Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Perjeta (Pertuzumab) and Herceptin (Trastuzumab) Treatment in Combination With a Taxane in Patients With Advanced HER2-positive Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: December 18, 2013
Last updated: February 23, 2015
Last verified: February 2015

December 18, 2013
February 23, 2015
December 2013
May 2017   (final data collection date for primary outcome measure)
  • Incidence of adverse events (AEs) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Incidence of serious AEs [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Evidence of cardiac dysfunction as measured by decreases in left ventricular ejection fraction (LVEF). [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT02019277 on Archive Site
  • Overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Progression-free survival assessed according to RECIST version 1.1 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Event-free survival assessed according to RECIST version 1.1 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
A Study of Perjeta (Pertuzumab) and Herceptin (Trastuzumab) Treatment in Combination With a Taxane in Patients With Advanced HER2-positive Breast Cancer
An Open-label, Multicentre, Phase IIIb Study With Intravenous Administration of Pertuzumab, Subcutaneous Trastuzumab, and a Taxane in Patients With HER2-positive Metastatic Breast Cancer

This open-label, phase III study will assess the safety, tolerability and efficacy of a combination therapy of intravenous (IV) Perjeta, subcutaneous (SC) Herceptin, and taxane chemotherapy (docetaxel, paclitaxel or nab-paclitaxel) as first-line therapy in patients with HER2-positive metastatic breast cancer. All patients will be treated with 3-week cycles of Perjeta IV (840 mg first dose; subsequent doses of 420 mg) and trastuzumab SC (600 mg/5 mL). The taxane treatment regimen will determined by the investigator. Patients will continue therapy until disease progression, unacceptable toxicity, or the patient withdraws consent, whicever occurs first. Time on study treatment is up to 2 years.

Not Provided
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Herceptin (trastuzumab)
    Subcutaneous administration of 600 mg/5 mL every 3 weeks.
  • Drug: Perjeta (pertuzumab)
    Intravenous infusion every 3 weeks. First dose: 840 mg. Subsequent doses: 420 mg
  • Drug: Taxane chemotherapy
    Administration of docetaxel, paclitaxel, or nab-paclitaxel. Dosing regimen to be determined by the investigator.
Experimental: pertuzumab [Perjeta], trastuzumab [Herceptin], and taxane
  • Drug: Herceptin (trastuzumab)
  • Drug: Perjeta (pertuzumab)
  • Drug: Taxane chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2017
May 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female and male patients aged >/= 18 years
  • HER2-positive disease, with an immunohistochemistry score of 3+ or ISH-positive on primary tumour or metastatic site
  • Histologically or cytologically confirmed metastatic breast cancer (mBC) with at least one measurable lesion and/or non-measurable disease according to RECIST version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 for patients who will receive paclitaxel or nab-paclitaxel chemotherapy and ECOG 0-1 for patients who will receive docetaxel chemotherapy
  • LVEF of >/= 50% measured by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan before the first doses of pertuzumab and trastuzumab.
  • Previous use of either adjuvant or neoadjuvant anti-HER2 therapy is allowed
  • Hormonal therapy will be allowed as per institutional guidelines (administered after completion of taxane chemotherapy)
  • Use of effective contraception as defined by the protocol

Exclusion Criteria:

  • Previous systemic non-hormonal anticancer therapy for treatment of mBC
  • History of other cancers. Patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and patients with other curatively-treated cancers who have been disease-free for at least 5 years are eligible. Patients with previous ductal carcinoma in situ (DCIS) of the breast are also eligible for the study
  • Pregnant or lactating women
  • Current peripheral neuropathy of Grade 3 or greater (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0)
  • 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
  • Patients with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
  • Inadequate organ function
  • Serious cardiac illness or medical conditions that would preclude the use of trastuzumab
  • Patients with severe breathing difficulties at rest or requiring supplementary oxygen therapy
  • Concurrent enrolment in another clinical study using an investigational anti-cancer treatment, within 28 days before the first doses of Herceptin and Perjeta
18 Years and older
Contact: Reference Study ID Number: ML28784 888-662-6728 (U.S. Only)
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
February 2015

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