A Randomized Study to Determine the Efficacy of a Taxane & Bevacizumab

Status Terminated

Clinical Trial Summary

The purpose of this study is to determine whether

- Paclitaxel and bevacizumab showed improved PFS compared to paclitaxel alone. Recent results of the AVADO study report a similar result for the combination of docetaxel and bevacizumab. The AVADO study furthermore confirmed the dose of 15 mg/kg BW of bevacizumab.

- As in metastatic breast cancer (MBC) poly-chemotherapies are frequently used, regimens with bevacizumab and at least 2 cytotoxic agents should be investigated.

- Docetaxel and capecitabine showed a benefit in PFS and survival. This combi- nation is therefore a reasonable choice.

- Dose of capecitabine and docetaxel should be reduced to 1800 mg/m2 and 75 mg/m2 to improve tolerability without compromising efficacy.

- Paclitaxel and capecitabine is well tolerated and showed a PFS of 10.3 months.

- Docetaxel 100 mg/m2 as monotherapy in MBC not very often used b/o toxicity. 75 mg/m2 much more accepted in daily practice. Better comparability with DBX, if both arms have 75mg/m2 docetaxel as assumed.

Clinical Trial Description

Primary Objective:

- To determine the Progression Free Survival (PFS) in patients with metastatic breast cancer after treatment with taxane plus bevacizumab with (TXB) or without capecitabine (TB).

Secondary Objective(s):

- To determine the objective response rate in both arms.

- To determine the duration of response in both arms.

- To determine the Time to Progression (TTP) in both arms.

- To determine the clinical benefit defined as CR, PR, or stable disease ≥ 24 weeks in both arms.

- To determine the overall survival rate 3 years after "Last Patient In".

- To determine PFS and TTP response rates in patient's ≥ age 65.

- To determine the toxicity and compliance in both arms.

- To determine the predictive value of serum markers such as VEGF. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01200212
Study type	Interventional
Source	German Breast Group
Contact
Status	Terminated
Phase	Phase 3
Start date	July 2009
Completion date	October 2012

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Randomized Study to Determine the Efficacy of a Taxane and Bevacizumab With or Without Capecitabine as First Line Chemotherapy in Patients With Metastatic Breast Cancer — TABEA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms