Who is sponsoring NCT00811135?

NCT00811135 is sponsored by Hoffmann-La Roche.

What condition does NCT00811135 study?

NCT00811135 studies Breast Cancer.

What drugs are being tested in NCT00811135?

Interventions: bevacizumab [Avastin], capecitabine [Xeloda], trastuzumab [Herceptin].

What is the status of NCT00811135?

NCT00811135 is currently COMPLETED.

Last reviewed 2016-08-23 · How we verify

A Single Arm Open-label, Phase II Study of Bevacizumab in Combination With Trastuzumab and Capecitabine as First-line Treatment of Patients With HER2-positive Locally Recurrent or Metastatic Breast Cancer

NCT00811135 Phase 2 COMPLETED Results posted

This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Details

Lead sponsor	Hoffmann-La Roche
Phase	Phase 2
Status	COMPLETED
Enrolment	88
Start date	2008-12
Completion	2015-12

Conditions

Breast Cancer

Interventions

bevacizumab [Avastin]
capecitabine [Xeloda]
trastuzumab [Herceptin]

Primary outcomes

Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) — Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0. BOR was defined as the best response recorded for a participant from the start of treatment until disease progression/recurrence. Percentage of participants with a BOR of confirmed CR or PR (responders) was reported. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Confirmed responses were those which were confirmed by a repeat assessment, performed 4 weeks after the criteria for response first met.

Countries

Denmark, France, Russia, Slovakia, Spain, Sweden