Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer (PERUSE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01572038
First received: April 3, 2012
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.

Condition Intervention Phase
Breast Neoplasms
Drug: Docetaxel
Drug: Nab-paclitaxel
Drug: Paclitaxel
Drug: Pertuzumab
Drug: Trastuzumab
Phase 3

Study Type: Interventional
Study Design: 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 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:
  • Percentage of Participants With AEs Leading to Study Treatment Interruption and Discontinuation [ Time Frame: Baseline up to approximately 7 years 3 months ] [ Designated as safety issue: No ]
  • Percentage of Participants who Died, Reported by Cause of Death [ Time Frame: Baseline up to approximately 7 years 3 months ] [ Designated as safety issue: No ]
  • Percentage of Participants with Congestive Heart Failure (CHF) [ Time Frame: Baseline up to approximately 7 years 3 months ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Baseline up to approximately 7 years 3 months ] [ Designated as safety issue: No ]
  • Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study [ Time Frame: Screening, every 3 cycles (cycle length=3 weeks) prior to study drug administration during treatment period, 1 month post-treatment safety follow-up (approximately 7 years 3 months overall) ] [ Designated as safety issue: Yes ]
  • Time to Onset of the First Episode of CHF [ Time Frame: Baseline up to approximately 7 years 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-Free Survival (PFS) as Assessed by Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 [ Time Frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months) ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Screening up to death due to any cause (up to approximately 7 years 3 months) ] [ Designated as safety issue: No ]
  • Percentage of Participants with Objective Response (Complete Response [CR] or Partial Response [PR]) Based on Best Confirmed Overall Response as Assessed by Investigator Based on RECIST v1.1 [ Time Frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months) ] [ Designated as safety issue: No ]
  • Percentage of Response with Clinical Benefit Response (CR, PR or Stable Disease [SD; for At Least 6 months] Based on Best Confirmed Overall Response as Assessed by Investigator Based on RECIST v.1.1 [ Time Frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months) ] [ Designated as safety issue: No ]
  • Duration of Response as Assessed by Investigator Based on RECIST v1.1 [ Time Frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months) ] [ Designated as safety issue: No ]
  • Time to Response Among Participants with Best Response of PR or CR as Assessed by Investigator Based on RECIST v1.1 [ Time Frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months) ] [ Designated as safety issue: No ]
  • Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores for Female Participants Only [ Time Frame: Screening, every 3 cycles (cycle length=3 weeks) during treatment period, 1 and 3 months post-treatment safety follow-up (approximately 7 years 3 months overall) ] [ Designated as safety issue: No ]

Enrollment: 1436
Study Start Date: June 2012
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pertuzumab + Trastuzumab + Taxane
Participants will receive pertuzumab and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first. Taxane chemotherapy can be either docetaxel, paclitaxel or nab-paclitaxel as per investigator's choice.
Drug: Docetaxel
Participants may receive 'docetaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.
Drug: Nab-paclitaxel
Participants may receive 'nab-paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.
Drug: Paclitaxel
Participants may receive 'paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.
Drug: Pertuzumab
Participants will receive pertuzumab 840 milligrams (mg) IV on Day 1 or Day 2 of Cycle 1, followed by 420 mg IV on Day 1 or Day 2 of each subsequent 3-week cycle.
Other Name: RO 43-68451
Drug: Trastuzumab
Participants will receive trastuzumab (Herceptin) 8 milligrams per kilogram (mg/kg) IV on Day 1 or Day 2 of Cycle 1, followed by 6 mg/kg IV on Day 1 or Day 2 of each subsequent 3-week cycle, administered in line with the respective product Information and/or recognized clinical practice guidelines.
Other Name: Herceptin

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • LVEF of at least 50 percent (%)

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 less than or equal to (</=) 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 (National Cancer Institute Common Toxicity Criteria [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 first 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 Human Immunodeficiency Virus (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

  Show 320 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

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: November 1, 2016
Health Authority: Finland: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Taxane
Pertuzumab
Albumin-Bound Paclitaxel
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 06, 2016