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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

NCT01572038

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: MO28047
  • SECONDARY ID: 2011-005334-20
  • NCT ID: NCT01572038

Conditions

  • Breast Neoplasms

Interventions

DrugSynonymsArms
DocetaxelPertuzumab + Trastuzumab + Taxane
Nab-paclitaxelPertuzumab + Trastuzumab + Taxane
PaclitaxelPertuzumab + Trastuzumab + Taxane
PertuzumabRO 43-68451Pertuzumab + Trastuzumab + Taxane
TrastuzumabHerceptinPertuzumab + Trastuzumab + Taxane

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.

Trial Arms

NameTypeDescriptionInterventions
Pertuzumab + Trastuzumab + TaxaneExperimentalParticipants 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.
  • Docetaxel
  • Nab-paclitaxel
  • Paclitaxel
  • Pertuzumab
  • Trastuzumab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of Participants With AEs Leading to Study Treatment Interruption and Discontinuation
Time Frame:Baseline up to approximately 7 years 3 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:Screening up to death due to any cause (up to approximately 7 years 3 months)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Hoffmann-La Roche

Last Updated

January 15, 2018