Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2011-005334-20-ES
EUCTR2011-005334-20-ESActive, not recruitingPhase 1

A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancer - PERUSE

F. Hoffmann-La Roche Ltd.0 sites1,500 target enrollmentStarted: February 22, 2012Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
1,500
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Signed written informed consent approved by the relevant Institutional Review Board (IRB), or Independent Ethics Committee (IEC).
  • •2. Male or female patients aged 18 years or over.
  • •3. Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection.
  • •4. HER2-positive (defined as either IHC 3+ or in situ hybridization [ISH] positive) as assessed by local laboratory on primary tumor and/or metastatic site if primary tumor not available (ISH positivity is defined as a ratio of 2.0 or greater for the number of HER2 gene copies to the number of signals for CEP17, or for single probe tests, a HER2 gene count greater than 4).
  • •5. At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Appendix 5).
  • •6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (Appendix 3).
  • •7. LVEF of at least 50%.
  • •8. Negative serum pregnancy test in women of childbearing potential (WOCBP; premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization).
  • •9. For WOCBP and male patients with partners of CBP who are sexually active, agreement to use a highly effective, non-hormonal form of contraception (such as surgical sterilization) or two effective forms of non-hormonal contraception (such as a barrier method of contraception in conjunction with spermicidal jelly) during and for at least 6 months post-study treatment (refer to Section 4.5.2.1 for details).
  • •10. Life expectancy of at least 12 weeks.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 1260
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

  • •1. Previous systemic non-hormonal anticancer therapy for the metastatic or locally recurrent disease.
  • •2. Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence within 6 months.
  • •3. Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting.
  • •4. Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting.
  • •5. History of persistent Grade 2 or higher (National Cancer Institute [NCI]-Common Toxicity Criteria [CTC], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy.
  • •6. Radiographic evidence of central nervous system (CNS) metastases as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
  • •7. Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, Version 4.0).
  • •8. History of other malignancy within the last 5 years prior to 1st study drug administration (dosing), except for carcinoma in situ of the cervix or basal cell carcinoma.
  • •9. Serious uncontrolled concomitant disease that would contraindicate the use of any of the investigational drugs used in this study or that would put the patient at high risk for treatment-related complications.
  • •10. Inadequate organ function, evidenced by the following laboratory results:
  • •?Absolute neutrophil count <1,500 cells/mm3
  • •?Platelet count <100,000 cells/mm3
  • •?Hemoglobin <9 g/dL
  • •?Total bilirubin greater than the upper limit of normal (ULN; unless the patient has documented Gilbert?s syndrome)
  • •?Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) >2.5 × ULN (> 5 × ULN in patients with liver metastases)
  • •?Alkaline phosphatase levels > 2.5 × the ULN (> 5 × ULN in patients with liver metastases, or >10 × ULN in patients with bone metastases)
  • •?Serum creatinine >2.0 mg/dL or 177 ?mol/L
  • •?International normalized ratio (INR) and activated partial thromboplastin time or partial thromboplastin time (aPTT or PTT) >1.5 × ULN (unless on therapeutic anti-coagulation).
  • •11. Uncontrolled hypertension (systolic >150 m m Hg and/or
  • •diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) Grade II or higher, or serious cardiac arrhythmia requiring medication.
  • •12. Current known infection with HIV, Hepatitis B virus, or Hepatitis C virus.
  • •13. Dyspnea at rest due to complications of advanced malignancy, or other disease requiring continuous oxygen therapy.
  • •14. Major surgical procedure or significant traumatic injury within 28 days prior to 1st study drug administration (dosing) or anticipation of need for major surgery during the course of study treatment.
  • •15. Receipt of intravenous antibiotics for infection within 14 days prior to enrolment.
  • •16. Current chronic daily treatment with corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids.
  • •17. Known hypersensitivity to any of the study medications or to excipients of recombinant human or humanized antibodies.
  • •18. History of receiving any investigational treatment within 28 days prior to 1st study drug administration (dosing).
  • •19. Assessed by the Investigator to be unable or unwilling to comply with the requirements of t

Investigators

Similar Trials

Active, not recruiting
Phase 1
A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancer
EUCTR2011-005334-20-GRF. Hoffmann-La Roche Ltd.1,500
Active, not recruiting
Phase 1
A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancerAdvanced breast cancer (metastatic or locally recurrent)MedDRA version: 20.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2011-005334-20-EEF. Hoffmann-La Roche Ltd.1,500
Active, not recruiting
Phase 1
A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancerAdvanced breast cancer (metastatic or locally recurrent)MedDRA version: 20.0 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2011-005334-20-GBF. Hoffmann-La Roche Ltd.1,500
Active, not recruiting
Phase 1
A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancerAdvanced breast cancer (metastatic or locally recurrent)MedDRA version: 20.0 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2011-005334-20-LTF. Hoffmann-La Roche Ltd.1,500
Active, not recruiting
Phase 1
A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancerAdvanced breast cancer (metastatic or locally recurrent)MedDRA version: 19.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2011-005334-20-NLF. Hoffmann-La Roche Ltd.1,436