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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02402712
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : April 2, 2019
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 23, 2015
First Posted Date  ICMJE March 30, 2015
Last Update Posted Date April 2, 2019
Actual Study Start Date  ICMJE May 6, 2015
Actual Primary Completion Date February 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2015)
  • Incidence of adverse events (AEs) [ Time Frame: Up to 24 months after the last patient has been enrolled, approximately 3.5 years ]
  • Incidence and severity of adverse events Grade >/= 3, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 [ Time Frame: Up to 24 months after the last patient has been enrolled, approximately 3.5 years ]
  • Incidence of cardiac events (composite outcome measure): congestive heart failure (CHF) and cardiac death [ Time Frame: Up to 24 months after the last patient has been enrolled, approximately 3.5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02402712 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2015)
  • Progression-free survival, tumor assessments according to RECIST v1.1 [ Time Frame: Up to 3.5 years ]
  • Overall survival [ Time Frame: Up to 3.5 years ]
  • Objective response rate, defined as a complete response (CR) or a partial response (PR) [ Time Frame: Up to 3.5 years ]
  • Incidence of anti-Herceptin, anti-rHuPH20 antibodies [ Time Frame: Up to 3.5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE 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  ICMJE Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Docetaxel
    Intravenous administration according to local label/clinical practice, after Herceptin and Perjeta.
  • Drug: pertuzumab [Perjeta]
    Intravenous infusion every 3 weeks. First dose: 840 mg. Subsequent doses: 420 mg
    Other Name: RO4368451
  • Drug: trastuzumab [Herceptin]
    Subcutaneous administration of 600 mg/5 mL every 3 weeks
    Other Name: RO0452317
Study Arms  ICMJE Experimental: Herceptin SC + Perjeta IV + docetaxel IV
Single arm
  • Drug: Docetaxel
  • Drug: pertuzumab [Perjeta]
  • Drug: trastuzumab [Herceptin]
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2015)
Actual Study Completion Date  ICMJE February 22, 2019
Actual Primary Completion Date February 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Canada,   France,   Germany,   Hungary,   Italy,   Mexico,   Poland,   Portugal,   Spain,   United Kingdom
Removed Location Countries Romania
Administrative Information
NCT Number  ICMJE NCT02402712
Other Study ID Numbers  ICMJE BO29159
2014-001458-40 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP