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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00964704

Enrollment

Registered

2009-08-25

Start date

2011-03-31

Completion date

2013-08-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DRUGbevacizumab [Avastin]

15mg/kg iv every 3 weeks

DRUGcapecitabine [Xeloda]

added at time of disease-progression, 1000mg/m2 bid po days 1-14 of every 3-week cycle

DRUGdocetaxel

background therapy at time of disease progression, 100mg/m2 iv every 3 weeks

DRUGtrastuzumab [Herceptin]

8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg every 3 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival on second-line treatment	event-driven, tumour assessments every 6 weeks for 24 weeks, every 12 weeks thereafter

Secondary

Measure	Time frame
Safety and tolerability: AEs, laboratory parameters, LVEF	throughout study, laboratory parameters every 3 weeks, LVEF every 12 weeks
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026