Clinical trial NCT00964704: A Study of Herceptin (Trastuzumab) in Combination With Avastin (Bevacizumab) and Sequential Xeloda (Capecitabine) or Docetaxel in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm, open-label study will evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive breast cancer after early relapse on adjuvant Herceptin therapy. Patients will receive Herceptin at a loading dose of 8mg/kg iv followed by 6mg/kg iv every three weeks, and Avastin 15mg/kg every 3 weeks. At first sign of disease progression Xeloda 1000mg/m2 bid po will be added on days 1-14 of each cycle, or docetaxel (100mg/m2 iv every 3 weeks) if Xeloda is not indicated for a patient. Anticipated time on study treatment is until disease-progression on second line treatment and target sample size is \<100.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free Survival on second-line treatment
timeFrame: event-driven, tumour assessments every 6 weeks for 24 weeks, every 12 weeks thereafter
Secondary outcomes:
measure: Safety and tolerability: AEs, laboratory parameters, LVEF
timeFrame: throughout study, laboratory parameters every 3 weeks, LVEF every 12 weeks
measure: Overall Response Rate, Best Overall Response, Duration of Response, Progression-free Survival (first-line), Overall Survival
timeFrame: event-driven, tumour assessment every 6 weeks for 24 weeks, every 12 weeks thereafter
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: