | 26500 | Greece |
| Guatemala City | 01010 | Guatemala |
| Legnago | 37045 | Italy |
| Noale | 30033 | Italy |
| Rozzano | 20089 | Italy |
| Trento | 38100 | Italy |
| Treviglio | 24047 | Italy |
| Distrito Federal | 14080 | Mexico |
| Mérida | 97500 | Mexico |
| Monterrey | 64020 | Mexico |
| Monterrey | 64060 | Mexico |
| Panama City | 0 | Panama |
| Gdansk | 80-214 | Poland |
| Szczecin | 71-730 | Poland |
| Barcelona | 08035 | Spain |
| Lleida | 25198 | Spain |
| Sabadell, Barcelona | 08208 | Spain |
| Zaragoza | 50009 | Spain |
| Karlstad | 65185 | Sweden |
| Västerås | 72189 | Sweden |
| Ipswich | IP4 5PD | United Kingdom |
| Leeds | LS9 7TF | United Kingdom |
| Manchester | M20 4BX | United Kingdom |
| Northwood | HA6 2RN | United Kingdom |
| Oxford | OX3 7LJ | United Kingdom |
| Southampton | SO16 6YD | United Kingdom |
| Weston-super-Mare | BS23 4TQ | United Kingdom |
| FG001 | Herceptin + Taxotere | Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
|
|
Full Analysis Set (FAS) Population: All participants, according to randomization scheme, who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Herceptin + Taxotere + Xeloda | Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity. |
| BG001 | Herceptin + Taxotere | Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity. |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) | Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a best overall response for CR or PR was reported. The exact 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper method. | Full Analysis Set (FAS) Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Death or Disease Progression According to RECIST | Tumor response was assessed by RECIST during the study. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants who died or experienced PD was reported. | FAS Population. | Posted | Number | percentage of participants | Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) According to RECIST | Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. Participants without event at the time of analysis were censored at the latest date of last tumor assessment or last date in drug log. The median duration of PFS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months. | FAS Population. | Posted | Median | 95% Confidence Interval | months | Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Died | The percentage of participants who died from any cause was reported. | FAS Population. | Posted | Number | percentage of participants | Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from start of treatment to date of death for any reason. Participants who were alive at the time of analysis were censored at the latest date of last tumor assessment, last drug intake, or last follow-up information. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months. | FAS Population. | Posted | Median | 95% Confidence Interval | months | Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) According to RECIST | Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. DOR was defined as the time from first assessment of CR or PR until the first occurrence of documented PD, death, or withdrawal. The median DOR was reported and expressed in months. | FAS Population. The "Number of Participants Analyzed" reflects the number of participants with a best overall response of CR or PR who provided evaluable data for the analysis. | Posted | Median | Full Range | months | Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall) |
|
Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
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 | Herceptin + Taxotere + Xeloda | Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity. | 52 | 112 | 112 | 112 | ||
| EG001 | Herceptin + Taxotere | Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity. | 51 | 110 | 107 | 110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Central line infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Wound sepsis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Inflammation of wound | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pitting oedema | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Diplegia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Acute lymphocytic leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
| |
| Neurosis | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Nail toxicity | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077143 | Docetaxel |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
|
|
| Herceptin + Taxotere |
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity. |
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| OG001 | Herceptin + Taxotere | Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity. |
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