- Roche in Collaboration With Genentech Commit to Large Phase III
Adjuvant Clinical Programme Set to Unlock Avastin's Potential in
Early Breast Cancer
SAN ANTONIO, TX, Dec. 17 /CNW/ - According to new phase II study data,
Avastin (bevacizumab) can proceed to be tested after breast cancer surgery in
combination with anthracycline containing regimens. These findings pave the
way for Avastin's use as a curative treatment for women with this devastating
disease. Data presented today at the San Antonio Breast Cancer Symposium
(SABCS) from the E2104 study showed that standard anthracycline-based
chemotherapy (doxorubicin) can be added to Avastin after surgical removal of
the breast tumour, without a concerning increase in the incidence of cardiac
adverse events typically associated with this form of chemotherapy.
These data support the commencement of phase III adjuvant breast cancer
clinical programme which will include over 10,000 patients with early stage
breast cancer. Avastin already offers women with late-stage (metastatic)
breast cancer the chance to live twice as long without their disease
"The unique way Avastin works also lends itself for use in women with
earlier stages of breast cancer," said Dr Kathy Miller of Indiana University
School of Medicine, USA and principal investigator of the E2104 study. "We now
know that Avastin use in combination with anthracyclines does not result in
concerning rates of cardiac dysfunction in the adjuvant setting and armed with
this evidence Avastin's impact can be fully validated in a large worldwide
phase III clinical trial programme."
Data from the E2104 study have shown that cardiac dysfunction is not a
major concern with the treatment combination of Avastin and doxorubicin. As
presented in SABCS, two patients with symptomatic congestive heart failure
were reported in each of the 2 Avastin-containing treatment arms which
included more than 100 patients each. This is within the range expected to
occur with the use of anthracycline based chemotherapy alone.
Following the completion of the accrual of Avastin adjuvant colon cancer
trials and now confirmation of the safety of Avastin in the adjuvant breast
cancer setting, the phase III adjuvant breast cancer programme is already
recruiting patients. The large adjuvant programme consists of 2 trials in
HER-2 negative breast cancer patients:
- The E5103 study is set to include 4,950 patients and will compare
Avastin with the addition of an anthracycline-containing chemotherapy
course versus anthracycline-containing chemotherapy alone.
- The BEATRICE study will investigate Avastin in combination with
standard chemotherapies compared to chemotherapies alone in
2,530 planned patients who are not candidates for hormonal therapy.
In addition, Avastin is being investigated in HER-2 positive breast
cancer patients post surgery via the BETH trial. This study will investigate
the addition of Avastin to Herceptin (trastuzumab) in combination with
established chemotherapy regimen.
Worldwide, breast cancer is the leading cause of cancer death in women
under the age of 55. Each year there are more than one million diagnoses and
more than 400,000 deaths from breast cancer(2).
E2104 is a phase II study designed to evaluate the safety and feasibility
of incorporating Avastin into an anthracycline containing adjuvant therapy
regimen. The study included 226 women with lymph node positive breast cancer
who have had already undergone surgical removal (mastectomy) of the lesion and
lymph node dissection. The study was sponsored by the National Cancer
Institute (NCI), part of the US National Institutes of Health, and conducted
by a network of researchers led by the Eastern Cooperative Oncology Group
(ECOG). Patients were sequentially assigned to one of two treatment arms:
- Treatment arm A received dose-dense combination of doxorubicin and
cyclophosphamide with Avastin, followed by paclitaxel and Avastin,
followed by Avastin alone. Avastin was given every 2 weeks at a dose
of 10 mg/kg for 1 year.
- Treatment arm B was only different to arm A in that Avastin was
introduced after completion of doxorubicin therapy in conjunction
with paclitaxel. As with arm A, patients remained on Avastin for
1 year after Avastin initiation.
The primary objective of the study was to determine the incidence of
clinically apparent cardiac dysfunction in patients with lymph node positive
breast cancer treated with bevacizumab and dose dense
doxorubicin/cyclophosphamide followed by paclitaxel (ddAC(greater than)T).
Patients were evaluated clinically and with serial assessments of left
ventricular function over the course of their treatment and for six months
- Roche in Oncology:
- Roche Health Kiosk, Cancer: http://www.health-kiosk.ch/start_krebs
(1) Miller KD, et al. E2100 Breast Cancer Res Treat 2005;94:S6
(2) Kamangar F, et al. J Clin Oncol 2006; 24(14): 2137-50.
For further information:
For further information: Roche, Christine Mage-Hill, +41(0)61688995;
Galliard Healthcare, Dominic Elliston, +44(0)2076632266