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This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. In a parallel observational study patients with HER2-negative disease will receive the same chemotherapy without Herceptin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER-2+ Trastuzumab, Doxorubicin/Paclitaxel/CMF | Experimental | Participants with HER2 proto-oncogene positive breast cancer (HER2+) were treated with trastuzumab 8 milligrams per kilogram (mg/kg), intravenous (IV), on Day 1 of Cycle 1, followed by 6 mg/kg, IV, on Day 1 of Cycle 2 to up a maximum of Cycle 17. Participants also received doxorubicin 60 mg/ square meter (m^2), IV, and paclitaxel 150 mg/m^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF: cyclophosphamide 600 mg/m^2, IV; methotrexate 40 mg/m^2, IV; and 5-fluorouracil 600 mg/m^2, IV, on Day 1 of Cycles 8 through 10. |
|
| HER-2+ Doxorubicin/Paclitaxel/CMF | Active Comparator | Participants with HER2 proto-oncogene positive breast cancer were treated with doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF on Day 1 of Cycle 8 through 10. |
|
| HER-2- Doxorubicin/Paclitaxel/CMF | Active Comparator | Participants with HER2 proto-oncogene negative breast cancer were treated with doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF on Day 1 of Cycle 8 through 10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | 8mg/kg IV on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycle 2 up a maximum of Cycle 17 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-Free Survival (EFS) - Percentage of Participants With an Event | EFS was defined as the time between randomization and date of documented occurrence of disease recurrence or progression (local, regional, distant or contralateral) or death due to any cause. | Baseline (BL), Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
| Event-Free Survival | The median time, in months, between randomization and date of documented occurrence of an EFS event. | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
| Percentage of Participants Event Free at 1 Year | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter | |
| Percentage of Participants Event Free at 2 Years | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter | |
| Percentage of Participants Event Free at 3 Years | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Breast Pathological Complete Response (bpCR) | bpCR was defined as an absence of any invasive cancer cell of the primary tumor at the time of major surgery after neoadjuvant chemotherapy with and without trastuzumab. | BL, Day 1 of Cycles 1-10 (pre-surgery) |
| Percentage of Participants With Total Pathological Complete Response (tpCR) |
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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 |
|---|---|---|---|---|---|---|
| Vienna | 1090 | Austria | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | HER2+ Trastuzumab/Doxorubicin/Paclitaxel/CMF (HER2+TC) | Participants with human epidermal growth factor receptor 2 proto-oncogene positive (HER2+) breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 milligrams per kilogram (mg/kg), intravenously (IV) on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/square meter (mg/m^2), IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Doxorubicin | Drug | 60 mg/m2 IV on Day 1 of Cycles 1 through 3 |
|
| Paclitaxel | Drug | 150 mg/m2 IV on Day 1 of Cycles 1 through 3, followed by 175 mg/m2 IV on Day 1 of Cycles 4 through 7 |
|
| CMF | Drug | CMF: Cyclophosphamide (600 mg/m2 IV bolus), methotrexate (40 mg/m2 IV bolus), 5-fluorouracil (600 mg/m2 IV bolus) on Day 1 of Cycles 8 through 10 |
|
tpCR was defined as a determination of bpCR and an absence of positive axillary nodes on pathology. |
| BL, Day 1 of Cycles 1-10 (pre-surgery) |
| Percentage of Participants Achieving Either Complete Response (CR) or Partial Response (PR) According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | Assessments were made based on objective tumor measurements of the lesions as recorded in the case report form. In inflammatory cancer, progressive disease (PD) was defined as progression of any of the 2 signs of breast edema and erythema. In non-inflammatory cancer, PD was concluded if either the investigator judged the participant as having progressed at any time prior to surgery, or there was at least a 20% increase in the sum of target lesions (TLs), any new lesion, or clear progression of any nontarget lesion (NTLs). Clear progression of any NTL was defined as at least a 20% increase in the sum of NTLs compared to BL. PR was defined as at least a 30% decrease from BL in the sum of the longest diameter of TLs. CR was defined as no PD as assessed by the investigator and complete disappearance of all lesions. | BL, Presurgery: Day 1 of Cycles 1-10 |
| Overall Survival (OS) - Percentage of Participants With an Event | OS was defined as the time from the date of randomization to the date of the death due to any cause. | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
| Overall Survival | OS was defined as the time from the date of randomization to the date of the death due to any cause. | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
| Percentage of Participants Surviving at 1 Year | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
| Percentage of Participants Surviving at 2 Years | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
| Percentage of Participants Surviving at 3 Years | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
| München |
| 80637 |
| Germany |
| San Giovanni Rotondo | Apulia | 71013 | Italy |
| Bologna | Emilia-Romagna | 40138 | Italy |
| Carpi | Emilia-Romagna | 41012 | Italy |
| Udine | Friuli Venezia Giulia | 33100 | Italy |
| Milan | Lombardy | 20133 | Italy |
| Pavia | Lombardy | 27100 | Italy |
| Varese | Lombardy | 21100 | Italy |
| Sassari | Sardinia | 07100 | Italy |
| Trento | Trentino-Alto Adige | 38100 | Italy |
| Pisa | Tuscany | 56100 | Italy |
| Bellunoi | Veneto | 32100 | Italy |
| Castelfranco Veneto | Veneto | 31033 | Italy |
| Mirano | Veneto | 30035 | Italy |
| Santorso | Veneto | 36014 | Italy |
| Vicenza | Veneto | 36100 | Italy |
| Lisbon | 1099-023 | Portugal |
| Kazan' | 420029 | Russia |
| Moscow | 107005 | Russia |
| Moscow | 115478 | Russia |
| Moscow | 117837 | Russia |
| Moscow | 129128 | Russia |
| Saint Petersburg | 197022 | Russia |
| Saint Petersburg | 197758 | Russia |
| Barcelona | Barcelona | 08022 | Spain |
| Barcelona | Barcelona | 08035 | Spain |
| Barcelona | Barcelona | 08041 | Spain |
| Barcelona | Barcelona | 08907 | Spain |
| Terrassa | Barcelona | 08221 | Spain |
| Jerez de la Frontera | Cadiz | 11407 | Spain |
| Donostia / San Sebastian | Guipuzcoa | 20080 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Valencia | Valencia | 46009 | Spain |
| Valencia | Valencia | 46010 | Spain |
| Zaragoza | Zaragoza | 50009 | Spain |
| FG001 | HER2+ Doxorubicin/Paclitaxel/CMF (HER2+C) | Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. |
| FG002 | HER2- Doxorubicin/Paclitaxel/CMF (HER2-C) | Participants with human epidermal growth factor receptor proto-oncogene negative (HER2-) breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population: all participants who were randomized for the main study or registered for the observational parallel study and who received study medication at least once. Groups were analyzed as randomized/registered. Age was missing for 1 participant in the HER2+ TC treatment group.
