Navigation Links
Second Phase III Study of Avastin in 1st Line Metastatic Breast Cancer Meets its Primary Endpoint
Date:2/12/2008

- Results of This Trial Further Confirm the Benefit Avastin Brings to

Patients With Breast Cancer.

BASEL, Switzerland, Feb. 13 /PRNewswire/ -- Roche announced today that a phase III study in metastatic breast cancer investigating Avastin (bevacizumab) in combination with docetaxel chemotherapy compared to docetaxel alone, met its primary endpoint of improving the time patients live without their disease advancing.

The findings come from the first analysis of the phase III "Avastin and Docetaxel" ("AVADO", BO17708) study which investigated the addition of docetaxel to Avastin administered either at 7.5 or 15 mg/kg every 3 weeks. Both doses of Avastin in combination with chemotherapy showed statistically significant improvements in the time patients live without their disease advancing, as measured by progression-free survival, compared to chemotherapy alone. The study was not designed to compare the two Avastin-containing arms.

No new safety signals related to Avastin were observed in the trial.

Dr David Miles, medical oncologist, Mount Vernon Hospital, UK and principal investigator of AVADO, welcomed the news: "Each year more than one million women are diagnosed with breast cancer leading to over 400,000 deaths globally. This study confirms Avastin's effect of prolonging the time in which patients live without their disease getting worse in combination with a widely used chemotherapy partner -- this time gained is very precious."

The efficacy and safety data of AVADO will be presented at an upcoming medical meeting.

This second positive phase III trial follows the recently published landmark E2100 study, which formed the basis of European Commission approval of Avastin in combination with paclitaxel for the 1st line treatment of metastatic breast cancer in March 2007. Study E2100 showed that the addition of Avastin to paclitaxel resulted in a doubling of progression-free survival compared to paclitaxel alone.

About the BO17708 study

BO17708 is an international phase III trial which randomized 736 patients who did not receive previous chemotherapy for their metastatic breast cancer to one of three groups;

-- Avastin 7.5 mg/kg every 3 weeks in combination with docetaxel

-- Avastin 15 mg/kg every 3 weeks in combination with docetaxel

-- docetaxel + placebo as control arm

The primary objective of the study was to demonstrate superiority in progression-free survival of both Avastin containing treatment arms compared to the control arm. Secondary endpoints for the study included overall survival, response rate, duration of response, quality of life, safety and tolerability.

About Avastin

Data from the comprehensive Avastin cancer clinical development programme have resulted in approvals in advanced colorectal, breast, lung, and kidney cancer:

-- February 2004 (US) and January 2005 (EU) -- first-line treatment in

patients with metastatic colorectal cancer (CRC).

-- June 2006 (US) -- second-line treatment in patients with metastatic

CRC.

-- October 2006 (US) -- first-line treatment in patients with advanced

non-small cell lung cancer (NSCLC).

-- March 2007 (EU) -- first-line treatment in patients with metastatic

breast cancer.

-- April 2007 (Japan) -- treatment in patients with recurrent or advanced

CRC.

-- August 2007 (EU) -- first-line treatment in patients with advanced

NSCLC.

-- December 2007 (EU) -- first-line treatment in patients with advanced

RCC.

-- January 2008 (EU) -- first and later-line treatment in patients with

metastatic CRC in combination with any chemotherapy.

All trademarks used or mentioned in this release are legally protected.

Additional information

To access video clips about Avastin, in broadcast standard, free of charge, please go to: http://www.thenewsmarket.com.


'/>"/>
SOURCE Roche
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Peregrine Pharmaceuticals Receives Approval to Conduct a Second Phase II Trial of Bavituximab in Patients With Advanced Breast Cancer
2. Genaera Begins Dosing Second Phase 1 Trial of Type 2 Diabetes and Obesity Compound Trodusquemine (MSI-1436)
3. Kosan Initiates Phase 2 Trial of Alvespimycin, Second-Generation Hsp90 Inhibitor, in HER2-Positive Metastatic Breast Cancer
4. Second Thoughts about Fluoride, Reports Scientific American
5. NicOx Completes Enrollment in Second Pivotal Phase 3 Study for Naproxcinod and Provides Development Update
6. Cethromycin Achieves All Endpoints in Second Pivotal Phase III Trial for Treatment of Pneumonia
7. Pharmions Amrubicin Shows Encouraging Results Compared to Standard of Care in Second Line Treatment of Small Cell Lung Cancer
8. Immtech Reports Fiscal Second Quarter 2008 Results
9. BiPar Announces Preclinical Data Demonstrating Anti-Tumor Activity With BSI-401, Its Second-Generation PARP Inhibitor
10. Rcadias COR Analyzer Family of Products Receives Second FDA Clearance
11. Tengion Launches Second Phase 2 Clinical Trial of Regenerated Human Organ
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... -- MedDay, a biotechnology company focused on the ... entitled "High doses of biotin in progressive multiple sclerosis: extension ... Professor Ayman Tourbah , Principal Investigator of the Phase ... of Neurology (EAN) in Copenhagen, Denmark . ... place on Sunday, 29 May 2016 from 14:45 to 16:15 ...
(Date:5/24/2016)... 2016 Niederländische Chirurgen haben ... es Ärzten erlaubt, ihre Expertise weltweit zu teilen ... Live Streaming mit einer Instant-Messaging-Funktion und der Möglichkeit, ... in Europa, Afrika, Asien und den ... Plattform registriert. Information und Weiterbildung   ...
(Date:5/24/2016)...   , Study met both ... superiority in , Excellent plus Good ... of the ascending colon   , ... today announced new positive data from the phase III MORA study ... 2 litre PEG with ascorbate. The study met both primary endpoints ...
Breaking Medicine Technology:
(Date:5/27/2016)... SC (PRWEB) , ... May 27, 2016 , ... ... a line of classic American timber frame barn kits, which can be found on ... are inspired by historic American barn plans, and they highlight the craftsmanship of timber ...
(Date:5/27/2016)... ... ... An influential resource amongst nurses and professionals in the health care world, ... of topics detailing why we appreciate nurses in so many different ways. From exclusive ... being in a major recession to one of the hottest growing professions in any ...
(Date:5/27/2016)... ... May 27, 2016 , ... An ... bolstered by inspiring human-interest stories, courtesy of awareness-driven celebrities and thought leaders. It ... leading advocates, associations and industry leaders such as Bioness. , As patients ...
(Date:5/27/2016)... , ... May 27, 2016 , ... ... installment is bolstered by inspiring human interest stories, courtesy of leaders in the ... and tech within the industry, from leading advocates and associations—namely Jones & Bartlett ...
(Date:5/27/2016)... ... May 27, 2016 , ... ... the pharmaceutical, medical and food industries. Aside from its GMP accreditation, Validation Center ... proof of successfully certified products, services and staff. , Validation Center is ISO17025 ...
Breaking Medicine News(10 mins):