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A Single Arm, Open-label Study to Evaluate the Efficacy on Tumor Response and the Safety of Bevacizumab and Trastuzumab Combination and Sequential Capecitabine in Patients With HER2 +Ive Locally Recurrent or Metastatic Breast Cancer After Early Relapse to Adjuvant Trastuzumab-containing Therapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

A Single Arm, Open-label Study to Evaluate the Efficacy on Tumor Response and the Safety of Bevacizumab and Trastuzumab Combination and Sequential Capecitabine in Patients With HER2 +Ive Locally Recurrent or Metastatic Breast Cancer After Early Relapse to Adjuvant Trastuzumab-containing Therapy


Inclusion Criteria:



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

- locally recurrent or metastatic HER2-positive breast cancer

- disease progression during or up to 12 months after prior adjuvant therapy with
trastuzumab

- LVEF >/=55% at baseline

Exclusion Criteria:

- prior treatment with bevacizumab or capecitabine

- anthracyclines in prior adjuvant or neoadjuvant treatment exceeding cumulative dose
of 360mg/m2 for doxorubicin and 720mg/kg for epirubicin

- chronic daily treatment with corticosteroids (>10mg/day methylprednisolone
equivalent; excluding inhaled corticosteroids), or aspirin (>325mg/day), or
clopidogrel (>75mg/day)

- clinically significant cardiac disease, or cardiac toxicity during previous
trastuzumab therapy

- evidence of spinal cord compression or CNS metastasis

- history of other malignancy, unless disease-free for >/=5 years or treated curatively
for carcinoma in situ of the cervix or non-melanomatous skin cancer

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-Free Survival on second-line treatment

Outcome Time Frame:

event-driven, tumour assessments every 6 weeks for 24 weeks, every 12 weeks thereafter

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

ML22056

NCT ID:

NCT00964704

Start Date:

March 2011

Completion Date:

August 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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