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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

Phase 3
18 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

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

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).

- Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer

- Age ≥ 18 years.

- Left ventricular ejection fraction (LVEF) ≥ 50% at baseline (within 42 days of

- 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 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

- 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

- Current peripheral neuropathy of National Cancer Institute-Common Terminology
Criteria for Adverse Events (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.

- Computed tomography (CT) or magnetic resonance imaging (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 congestive heart failure (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 human immunodeficiency virus (HIV), hepatitis B virus
(HBV), or hepatitis C virus (HCV).

- Receipt of intravenous (IV) antibiotics for infection within 14 days of

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS) Determined by an Independent Review Facility

Outcome Description:

PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause (within 18 weeks of last tumor assessment), whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions were selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, were identified as target lesions.

Outcome Time Frame:

Baseline to data cut-off (up to 3 years, 3 months)

Safety Issue:


Principal Investigator

Ru Walker, M.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

December 2013

Related Keywords:

  • Metastatic Breast Cancer
  • Herceptin
  • Breast cancer
  • MBC
  • Taxotere
  • HER2
  • HER2 positive breast cancer
  • HER2 + breast cancer
  • HER2-positive
  • HER2-positive metastatic breast cancer
  • Breast Neoplasms