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A Two-cohort, Open-label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in First Line Patients With HER2-positive Advanced (Metastatic or Locally Advanced) Breast Cancer.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

A Two-cohort, Open-label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in First Line Patients With HER2-positive Advanced (Metastatic or Locally Advanced) Breast Cancer.


Inclusion Criteria:



- Adult patients, >/= 18 years of age

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

- HER2-positive as assessed by local laboratory on primary or metastatic tumor

- At least one measurable lesion and/or non-measurable disease evaluable according to
RECIST version 1.1 criteria

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Left ventricular ejection fraction (LVEF) of at least 55%

- Life expectancy of at least 12 weeks

Exclusion Criteria:

- Previous systemic non-hormonal anticancer therapy in the metastatic or locally
advanced setting

- Previous approved or investigative anti-HER2 agents in any breast cancer treatment
setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting

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

- Disease-free interval from completion of adjuvant or neoadjuvant systemic
non-hormonal treatment to recurrent disease of less than 6 months

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

- Radiographic evidence of central nervous system (CNS) metastases

- Current peripheral neuropathy of Grade 3 or greater

- History of other malignancy within the last 5 years, except for carcinoma in situ of
the cervix or basal cell carcinoma

- Serious uncontrolled concomitant disease that would contraindicate the use of any of
the investigational drugs used in this study or would put the patients at high risk
for treatment -related complications

- Inadequate hematologic, liver or renal function

- Uncontrolled hypertension or clinically significant cardiovascular disease

- Hepatitis B, hepatitis C or HIV infection

- Current chronic daily treatment with corticosteroids (>/= 10 mg/day
methylprednisolone or equivalent), excluding inhaled steroids

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective overall response rates (ORR) assessed by a blinded independent review committee (IRC), tumor assessment according to RECIST criteria

Outcome Time Frame:

approximately 3.5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

MO27782

NCT ID:

NCT01565083

Start Date:

April 2012

Completion Date:

December 2016

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Albany, Georgia  31701
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Cleveland, Ohio  44195
Austin, Texas  78705
Seattle, Washington  98195
McLean, Virginia  22101
Hackensack, New Jersey  07601
Denver, Colorado  
Boston, Massachusetts  
Charlotte, North Carolina  
Salt Lake City, Utah  84112