A Study of Pertuzumab in Combination With Herceptin (Trastuzumab) and A Taxane in First-Line Treatment in Patients With HER2-Positive Advanced Breast Cancer (PERUSE)

This study is currently recruiting participants.
Verified April 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01572038
First received: April 3, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

This multicenter, open-label, single-arm study will evaluate the safety and tolerability of pertuzumab in combination with Herceptin (trastuzumab) and a taxane in first-line treatment in patients with metastatic or locally recurrent HER2-positive breast cancer. Patients will receive pertuzumab 840 mg intravenously (iv) and Herceptin 8 mg/kg iv plus a taxane on Day 1 of Cycle 1, followed by pertuzumab 420 mg iv and Herceptin 6 mg/kg iv plus a taxane on Day 1 of each subsequent 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Condition Intervention Phase
Breast Cancer
Drug: taxane
Drug: pertuzumab
Drug: trastuzumab [Herceptin]
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Single-arm Study of a Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2- Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival, tumor assessments according to RECIST version1.1 criteria [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Overall response rate (partial response plus complete response) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Clinical benefit rate (partial response or complete response or stable disease for >/= 6 months) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Time to response (patients with best response of partial response or complete response) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Quality of life: Functional Assessment of Cancer Therapy-Breast [FACT-B] questionnaire (female patients only) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: June 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Pertuzumab Drug: taxane
docetaxel or paclitaxel or nab-paclitaxel, administered in line with the respective product information
Drug: pertuzumab
840 mg iv on Day 1 of Cycle 1, followed by 420 mg iv on Day 1 of each subsequent 3-week cycle
Drug: trastuzumab [Herceptin]
8 mg/kg iv on Day 1 of Cycle 1, followed by 6 mg/kg iv on Day 1 of each subsequent 3-week cycle, administered in line with the product information

  Eligibility

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

Inclusion Criteria:

  • Adult male or female patients, >/= 18 years of age
  • Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection
  • HER2-positive breast cancer
  • Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Left ventricular ejection fraction (LVEF) of at least 50%

Exclusion Criteria:

  • Previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease
  • Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence </= 6 months
  • Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
  • Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
  • History of persistent Grade 2 or higher (NCI-CTC, Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
  • Central nervous system (CNS) metastases
  • Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0)
  • History of other malignancy within the last 5 years prior to 1st study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma
  • Inadequate bone marrow, liver or renal function
  • Uncontrolled hypertension
  • Hepatitis B, hepatitis C or HIV infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572038

Contacts
Contact: Reference Study ID Number: MO28047 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 327 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: NCT01572038     History of Changes
Other Study ID Numbers: MO28047, 2011-005334-20
Study First Received: April 3, 2012
Last Updated: April 14, 2014
Health Authority: Finland: Ministry of Health

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

ClinicalTrials.gov processed this record on April 17, 2014