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A Multicenter, Open-label, Single-arm Study of a Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2- Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

A Multicenter, Open-label, Single-arm Study of a Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2- Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer


Inclusion Criteria:



- Adult male or female patients, >/= 18 years of age

- Histologically or cytologically confirmed adenocarcinoma of the breast with
metastatic or locally recurrent disease not amenable to curative resection

- HER2-positive breast cancer

- Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2

- Left ventricular ejection fraction (LVEF) of at least 50%

Exclusion Criteria:

- Previous systemic non-hormonal anti-cancer therapy for metastatic or locally
recurrent disease

- Disease-free interval from completion of adjuvant or neoadjuvant systemic
non-hormonal treatment to recurrence
- Previous approved or investigative anti-HER2 agents in any breast cancer treatment
setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant
setting

- Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or
neoadjuvant setting

- History of persistent Grade 2 or higher (NCI-CTC, Version 4.0) hematological toxicity
resulting from previous adjuvant or neoadjuvant therapy

- Central nervous system (CNS) metastases

- Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0)

- History of other malignancy within the last 5 years prior to 1st study drug
administration, except for carcinoma in situ of the cervix or basal cell carcinoma

- Inadequate bone marrow, liver or renal function

- Uncontrolled hypertension

- Hepatitis B, hepatitis C or HIV infection

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety: Incidence of adverse events

Outcome Time Frame:

approximately 4 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Finland: Ministry of Health

Study ID:

MO28047

NCT ID:

NCT01572038

Start Date:

June 2012

Completion Date:

May 2016

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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