Avastin Clinical trial

Hi Erika,

under Help me get through treatment, topic clinical trial e5103....thats about an Avastin trial.  It is a blind trial, I am in it and was receiving the drug through my 4 DD A/C treatments and 12 weekly taxol treatments and now that I'm done with those I go on for 10 more treatments, every 3 weeks of just Avastin.  Many doctors have great hope that Avastin is really going to help us, so find comfort in that I know I do. 

When do you start treatment and what kind of treatment are you going to be doing?

Teresa

I am on Avastin and Taxol with Zometa added in.  I am not in a trial, so I can't help with that aspect, but I too have great hope for the Avastin.  Below is a press release from the company that makes Avasting from a few days ago,.  The results look great.  Their stock went up 3 bucks a share today

Deb C 

Saturday, May 31, 2008

Second Phase III Study of Avastin Plus Chemotherapy Shows Improved Progression-
Free Survival in Women With Advanced HER2-Negative Breast Cancer

-- Positive AVADO Results Support Efficacy and Safety of Avastin in First-
Line Metastatic Breast Cancer --

Chicago -- May 31, 2008 -- Genentech, Inc. (NYSE: DNA) today announced
that Avastin® (bevacizumab), in combination with docetaxel chemotherapy,
significantly increased the time women with metastatic breast cancer
receiving first-line therapy lived without their disease advancing, as
defined by the primary endpoint of progression-free survival (PFS). In
this Roche-sponsored, placebo-controlled Phase III trial (AVADO), two
dose levels of Avastin in combination with docetaxel chemotherapy showed
a statistically significant improvement in PFS compared to docetaxel
chemotherapy alone, according to an investigator-assessed analysis. No
new safety signals for Avastin were observed in the study. The results
were featured today during a press briefing at the 44th Annual Meeting
of the American Society of Clinical Oncology (ASCO) and will be
presented tomorrow by David Miles, M.D., medical oncologist, Mount
Vernon Hospital, United Kingdom (Abstract # LBA1011 - June 1, 2008 at
8:30 a.m. CDT in E Hall D1).

"These results build upon previous data and expand our understanding of
Avastin's efficacy and safety when combined with another commonly used
taxane chemotherapy," said Dr. David Miles, principal investigator of
the study. "Importantly, this study supports that Avastin can be used
with taxane-based chemotherapy to provide a meaningful benefit for
patients with advanced HER2-negative breast cancer."

Genentech is required to submit to the U.S. Food and Drug Administration
(FDA) by mid-2009 the results of AVADO and RIBBON I, a third Phase III
study in first-line metastatic breast cancer. Results for the RIBBON I
study are expected later this year.

The pre-specified analysis of AVADO for U.S. regulatory purposes showed
that Avastin combined with chemotherapy improved PFS by up to 64 percent
(hazard ratio of 0.61; p<0.0001) in the 15 mg/kg treatment arm and by up
to 45 percent (hazard ratio of 0.69; p=0.0035) in the 7.5 mg/kg
treatment arm, compared to chemotherapy alone. Overall response rate, a
secondary endpoint, was also positive and supported the PFS benefit
observed in this study. After one year, 83 percent and 78 percent of
patients were alive in the 15 mg/kg and 7.5 mg/kg Avastin treatment
arms, compared to 73 percent of patients receiving chemotherapy alone.

"The totality of the AVADO results, including positive primary and
secondary endpoints and reassurances of safety, support the benefit of
Avastin in extending the time women lived without their disease
progressing when combined with chemotherapy as a first-line treatment,"
said Susan Desmond-Hellmann, M.D., M.P.H., president, Product
Development. "We are committed to fully evaluating Avastin's efficacy
and safety in metastatic breast cancer and anticipate the results of a
third Phase III trial later this year."

About AVADO AVADO was an international, multicenter, randomized, double-
blind, placebo-controlled clinical trial that enrolled 736 patients with
locally recurrent or metastatic HER2-negative breast cancer who had not
received chemotherapy for their metastatic disease. Patients were
randomized to one of two doses of Avastin (15 mg/kg or 7.5 mg/kg) or
placebo given every three weeks in combination with docetaxel
chemotherapy for a maximum of nine cycles. Patients discontinuing
docetaxel for toxicity or after nine cycles were to continue on Avastin
only or placebo until disease progression. The AVADO study was not
designed to compare the two dose levels of Avastin.

In the 15 mg/kg and 7.5 mg/kg Avastin treatment arms, the 64 percent and
45 percent improvements in PFS observed can also be referred to as 39
percent and 31 percent reductions in the risk of cancer progression or
death. Median PFS was 8.8 months, 8.7 months and 8.0 months in the 15
mg/kg and 7.5 mg/kg Avastin plus chemotherapy arms and the chemotherapy
alone arm, respectively. Overall response rates were 63 percent
(p=0.0001) and 55 percent (p=0.0295) in the 15 mg/kg and 7.5 mg/kg
Avastin plus chemotherapy arms, compared to 44 percent in the
chemotherapy alone arm.

The study protocol specified analyses for overall survival at the time
of primary endpoint analysis and 24 months after the last patient was
enrolled. The final analysis for overall survival is expected in 2009.
Hazard ratios for the preliminary analysis of overall survival are 0.68
and 0.92 for the 15 mg/kg and 7.5 mg/kg Avastin arms, respectively.
These initial results for overall survival are not statistically
significant and are based on early information.

