A Study of Pertuzumab in Combination With Herceptin (Trastuzumab) And Vinorelbine in First Line in Patients With Metastatic or Locally Advanced HER2-Positive Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01565083
First received: March 26, 2012
Last updated: August 19, 2014
Last verified: August 2014

March 26, 2012
August 19, 2014
April 2012
September 2015   (final data collection date for primary outcome measure)
Overall response rates (ORR) assessed by the investigator [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
Objective overall response rates (ORR) assessed by a blinded independent review committee (IRC), tumor assessment according to RECIST criteria [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01565083 on ClinicalTrials.gov Archive Site
  • Abnormal laboratory finding [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Time to progression (TTP) [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Cardiac safety: Incidence of congestive heart failure/change in LVEF [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Quality of life: EQ-5D/FACT-B questionnaires [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Overall response rate (ORR) assessed by the investigator [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Time to response assessed by IRC and investigator [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Duration of response assessed by IRC and investigator [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Time to progression (TTP) [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Cardiac safety: Incidence of congestive heart failure/change in LVEF [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Quality of life: EQ-5D/FACT-B questionnaires [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Pertuzumab in Combination With Herceptin (Trastuzumab) And Vinorelbine in First Line in Patients With Metastatic or Locally Advanced HER2-Positive Breast Cancer
A Two-cohort, Open-label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in First Line Patients With HER2-positive Advanced (Metastatic or Locally Advanced) Breast Cancer.

This two-cohort, open-label, multicenter, phase II study will assess the safety and efficacy of pertuzumab given in combination with Herceptin (trastuzumab) and vinorelbine in first line in patients with metastatic or locally advanced HER2- positive breast cancer. Patients will receive pertuzumab 840 mg and Herceptin 8 mg/kg administered sequentially as separate iv infusions on Days 1 and 2, respec tively, of Cycle 1. From Cycle 2 onwards, patients will receive pertuzumab 420 m g and Herceptin 6 mg/kg, administered either sequentially as separate iv infusio ns on Day 1 and Day 1 or 2, respectively (Cohort 1) or together in one infusion bag on Day 1 (Cohort 2) every 3 weeks. Vinorelbine will be administered at 25 m g/m2 iv on Days 2 and 9 of Cycle 1, and at 30-35 mg/m2 on Days 1 and 8 (or Days 2 and 9) of each following 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs, or withdrawal of cons ent or death.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: pertuzumab
    840 mg iv infusion Day 1 of Cycle 1, followed every 3 weeks by 420 mg iv as separate infusion on Day 1
  • Drug: trastuzumab [Herceptin]
    8 mg/kg iv infusion on Day 2 of Cycle 1, followed every 3 weeks by 6 mg/kg iv as separate infusion on Day 1 or 2
  • Drug: pertuzumab
    840 mg iv infusion Day 1 of Cycle 1, followed every 3 weeks by 420 mg iv together with trastuzumab in a single infusion bag on Day 1
  • Drug: trastuzumab [Herceptin]
    8 mg/kg iv infusion on Day 2 of Cycle 1, followed every 3 weeks by 6 mg/kg iv together with pertuzumab in a single infusion bag on Day 1
  • Drug: vinorelbine
    25 mg/m2 iv infusion on Days 2 and 9 of Cycle 1, followed by 30-35 mg/m2 on Days 1 and 8 (or Days 2 and 9) of each 3-week cycle
  • Experimental: Cohort 1 Sequential administration
    Interventions:
    • Drug: pertuzumab
    • Drug: trastuzumab [Herceptin]
    • Drug: vinorelbine
  • Experimental: Cohort 2 Single infusion admin
    Interventions:
    • Drug: pertuzumab
    • Drug: trastuzumab [Herceptin]
    • Drug: vinorelbine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
210
September 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection
  • HER2-positive as assessed by local laboratory on primary or metastatic tumor
  • At least one measurable lesion and/or non-measurable disease evaluable according to RECIST version 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Left ventricular ejection fraction (LVEF) of at least 55%
  • Life expectancy of at least 12 weeks

Exclusion Criteria:

  • Previous systemic non-hormonal anticancer therapy in the metastatic or locally advanced setting
  • Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
  • Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
  • Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrent disease of less than 6 months
  • History of persistent Grade 2 or higher (NCI-CTC Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
  • Radiographic evidence of central nervous system (CNS) metastases
  • Current peripheral neuropathy of Grade 3 or greater
  • History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
  • Serious uncontrolled concomitant disease that would contraindicate the use of any of the investigational drugs used in this study or would put the patients at high risk for treatment -related complications
  • Inadequate hematologic, liver or renal function
  • Uncontrolled hypertension or clinically significant cardiovascular disease
  • Hepatitis B, hepatitis C or HIV infection
  • Current chronic daily treatment with corticosteroids (>/= 10 mg/day methylprednisolone or equivalent), excluding inhaled steroids
Both
18 Years and older
No
Contact: Reference Study ID Number: MO27782 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Brazil,   Denmark,   France,   Germany,   Italy,   Spain
 
NCT01565083
MO27782, 2011-003308-18
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP