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Trial record 26 of 168 for:    pertuzumab

A Study to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel Versus Placebo + Trastuzumab + Docetaxel in Previously Untreated Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (MBC)

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ClinicalTrials.gov Identifier: NCT02896855
Recruitment Status : Active, not recruiting
First Posted : September 12, 2016
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial in China will evaluate the efficacy and safety of pertuzumab + trastuzumab + docetaxel compared with placebo + trastuzumab + docetaxel in participants with previously untreated HER2-positive MBC.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel Drug: Pertuzumab Drug: Placebo Drug: Trastuzumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab+Herceptin+Docetaxel Versus Placebo+Herceptin+Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
Actual Study Start Date : September 13, 2016
Actual Primary Completion Date : June 27, 2018
Estimated Study Completion Date : September 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Arm A: Placebo + Trastuzumab + Docetaxel
Placebo matched to pertuzumab, trastuzumab (8-milligrams per kilogram [mg/kg] loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-milligrams per square meter [mg/m^2]), administered by intravenous (IV) infusion every 3 weeks until disease progression or unacceptable toxicity.
Drug: Docetaxel
Docetaxel (75-mg/m^2) administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.

Drug: Placebo
Placebo matched to pertuzumab administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.

Drug: Trastuzumab
Trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles) administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
Other Name: Herceptin

Experimental: Arm B: Pertuzumab + Trastuzumab + Docetaxel
Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles), trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles), and docetaxel (75-mg/m^2), administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
Drug: Docetaxel
Docetaxel (75-mg/m^2) administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.

Drug: Pertuzumab
Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles) administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
Other Name: Perjeta

Drug: Trastuzumab
Trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles) administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
Other Name: Herceptin




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to approximately 3 years ]

Secondary Outcome Measures :
  1. Percentage of Participants With Symptomatic Left Ventricular Systolic Dysfunction, as Determined Using Echocardiography (ECHO) or Multiple-gated Acquisition (MUGA) Scan [ Time Frame: Baseline up to approximately 3 years ]
  2. Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction, as Determined Using ECHO or MUGA Scan [ Time Frame: Baseline up to approximately 3 years ]
  3. LVEF as Determined Using ECHO or MUGA Scan [ Time Frame: Baseline, every 9 weeks thereafter up to approximately 3 years ]
  4. Overall Survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to approximately 3 years ]
  5. Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to assessed up to approximately 3 years ]
  6. Duration of Objective Response as Determined by the Investigator Using RECIST v1.1 [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to assessed up to approximately 3 years ]
  7. Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease that is suitable for chemotherapy
  • HER2-positive MBC
  • Left ventricular ejection fraction (LVEF) greater than or equal to (>=) 55 percent (%) at baseline (within 42 days of randomization)
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Women of childbearing potential and men should agree to use an effective form of contraception and to continue its use for the duration of study treatment and for at least 7 months after the last dose of study treatment (trastuzumab and/or pertuzumab)

Exclusion Criteria:

  • History of anti-cancer 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 less than (<) 12 months
  • History of persistent Grade >= 2 hematologic toxicity resulting from previous adjuvant therapy
  • Grade >= 3 peripheral neuropathy at randomization
  • History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or non-melanoma skin carcinoma that has been previously treated with curative intent
  • Current clinical or radiographic evidence of central nervous system (CNS) metastases
  • History of exposure to cumulative doses of anthracyclines
  • Current uncontrolled hypertension or unstable angina
  • History of congestive heart failure (CHF) of any New York Heart Association (NYHA) classification, or serious cardiac arrhythmia requiring treatment
  • History of myocardial infarction within 6 months of randomization
  • History of LVEF decrease to < 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 human immunodeficiency virus (HIV), hepatitis C virus (HCV), or active hepatitis B virus (HBV)
  • Receipt of intravenous (IV) antibiotics for infection within 14 days of randomization
  • Current chronic daily treatment with corticosteroids (excluding inhaled steroids)
  • Known hypersensitivity to any of the protocol-specified study treatments
  • Concurrent participation in an interventional or noninterventional study

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): NCT02896855


Locations
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China
CHINESE ACADEMY OF MEDICAL SCIENCE; CANCER INST. & HOSPITAL; Medical ward
Beijing, China, 100021
Beijing Cancer Hospital
Beijing, China, 100142
Chinese PLA General Hospital
Beijing, China, 100853
the First Hospital of Jilin University
Changchun, China, 130021
Changzhou First People's Hospital
Changzhou, China, 213003
West China Hospital, Sichuan University
Chengdu, China, 610041
Fuzhou General Hospital, PLA Nanjing Military Area Command
Fuzhou, China, 110016
Guangdong General Hospital
Guangzhou, China, 510080
Zhejiang Cancer Hospital
Hangzhou, China, 310022
Harbin Medical University Cancer Hospital
Harbin, China, 150081
Shandong Cancer Hospital
Jinan, China, 250117
Jiangsu Cancer Hospital
Nanjing, China, 210009
Jiangsu province hospital; surgery on galactophore
Nanjing, China, 210029
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
First Hospital of China Medical University
Shenyang, China, 110001
Liaoning cancer Hospital & Institute
Shenyang, China, 110042
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02896855     History of Changes
Other Study ID Numbers: YO29296
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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