Efficacy Results 15 mg/kg Avastin + docetaxel1 7.5 mg/kg Avastin +
docetaxel1 Placebo + docetaxel1 Progression-Free Survival (PFS)2

     Overall PFS Improvement Risk Reduction Hazard Ratio p-value

64% 39% .61 p<0.0001

45% 31% .69 p=0.0035

N/A Median PFS (months) 8.8 8.7 8.0 Overall Response Rate (%)3

p-value 63

p=0.0001 55

p=0.0295 44

1-Year Survival Rate (%) 83 78 73 Overall Survival (not mature)

Hazard Ratio

.68

.92

O/A

1 Each Avastin + docetaxel arm was studied against placebo + docetaxel.
The study was not designed to compare the two Avastin arms. 2 Pre-
specified primary endpoint analysis for U.S. regulatory purposes. 3
Among patients with measurable disease at baseline.

The AVADO study provided a comprehensive safety assessment of the
Avastin and docetaxel combination by using a placebo control arm and
collecting Grade 1 to 5 adverse events in all arms of the study. The
most common severe adverse events were generally consistent with
those observed in a previous Phase III study of Avastin in metastatic
breast cancer.

Safety Results
% (n) 15 mg/kg Avastin
+ docetaxel 7.5 mg/kg Avastin
+ docetaxel Placebo
+ docetaxel Grade 3-5 Adverse Events (AEs) 74% (183/247) 75% (187/250)
  67% (156/233) &#8805;Grade 3 Hypertension 3.2% (8/247) 0.4% (1/250)
  1.3% (3/233) &#8805;Grade 3 Febrile neutropenia 16.6% (41/247) 15.2%
  (38/250) 12.0% (28/233) &#8805;Grade 3 Skin exfoliation 1.2% (3/247)
  2.4% (6/250) 0% (0/233) &#8805;Grade 3 Mucosal inflammation 4.9%
  (12/247) 4.0% (10/250) 0.4% (1/233) Grade 5 AEs (deaths during blinded
  study treatment not due to breast cancer) 1.6% (4/247) 1.6% (4/250)
  2.6% (6/233)

About Breast Cancer Breast cancer is the second most common form of
cancer and second leading cause of cancer deaths among American
women. According to the American Cancer Society, an estimated 182,000
women will be diagnosed with breast cancer and approximately 40,000
will die from the disease in the U.S. in 2008. Genentech estimates
that 75 percent of women with newly diagnosed metastatic breast
cancer are HER2-negative.

About Avastin Avastin is a therapeutic antibody designed to specifically
inhibit vascular endothelial growth factor (VEGF), a protein that plays
an important role in angiogenesis and the maintenance of existing blood
vessels throughout the lifecycle of a tumor. By inhibiting VEGF, Avastin
is designed to interfere with the blood supply to a tumor, which is
thought to be critical to a tumor's ability to grow and spread in the
body (metastasize).

Avastin is indicated for the first- and second-line treatment of
metastatic colorectal cancer in combination with intravenous 5-FU-based
chemotherapy, and for the first-line treatment of unresectable, locally
advanced, recurrent or metastatic non-squamous, non-small cell lung
cancer (NSCLC) in combination with carboplatin and paclitaxel. For more
information on angiogenesis, visit http://www.gene.com/. For full
Prescribing Information and Boxed Warnings on Avastin, visit
http://www.avastin.com/.

Avastin Safety Avastin has a well-characterized safety profile in its
approved indications. The most serious adverse events associated with
Avastin across all trials were gastrointestinal perforation, wound
healing complications, hemorrhage, non-GI fistula formation, arterial
thromboembolic events, hypertensive crisis, reversible posterior
leukoencephalopathy syndrome (RPLS), neutropenia and infection,
nephrotic syndrome and congestive heart failure.

The most common severe adverse reactions (NCI-CTC Grade 3-5) across
clinical trials in metastatic colorectal cancer, NSCLC, and metastatic
breast cancer that occurred at a higher incidence (greater than or equal
to 2 percent higher rate vs. controls) were hypertension, proteinuria
and headache.

About Genentech Founded more than 30 years ago, Genentech is a leading
biotechnology company that discovers, develops, manufactures and
commercializes medicines for patients with significant unmet medical
needs. The company has headquarters in South San Francisco, California
and is listed on the New York Stock Exchange under the symbol DNA. For
additional information about the company, please visit
http://www.gene.com/.

###
This press release contains forward-looking statements regarding the
safety and efficacy of Avastin, the benefit of Avastin for patients, and
the timing of data availability. Such statements are predictions and
involve risks and uncertainties such that actual results may differ
materially. Actual results may be affected by a number of factors
including, but not limited to, unexpected safety, efficacy or
manufacturing issues, difficulty enrolling patients in clinical trials,
the need for additional data, data analysis or clinical studies, BLA
preparation, FDA actions or delays, failure to maintain FDA approval,
competition, pricing, reimbursement, the ability to supply product,
product withdrawals and new product approvals and launches, and
intellectual property or contract rights. Please also refer to the risk
factors described in Genentech's periodic reports filed with the
Securities and Exchange Commission. Genentech disclaims, and does not
undertake, any obligation to update or revise any forward-looking
statement in this press release.

 © Genentech, Inc.

Deb,

Thanks for posting that...of course I couldn't make heads or tails of it.  I have no idea what it says about my clinical trial.  I am doing a phase III trial.  I don't have mets.  I had positive nodes which was why I qualified or you had to be high risk for reoccurrance and trip neg qualified. 

Teresa

Deb,

I know if I dug back far enough I could probably find the answer to this, but what was your first chemo?  I'm wondering how well the Avastin does without the Taxol/taxotere, since my first chemo was TAC x 6/every three weeks.  I don't know if I'd get taxotere again.

Right now I'm on Cisplatin/Gemzar.  Was supposed to be 2 wks on 1 wk off x 4 but my blood counts have messed that up so now hoping to go to every other week.  I was almost half way through...  The onc says after that I'll hav a month off and then go to Xeloda?

Anyway, sorry to hijack the thread, but I was just wondering about your first tx history.

Thanks

Eyes