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| ID | Title | Description |
|---|---|---|
| BG000 | HER2+ TC | Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years. |
| BG001 | HER2+ C | Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. |
| BG002 | HER2- C | Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. |
| BG003 | 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 | Event-Free Survival (EFS) - Percentage of Participants With an Event | EFS was defined as the time between randomization and date of documented occurrence of disease recurrence or progression (local, regional, distant or contralateral) or death due to any cause. | The full analysis set (FAS) included all participants who were randomized in the main study or registered in the parallel observational arm. | Posted | Number | percentage of participants | Baseline (BL), Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Breast Pathological Complete Response (bpCR) | bpCR was defined as an absence of any invasive cancer cell of the primary tumor at the time of major surgery after neoadjuvant chemotherapy with and without trastuzumab. | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | BL, Day 1 of Cycles 1-10 (pre-surgery) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Total Pathological Complete Response (tpCR) | tpCR was defined as a determination of bpCR and an absence of positive axillary nodes on pathology. | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | BL, Day 1 of Cycles 1-10 (pre-surgery) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Either Complete Response (CR) or Partial Response (PR) According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | Assessments were made based on objective tumor measurements of the lesions as recorded in the case report form. In inflammatory cancer, progressive disease (PD) was defined as progression of any of the 2 signs of breast edema and erythema. In non-inflammatory cancer, PD was concluded if either the investigator judged the participant as having progressed at any time prior to surgery, or there was at least a 20% increase in the sum of target lesions (TLs), any new lesion, or clear progression of any nontarget lesion (NTLs). Clear progression of any NTL was defined as at least a 20% increase in the sum of NTLs compared to BL. PR was defined as at least a 30% decrease from BL in the sum of the longest diameter of TLs. CR was defined as no PD as assessed by the investigator and complete disappearance of all lesions. | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | BL, Presurgery: Day 1 of Cycles 1-10 |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) - Percentage of Participants With an Event | OS was defined as the time from the date of randomization to the date of the death due to any cause. | FAS | Posted | Number | percentage of participants | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
| ||||||||||||||||||||||||||||||||||
| Primary | Event-Free Survival | The median time, in months, between randomization and date of documented occurrence of an EFS event. | FAS | Posted | Median | 95% Confidence Interval | months | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Event Free at 1 Year | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | OS was defined as the time from the date of randomization to the date of the death due to any cause. | FAS | Posted | Median | 95% Confidence Interval | months | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Surviving at 1 Year | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Event Free at 2 Years | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Surviving at 2 Years | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Event Free at 3 Years | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Surviving at 3 Years | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter |
|
BL, presurgery treatment Cycles 1-10, postsurgery Cycles 1-17, every 6 months thereafter for up to 60 months; yearly thereafter until primary analysis has taken place, after which serious adverse events were collected only if treatment related.
The safety analysis population included all participants randomized in the main study or registered in the parallel observational arm who received at least 1 dose of study medication. 20 participants in the HER2+C group crossed over to receive adjuvant trastuzumab after surgery; these participants were included in the HER+C group below.
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 | HER2+ TC | Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Day 1, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Days 1 and 8, followed by 1 week off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years. | 18 | 115 | 113 | 115 | ||
| EG001 | HER2+ C | Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. | 8 | 112 | 112 | 112 | ||
| EG002 | HER2- C | Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. | 9 | 99 | 98 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Wound abscess | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Tumour ulceration | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Alopecia totalis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hyperaemia | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | 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 | Hoffman-LaRoche | 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 |
|---|---|
| D000068878 | Trastuzumab |
| D004317 | Doxorubicin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| 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 |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| OG002 | HER2- C | Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. |
|
|
|
| OG002 | HER2- C | Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. |
|
|
|
| OG001 | HER2+ C | Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. |
| OG002 | HER2- C | Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. |
|
|
|
| OG002 | HER2- C | Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. |
|
|
| OG002 | HER2- C | Participants with HER2- breast cancer received doxorubicin, paclitaxel, and CMF as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Day 1, followed by 2 weeks off. |
|
|
|
| OG002 | HER2- C | Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. |
|
|
| OG002 | HER2- C | Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. |
|
|
|
| OG002 | HER2- C | Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. |
|
|
| OG002 | HER2- C | Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. |
|
|
| OG002 | HER2- C | Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. |
|
|
| OG002 | HER2- C | Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. |
|
|
| OG002 | HER2- C | Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off. |
|
|