Clinical Trials /

Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer

NCT02402712

Description:

This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients are to receive study medication until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end, whichever occurs first. The anticipated time on study treatment is approximately 24 months. The target sample size is 400.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer
  • Official Title:

Clinical Trial IDs

  • ORG STUDY ID: BO29159
  • SECONDARY ID: 2014-001458-40
  • NCT ID: NCT02402712

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
DocetaxelHerceptin SC + Perjeta IV + docetaxel IV
pertuzumab [Perjeta]RO4368451Herceptin SC + Perjeta IV + docetaxel IV
trastuzumab [Herceptin]RO0452317Herceptin SC + Perjeta IV + docetaxel IV

Purpose

This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients are to receive study medication until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end, whichever occurs first. The anticipated time on study treatment is approximately 24 months. The target sample size is 400.

Trial Arms

NameTypeDescriptionInterventions
Herceptin SC + Perjeta IV + docetaxel IVExperimentalSingle arm
  • Docetaxel
  • pertuzumab [Perjeta]
  • trastuzumab [Herceptin]

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed and documented adenocarcinoma of the breast
             with metastatic or locally recurrent disease not amenable to curative resection.
             Patients with measurable and/or non-measurable disease evaluable according to Response
             Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 are eligible.

          -  HER2-positive disease (defined as either immunohistochemistry [IHC] 3 + or in situ
             hybridization [ISH] positive) as assessed by local laboratory on primary tumor or
             metastatic site if primary tumor not available

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

          -  Left ventricular ejection fraction (LVEF) of at least 50%

          -  Negative serum pregnancy test result at baseline and use of effective contraception as
             defined by the protocol

        Exclusion Criteria:

          -  Previous systemic non-hormonal anti-cancer therapy for the metastatic or locally
             recurrent disease. Note: Prior to study entry, up to two lines of hormonal therapy for
             metastatic or locally recurrent disease are permitted, one of which may be in
             combination with everolimus.

          -  Disease-free interval of less than 6 months from completion of adjuvant or neoadjuvant
             systemic non-hormonal treatment to recurrence of breast cancer

          -  Previous approved or investigative anti-HER2 agents as neoadjuvant or adjuvant therapy
             for any breast cancer treatment, except Herceptin

          -  History of persistent Grade 2 or higher hematological toxicity resulting from previous
             adjuvant or neoadjuvant therapy

          -  Radiographic evidence of central nervous system (CNS) metastases as assessed by
             computed tomography (CT) or magnetic resonance imaging (MRI), unless they have been
             treated and have been stable for at least 3 months and do not require ongoing
             corticosteroid treatment

          -  Current peripheral neuropathy of Grade 3 or greater

          -  History of other malignancy within the last 5 years prior to first dose of study drug
             administration, except for carcinoma in situ of the cervix or basal cell carcinoma

          -  Inadequate organ function

          -  Uncontrolled hypertension with or without medication

          -  Clinically significant cardiovascular disease

          -  History of LVEF decline to below 50% during or after prior Herceptin neo-adjuvant or
             adjuvant therapy

          -  Current known infection with HIV, hepatitis B virus, or hepatitis C virus

          -  Severe 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, including severe pulmonary
             conditions/illness

          -  Pregnant or lactating women

          -  Dyspnea at rest due to complications of advanced malignancy or other disease requiring
             continuous oxygen therapy

          -  History of receiving any investigational treatment within 28 days prior to first dose
             of study drug administration (dosing) or concurrent participation in any
             interventional clinical trial
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of adverse events (AEs)
Time Frame:Up to 24 months after the last patient has been enrolled, approximately 3.5 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression-free survival, tumor assessments according to RECIST v1.1
Time Frame:Up to 3.5 years
Safety Issue:
Description:
Measure:Overall survival
Time Frame:Up to 3.5 years
Safety Issue:
Description:
Measure:Objective response rate, defined as a complete response (CR) or a partial response (PR)
Time Frame:Up to 3.5 years
Safety Issue:
Description:
Measure:Incidence of anti-Herceptin, anti-rHuPH20 antibodies
Time Frame:Up to 3.5 years
Safety Issue:
Description:

Details

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

Last Updated

December 20, 2017