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 March 2015 by Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: December 18, 2013
Last updated: March 2, 2015
Last verified: March 2015

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.

Condition Intervention Phase
Breast Cancer
Drug: Herceptin (trastuzumab)
Drug: Perjeta (pertuzumab)
Drug: Taxane chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pertuzumab [Perjeta], trastuzumab [Herceptin], and taxane 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02019277

Contact: Reference Study ID Number: ML28784 888-662-6728 (U.S. Only)

Australia, New South Wales
Active, not recruiting
Port Macquarie, New South Wales, Australia, 2444
Active, not recruiting
Sydney, New South Wales, Australia, 2217
Active, not recruiting
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Active, not recruiting
South Brisbane, Queensland, Australia, 4101
Active, not recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Active, not recruiting
Adelaide, South Australia, Australia, 5112
Australia, Tasmania
Active, not recruiting
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Bendigo, Victoria, Australia, 3550
Active, not recruiting
East Bentleigh, Victoria, Australia, VIC 3165
Active, not recruiting
Geelong, Victoria, Australia, 3220
Active, not recruiting
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Murdoch, Western Australia, Australia, 6150
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT02019277     History of Changes
Other Study ID Numbers: ML28784
Study First Received: December 18, 2013
Last Updated: March 2, 2015
Health Authority: Australia: Therapeutic Goods Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on March 02, 2015