A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Breast Cancer |
| Intervention | Drug: trastuzumab [Herceptin] Drug: Doxorubicin Drug: Paclitaxel Drug: CMF |
| Phase | Phase 3 |
| Sponsor | Hoffmann-La Roche |
| Responsible Party | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier | NCT01998906 |
| First Received | November 25, 2013 |
| Last Updated | December 3, 2013 |
| Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 25, 2013 |
|---|---|
| Last Updated Date | December 3, 2013 |
| Start Date | May 2002 |
| Estimated Primary Completion Date | July 2012 |
| Current Primary Outcome Measures | Event-free survival [Time Frame: Approximately 9 years] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer |
|---|---|
| Official Title | A Randomized, Open-label Study of the Effect of Paclitaxel, Doxorubicin, and CMF Neoadjuvant Chemotherapy, With and Without Herceptin, on Tumor Response in Women With HER2-positive Breast Cancer |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Breast Cancer |
| Intervention | Drug: trastuzumab [Herceptin] Neoadjuvant: Loading dose of 8 mg/kg intravenous infusion (IV), subsequent doses were 6 mg/kg. Following surgery, adjuvant treatment with Herceptin could be re-started (loading dose 8 mg/kg IV, subsequent doses 6 mg/kg) before or during radiotherapy treatment until 1 year after starting. Drug: Doxorubicin Doxorubicin (60 mg/m2 intravenous [IV] infusion) every 3 weeks for 3 cycles Drug: Paclitaxel Paclitaxel 150 mg/m2 IV infusion every 3 weeks for 3 cycles in combination with doxorubicin, followed by paclitaxel alone 175 mg/m2 IV infusion every 3 weeks for 4 cycles Drug: CMF CMF: Cyclophosphamide (600 mg/m2 IV bolus), methotrexate (40 mg/m2 IV bolus), 5-fluorouracil (600 mg/m2 IV bolus) every 4 weeks for 3 cycles |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 334 |
| Estimated Completion Date | July 2012 |
| Estimated Primary Completion Date | July 2012 |
| Eligibility Criteria | Inclusion Criteria: - female patients, >=18 years of age, with locally advanced breast cancer. Exclusion Criteria: - previous therapy for any invasive malignancy. |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Austria, Germany, Italy, Portugal, Russian Federation, Spain |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01998906 |
|---|---|
| Other Study ID Numbers | MO16432 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Hoffmann-La Roche |
| Study Sponsor | Hoffmann-La Roche |
| Collaborators | Not Provided |
| Investigators | Study Chair: Clinical Trials Hoffmann-La Roche |
| Verification Date | December 2013 |
Locations[ + expand ][ + ]
| Austria | Wien, Austria, 1090 |
|---|---|
| Germany | Muenchen, Germany, 80637 |
| Italy, Emilia-Romagna | Bologna, Emilia-Romagna, Italy, 40138 |
| Italy, Emilia-Romagna | Carpi, Emilia-Romagna, Italy, 41012 |
| Italy, Friuli-Venezia Giulia | Udine, Friuli-Venezia Giulia, Italy, 33100 |
| Italy, Lombardia | Milano, Lombardia, Italy, 20133 |
| Italy, Lombardia | Pavia, Lombardia, Italy, 27100 |
| Italy, Lombardia | Varese, Lombardia, Italy, 21100 |
| Italy, Puglia | San Giovanni Rotondo, Puglia, Italy, 71013 |
| Italy, Sardegna | Sassari, Sardegna, Italy, 07100 |
| Italy, Toscana | Pisa, Toscana, Italy, 56100 |
| Italy, Trentino-Alto Adige | Trento, Trentino-Alto Adige, Italy, 38100 |
| Italy, Veneto | Bellunoi, Veneto, Italy, 32100 |
| Italy, Veneto | Castelfranco Veneto, Veneto, Italy, 31033 |
| Italy, Veneto | Mirano, Veneto, Italy, 30035 |
| Italy, Veneto | Santorso, Veneto, Italy, 36014 |
| Italy, Veneto | Vicenza, Veneto, Italy, 36100 |
| Portugal | Lisboa, Portugal, 1099-023 |
| Russian Federation | Kazan, Russian Federation, 420029 |
| Russian Federation | Moscow, Russian Federation, 115478 |
| Russian Federation | Moscow, Russian Federation, 117837 |
| Russian Federation | Moscow, Russian Federation, 129128 |
| Russian Federation | Moscow, Russian Federation, 107005 |
| Russian Federation | Saint-Petersburg, Russian Federation, 197758 |
| Russian Federation | St Petersburg, Russian Federation, 197022 |
| Spain, Barcelona | Terrassa, Barcelona, Spain, 08221 |
| Spain, Cadiz | Jerez de La Frontera, Cadiz, Spain, 11407 |
| Spain, Guipuzcoa | San Sebastian, Guipuzcoa, Spain, 20080 |
| Spain | Barcelona, Spain, 08907 |
| Spain | Barcelona, Spain, 08035 |
| Spain | Barcelona, Spain, 08041 |
| Spain | Barcelona, Spain, 08022 |
| Spain | Madrid, Spain, 28041 |
| Spain | Valencia, Spain, 46009 |
| Spain | Valencia, Spain, 46010 |
| Spain | Zaragoza, Spain, 50009 |