Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 November 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: November 24, 2014
Last verified: November 2014
  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 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.


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:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall response rates (ORR) assessed by the investigator [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 210
Study Start Date: April 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (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 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: 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 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 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

  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
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: NCT01565083

Contacts
Contact: Reference Study ID Number: MO27782 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 80 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: November 24, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on November 25, 2014