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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00964704
• Other study ID #: ML22056
• Secondary ID: 2008-007495-20
• Status: Withdrawn
• Phase: Phase 2
• First received: August 21, 2009
• Last updated: November 1, 2016
• Start date: March 2011
• Est. completion date: August 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• bevacizumab [Avastin]
15mg/kg iv every 3 weeks
• capecitabine [Xeloda]
added at time of disease-progression, 1000mg/m2 bid po days 1-14 of every 3-week cycle
• docetaxel
background therapy at time of disease progression, 100mg/m2 iv every 3 weeks
• trastuzumab [Herceptin]
8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival on second-line treatment		event-driven, tumour assessments every 6 weeks for 24 weeks, every 12 weeks thereafter	No
Secondary	Safety and tolerability: AEs, laboratory parameters, LVEF		throughout study, laboratory parameters every 3 weeks, LVEF every 12 weeks	No
Secondary	Overall Response Rate, Best Overall Response, Duration of Response, Progression-free Survival (first-line), Overall Survival		event-driven, tumour assessment every 6 weeks for 24 weeks, every 12 weeks thereafter	No