A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated Her2-Positive Metastatic Breast Cancer (CLEOPATRA) - Full Text View

Sponsor:	Genentech
Collaborator:	Roche Pharma AG
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00567190

Purpose

This study is a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial. Patients who have HER2-positive MBC and have not received chemotherapy or biologic therapy (including approved or investigational tyrosine kinase/ HER inhibitors or vaccines) for their metastatic disease are eligible for study. Patients could have received one prior hormonal treatment for MBC. Patients may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the patient has experienced a DFI of ≥ 12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Patients may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: docetaxel Drug: pertuzumab Drug: placebo Drug: trastuzumab	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated Her2-Positive Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Trastuzumab Pertuzumab

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

Progression-free survival based on independent review facility (IRF) evaluation [ Time Frame: Time from randomization to progressive disease (PD) as determined by the IRF or death, whichever occurs first ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: Time from the date of randomization to the date of death ] [ Designated as safety issue: No ]
Incidence of congestive heart failure (CHF) and asymptomatic left ventricular ejection fraction (LVEF) events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: Yes ]
LVEF measurements over the course of the study [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: Yes ]
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	December 2007
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: docetaxel IV repeating dose Drug: pertuzumab IV repeating dose Drug: trastuzumab IV repeating dose
2: Placebo Comparator	Drug: docetaxel IV repeating dose Drug: placebo IV repeating dose Drug: trastuzumab IV repeating dose

Eligibility

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

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and candidate for chemotherapy. Patients with measurable and non-measurable disease are eligible (locally recurrent disease must not be amenable to resection with curative intent; patients with de-novo Stage IV disease are eligible)
HER2-positive metastatic breast cancer (MBC)
Age ≥ 18 years
Left Ventricular Ejection Fraction (LVEF) ≥ 50% at baseline (within 42 days of randomization)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
For women of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of study treatment and for 6 months after the last dose of study treatment
Signed, written informed consent obtained prior to any study procedure

Exclusion Criteria:

History of anticancer therapy for MBC (with the exception of one prior hormonal regimen for MBC)
History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant setting
History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting with a disease-free interval from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of < 12 months
History of persistent Grade ≥ 2 hematologic toxicity resulting from previous adjuvant therapy
Current peripheral neuropathy of NCI-CTCAE, Version 3.0, Grade ≥ 3 at randomization
History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
Current clinical or radiographic evidence of central nervous system (CNS) metastases
CT or MRI scan of the brain is mandatory in cases of clinical suspicion of brain metastases
History of exposure to cumulative doses of anthracyclines
Current uncontrolled hypertension or unstable angina
History of CHF of any New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment
History of myocardial infarction within 6 months of randomization
History of LVEF decline to below 50% during or after prior trastuzumab neo-adjuvant or adjuvant therapy
Current dyspnea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy
Inadequate organ function within 28 days prior to randomization
Current severe, uncontrolled systemic disease
Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment
Pregnant or lactating women
History of receiving any investigational treatment within 28 days of randomization
Current known infection with HIV, HBV, or HCV
Receipt of IV antibiotics for infection within 14 days of randomization
Current chronic daily treatment with corticosteroids (excluding inhaled steroids)
Known hypersensitivity to any of the study drugs
Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567190

Contacts

Contact: Trial Information Support Line

888-662-6728 ext 4

Show 74 Study Locations

Sponsors and Collaborators

Genentech

Roche Pharma AG

Investigators

Study Director:

Melissa Brammer, M.D.

Genentech

More Information

Additional Information:

Ex-U.S. Study Information (Ex-US this trial is sponsored/managed by Hoffmann-La Roche) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Genentech, Inc. ( Virginia Paton, Pharm.D., Study Director )
Study ID Numbers:	TOC4129g, WO20698
Study First Received:	December 3, 2007
Last Updated:	January 22, 2010
ClinicalTrials.gov Identifier:	NCT00567190 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Herceptin
Breast Cancer
MBC
Taxotere
HER2

HER2 Positive Breast Cancer
HER2 + Breast Cancer
HER2-Positive
Her2-Positive Metastatic Breast Cancer

Additional relevant MeSH terms:

Docetaxel
Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents

Therapeutic Uses
Trastuzumab
Breast Neoplasms
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010