A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01998906
First received: November 25, 2013
Last updated: December 3, 2013
Last verified: December 2013
  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 Intervention Phase
Breast Cancer
Drug: trastuzumab [Herceptin]
Drug: Doxorubicin
Drug: Paclitaxel
Drug: CMF
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: Approximately 9 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pathological complete response rate [ Time Frame: Approximately 8 months ] [ Designated as safety issue: No ]
  • Overall clinical response rate [ Time Frame: Approximately 8 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Approximately 9 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: Approximately 9 years ] [ Designated as safety issue: No ]
  • Changes in left ventricular ejection fraction (LVEF) [ Time Frame: From baseline to approximately 9 years ] [ Designated as safety issue: No ]

Enrollment: 334
Study Start Date: May 2002
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy + Herceptin 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
Active Comparator: Chemotherapy 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female patients, >=18 years of age, with locally advanced breast cancer.

Exclusion Criteria:

  • previous therapy for any invasive malignancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01998906

Locations
Austria
Wien, Austria, 1090
Germany
Muenchen, Germany, 80637
Italy
Bologna, Emilia-Romagna, Italy, 40138
Carpi, Emilia-Romagna, Italy, 41012
Udine, Friuli-Venezia Giulia, Italy, 33100
Milano, Lombardia, Italy, 20133
Pavia, Lombardia, Italy, 27100
Varese, Lombardia, Italy, 21100
San Giovanni Rotondo, Puglia, Italy, 71013
Sassari, Sardegna, Italy, 07100
Pisa, Toscana, Italy, 56100
Trento, Trentino-Alto Adige, Italy, 38100
Bellunoi, Veneto, Italy, 32100
Castelfranco Veneto, Veneto, Italy, 31033
Mirano, Veneto, Italy, 30035
Santorso, Veneto, Italy, 36014
Vicenza, Veneto, Italy, 36100
Portugal
Lisboa, Portugal, 1099-023
Russian Federation
Kazan, Russian Federation, 420029
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 117837
Moscow, Russian Federation, 129128
Moscow, Russian Federation, 107005
Saint-Petersburg, Russian Federation, 197758
St Petersburg, Russian Federation, 197022
Spain
Terrassa, Barcelona, Spain, 08221
Jerez de La Frontera, Cadiz, Spain, 11407
San Sebastian, Guipuzcoa, Spain, 20080
Barcelona, Spain, 08907
Barcelona, Spain, 08035
Barcelona, Spain, 08041
Barcelona, Spain, 08022
Madrid, Spain, 28041
Valencia, Spain, 46009
Valencia, Spain, 46010
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01998906     History of Changes
Other Study ID Numbers: MO16432
Study First Received: November 25, 2013
Last Updated: December 3, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Liposomal doxorubicin
Trastuzumab
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 01, 2014