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. (see Contacts and Locations)
Verified August 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: August 26, 2014
Last verified: August 2014
  Purpose

This multicenter, open-label, single-arm study will evaluate the safety and tole rability of pertuzumab in combination with Herceptin (trastuzumab) and a taxane in first-line treatment in patients with metastatic or locally recurrent HER2-po sitive 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 pertuzu mab 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: pertuzumab
Drug: taxane
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 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Pertuzumab 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: taxane
docetaxel or paclitaxel or nab-paclitaxel, administered in line with the respective product information
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
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: 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 321 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: August 26, 2014
Health Authority: Finland: Ministry of Health

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

ClinicalTrials.gov processed this record on September 16, 2014