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This single arm, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with a taxane as first line therapy in participants with HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant Herceptin treatment. Participants will receive Herceptin (loading dose of 4 mg/kg intravenously [iv], 2 mg/kg iv weekly thereafter) with 6 3-week cycles of either docetaxel (100 mg/m2 iv every 3 weeks) or paclitaxel (90 mg/m2 every week). Herceptin treatment will be continued until disease progression or unacceptable toxicity occurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab | Experimental | Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 100 mg/m2 iv every 3 weeks, 6 cycles (18 weeks) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 and was defined as the time from the date when the participant signed the informed consent form (ICF) until death or progressive disease (PD). PD was defined as 20% increase in the sum of the longest diameter of target lesions. PFS and associated confidence intervals were calculated using the Kaplan-Meier method. | From the date of informed consent to the date of death or progressive disease (up to 28 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall response rate was assessed using RECIST 1.0 and defined as the percentage of participants that achieved a complete response (CR) or a partial response (PR). CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | 100021 | China | ||||
A total of 32 participants were enrolled in the study and received study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab | Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Paclitaxel |
| Drug |
90 mg/kg iv (+/-10%) every 3 weeks for 6 3-week cycles (18 weeks) |
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| Trastuzumab | Drug | 4 mg/kg iv loading dose on Day 1, 2 mg/kg iv on Day 8 and weekly thereafter |
|
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| up to 28 months |
| Duration of Response | Duration of response was defined as the time from when a PR or CR was first documented until the date of documented PD or death. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. PD was defined as 20% increase in the sum of the longest diameter of target lesions. | From the time of PR or CR until the date of PD or death (up to 28 months) |
| Overall Survival | Overall survival was defined as the time from the date of enrollment to the date of death due to any cause. | Time from enrollment to the date of death (up to 28 months) |
| Percentage of Participants With an Adverse Event (AE) | An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment. | Up to 28 days after last infusion of the study drug (28 months) |
| Determination of Biomarkers Indicative for Response (Serum and Tumour Tissue Analyses) | up to 28 months |
| Clinical Benefit Rate | Clinical benefit rate was assessed according to RECIST 1.0 and defined as the percentage of participants who experienced a CR, PR, or stable disease (SD) for at least 6 months. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria. | up to 28 months |
| Time to Progression | Time to progression was defined as the time from the date of enrollment until the date of progressive disease. | From the date of enrollment until the date of progressive disease (up to 28 months) |
| Beijing |
| 100071 |
| China |
| Beijing | 100142 | China |
| Beijing | 100730 | China |
| Chengdu | 610041 | China |
| Guangzhou | 510060 | China |
| Guangzhou | 510515 | China |
| Guangzhou | China |
| Hangzhou | 310009 | China |
| Hangzhou | 310022 | China |
| Harbin | 150081 | China |
| Nanjing | 210009 | China |
| Shanghai | 200032 | China |
| Shenyang | 110001 | China |
| Wuhan | 430022 | China |
| Wuhan | 430030 | China |
| Zhengzhou | 450008 | China |
| COMPLETED |
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| NOT COMPLETED |
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Intention to treat (ITT) data set is defined as all the participants who are eligible through screening, register and enter the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab | Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
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| 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 | Progression-Free Survival (PFS) | PFS was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 and was defined as the time from the date when the participant signed the informed consent form (ICF) until death or progressive disease (PD). PD was defined as 20% increase in the sum of the longest diameter of target lesions. PFS and associated confidence intervals were calculated using the Kaplan-Meier method. | Intention to treat (ITT) data set is defined as all the participants who are eligible through screening, register and enter the study. | Posted | Median | 95% Confidence Interval | months | From the date of informed consent to the date of death or progressive disease (up to 28 months) |
|
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| |||||||||||||||||||||||||
| Secondary | Overall Response Rate | Overall response rate was assessed using RECIST 1.0 and defined as the percentage of participants that achieved a complete response (CR) or a partial response (PR). CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. | ITT data set is defined as all the participants who are eligible through screening, register and enter the study. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 28 months |
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| ||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response was defined as the time from when a PR or CR was first documented until the date of documented PD or death. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. PD was defined as 20% increase in the sum of the longest diameter of target lesions. | ITT data set is defined as all the participants who are eligible through screening, register and enter the study. Here, number of participants are the participants who had response. | Posted | Median | 95% Confidence Interval | months | From the time of PR or CR until the date of PD or death (up to 28 months) |
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| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the time from the date of enrollment to the date of death due to any cause. | ITT data set is defined as all the participants who are eligible through screening, register and enter the study. | Posted | Median | 95% Confidence Interval | months | Time from enrollment to the date of death (up to 28 months) |
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| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Adverse Event (AE) | An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment. | Safety population is defined as all enrolled participants and have taken at least one dose of study drug. | Posted | Number | percentage of participants | Up to 28 days after last infusion of the study drug (28 months) |
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| Secondary | Determination of Biomarkers Indicative for Response (Serum and Tumour Tissue Analyses) | Biomarker analysis was not performed as the eligible biomarker sample quantity was too limited for testing. | Posted | up to 28 months |
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| ||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate | Clinical benefit rate was assessed according to RECIST 1.0 and defined as the percentage of participants who experienced a CR, PR, or stable disease (SD) for at least 6 months. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria. | ITT data set is defined as all the participants who are eligible through screening, register and enter the study. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 28 months |
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| Secondary | Time to Progression | Time to progression was defined as the time from the date of enrollment until the date of progressive disease. | ITT data set is defined as all the participants who are eligible through screening, register and enter the study. | Posted | Median | 95% Confidence Interval | months | From the date of enrollment until the date of progressive disease (up to 28 months) |
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|
Up to 28 days after the last dose of the study drug (up to 28 months)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trastuzumab | Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies. | 5 | 32 | 29 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Completed suicide | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 14.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Transaminases increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Insomnia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Neurotoxicity | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Chest discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Paronychia | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Flushing | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Face oedema | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Hypophagia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Vomting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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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 |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D017239 | Paclitaxel |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| 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 |
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