Clinical trial NCT01998906: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-02
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* previous therapy for any invasive malignancy.

Primary outcomes:
measure: Event-Free Survival (EFS) - Percentage of Participants With an Event
timeFrame: 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
measure: Event-Free Survival
timeFrame: 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: Percentage of Participants Event Free at 1 Year
timeFrame: 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: Percentage of Participants Event Free at 2 Years
timeFrame: 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: Percentage of Participants Event Free at 3 Years
timeFrame: 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 outcomes:
measure: Percentage of Participants With Breast Pathological Complete Response (bpCR)
timeFrame: BL, Day 1 of Cycles 1-10 (pre-surgery)
measure: Percentage of Participants With Total Pathological Complete Response (tpCR)
timeFrame: BL, Day 1 of Cycles 1-10 (pre-surgery)
measure: Percentage of Participants Achieving Either Complete Response (CR) or Partial Response (PR) According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
timeFrame: BL, Presurgery: Day 1 of Cycles 1-10
measure: Overall Survival (OS) - Percentage of Participants With an Event
timeFrame: 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: Overall Survival
timeFrame: 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: Percentage of Participants Surviving at 1 Year
timeFrame: 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: Percentage of Participants Surviving at 2 Years
timeFrame: 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: Percentage of Participants Surviving at 3 Years
timeFrame: 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
Other outcomes:
Locations:
city: Wien
country: Austria
city: Muenchen
country: Germany
city: Bologna
country: Italy
state: Emilia-Romagna
city: Carpi
country: Italy
state: Emilia-Romagna
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Milano
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Varese
country: Italy
state: Lombardia
city: San Giovanni Rotondo
country: Italy
state: Puglia
city: Sassari
country: Italy
state: Sardegna
city: Pisa
country: Italy
state: Toscana
city: Trento
country: Italy
state: Trentino-Alto Adige
city: Bellunoi
country: Italy
state: Veneto
city: Castelfranco Veneto
country: Italy
state: Veneto
city: Mirano
country: Italy
state: Veneto
city: Santorso
country: Italy
state: Veneto
city: Vicenza
country: Italy
state: Veneto
city: Lisboa
country: Portugal
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Terrassa
country: Spain
state: Barcelona
city: Jerez de La Frontera
country: Spain
state: Cadiz
city: San Sebastian
country: Spain
state: Guipuzcoa
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: