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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.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01565083
First received: March 26, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Day 1 of Cycle 1. From Cycle 2 onwards, patients will receive pertuzumab 420 mg and Herceptin 6 mg/kg, administered either sequentially as separate iv infusions (Cohort 1) or together in one infusion bag (Cohort 2) every 3 weeks. Vinorelbine will be administered at 25 mg/m2 iv on Days 1 and 8 of Cycle 1, and at 30-35 mg/m2 on Days 1 and 8 of each following 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs, or withdrawal of consent or death.


Condition Intervention Phase
Breast Cancer
 Drug: pertuzumab
Drug: trastuzumab [Herceptin]
Drug: vinorelbine
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 210
Study Start Date: April 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Sequential administration Drug: pertuzumab
840 mg iv infusion Day 1 of Cycle 1, followed every 3 weeks by 420 mg iv as separate infusion
Drug: trastuzumab [Herceptin]
8 mg/kg iv infusion on Day 1 of Cycle 1, followed every 3 weeks by 6 mg/kg iv as separate infusion
Drug: vinorelbine
25 mg/m2 iv infusion on Days 1 and 8 of Cycle 1, followed by 30-35 mg/m2 on Days 1 and 8 of each 3-week cycle
Experimental: Cohort 2 Single infusion admin 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
Drug: trastuzumab [Herceptin]
8 mg/kg iv infusion on Day 1 of Cycle 1, followed every 3 weeks by 6 mg/kg iv together with pertuzumab in a single infusion bag
Drug: vinorelbine
25 mg/m2 iv infusion on Days 1 and 8 of Cycle 1, followed by 30-35 mg/m2 on Days 1 and 8 of each 3-week cycle

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565083

Contacts
Contact: Please reference Study ID Number: MO27782 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 82 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01565083     History of Changes
Other Study ID Numbers: MO27782, 2011-003308-18
Study First Received: March 26, 2012
Last Updated: May 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vinorelbine
 Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013