Clinical trial NCT02748213: A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer
Official title: An Open-Label, Randomized Phase II Study of Herceptin (Trastuzumab), Taxotere (Docetaxel), and Xeloda (Capecitabine) in Combination, Versus Herceptin (Trastuzumab) Plus Taxotere (Docetaxel), in Patients With Advanced and/or Metastatic Breast Cancers That Overexpress HER2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-04-22
Enrollment: 225
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 intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed, HER2-positive advanced and/or metastatic breast cancer not amenable to curative therapy
* At least one measurable lesion according to RECIST
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Baseline left ventricular ejection fraction (LVEF) at least 50%

Exclusion Criteria:

* Pregnant, lactating, or women of childbearing potential who are not surgically sterile or not willing to use adequate contraceptive methods
* Previous treatment with Herceptin or other anti-HER therapies, or any previous chemotherapy for advanced or metastatic disease
* Past medical history significant for any cardiac or central nervous system (CNS) disorders
* Poor hematologic, renal, or hepatic function
* Chronic corticosteroid therapy

Primary outcomes:
measure: Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Secondary outcomes:
measure: Percentage of Participants With Death or Disease Progression According to RECIST
timeFrame: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
measure: Progression-Free Survival (PFS) According to RECIST
timeFrame: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
measure: Percentage of Participants Who Died
timeFrame: Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)
measure: Overall Survival (OS)
timeFrame: Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)
measure: Duration of Response (DOR) According to RECIST
timeFrame: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Other outcomes:
Locations:
city: Adelaide
country: Australia
city: Brisbane
country: Australia
city: Camperdown
country: Australia
city: Geelong
country: Australia
city: Melbourne
country: Australia
city: Melbourne
country: Australia
city: Perth
country: Australia
city: Southport
country: Australia
city: Porto Alegre
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Calgary
country: Canada
state: Alberta
city: Ottawa
country: Canada
state: Ontario
city: Quebec
country: Canada
city: San Jose
country: Costa Rica
city: Turku
country: Finland
city: Besancon
country: France
city: Grenoble
country: France
city: Marseille
country: France
city: Paris
country: France
city: Pierre Benite
country: France
city: Rennes
country: France
city: Athens
country: Greece
city: Heraklion
country: Greece
city: Patras
country: Greece
city: Guatemala City
country: Guatemala
city: Legnago
country: Italy
city: Noale
country: Italy
city: Rozzano
country: Italy
city: Trento
country: Italy
city: Treviglio
country: Italy
city: Distrito Federal
country: Mexico
city: Merida
country: Mexico
city: Monterrey
country: Mexico
city: Monterrey
country: Mexico
city: Panama City
country: Panama
city: Gdansk
country: Poland
city: Szczecin
country: Poland
city: Barcelona
country: Spain
city: Lerida
country: Spain
city: Sabadell, Barcelona
country: Spain
city: Zaragoza
country: Spain
city: Karlstad
country: Sweden
city: Västerås
country: Sweden
city: Ipswich
country: United Kingdom
city: Leeds
country: United Kingdom
city: Manchester
country: United Kingdom
city: Northwood
country: United Kingdom
city: Oxford
country: United Kingdom
city: Southampton
country: United Kingdom
city: Weston Super Mare
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
citation: Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.