Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT02402712
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel Drug: pertuzumab [Perjeta] Drug: trastuzumab [Herceptin] Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 418 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : May 6, 2015
Actual Primary Completion Date : February 22, 2019
Actual Study Completion Date : February 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Herceptin SC + Perjeta IV + docetaxel IV
Single arm
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




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Up to 24 months after the last patient has been enrolled, approximately 3.5 years ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. Progression-free survival, tumor assessments according to RECIST v1.1 [ Time Frame: Up to 3.5 years ]
  2. Overall survival [ Time Frame: Up to 3.5 years ]
  3. Objective response rate, defined as a complete response (CR) or a partial response (PR) [ Time Frame: Up to 3.5 years ]
  4. Incidence of anti-Herceptin, anti-rHuPH20 antibodies [ Time Frame: Up to 3.5 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402712


  Show 112 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02402712     History of Changes
Other Study ID Numbers: BO29159
2014-001458-40 ( EudraCT Number )
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Trastuzumab
Pertuzumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological