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Adding radiation decreases breast cancer recurrence
By Dross at 2007-01-23 22:43


Radiotherapy after breast conserving surgery for breast cancer reduces recurrence and prevents development of additional breast tumors in older women with early stage breast disease, according to a new study. Published in the March 1, 2007 issue of CANCER, a peer-reviewed journal of the American Cancer Society, the study suggests that women also benefit from the recommended five years of tamoxifen treatment for hormone responsive tumors. Among women over 65 and treated with breast conserving surgery, the risk of local or regional recurrence increased up to 3.5 times if they did not receive radiation after their surgery. Great strides have been made in breast cancer treatment. Breast conserving surgery in combination with radiotherapy and mastectomy provide women with two good options for their initial treatment. Augmenting surgery with hormone modulating drugs, such as tamoxifen, further improves survival and reduces recurrence. Women over 65 are at the highest risk for breast cancer and make up half of those diagnosed. However, they are less likely to receive standard therapy, particularly radiotherapy after breast conserving surgery, than younger women. Making treatment recommendations for older patients, who may have more comorbidities than younger patients, is complicated by under-representation of older women in clinical trials and prognostic studies.

read more | 5 comments | 1782 reads

Selective marker found to indicate aggressive form of breast cancer
By Dross at 2007-01-15 23:23

[via Selective marker found to indicate aggressive form of breast cancer]:

PHILADELPHIA -- Researchers have linked a structural protein called nestin to a particularly deadly form of breast cancer, identifying a new biomarker that could lead to earlier detection and better treatment.


In the January 15 issue of Cancer Research, researchers from Dartmouth Medical School demonstrate that nestin could represent a selective biological marker for basal epithelial breast tumors, a highly aggressive cancer with similarities to mammary stem cells, the regenerative cells believed to be the site of breast cancer initiation.

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BN ImmunoTherapeutics Starts Trials with New Breast Cancer Vaccine
By Dross at 2007-01-05 03:37

Clinical trials of a breast cancer vaccine have begun.


BN ImmunoTherapeutics, Inc., a development-stage biotechnology company, today announced that the Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) for the company's investigational breast cancer vaccine, MVA-BN(R)-HER2. A clinical study of MVA-BN(R)-HER2 will begin enrollment at multiple clinical sites in the U.S. in early 2007, and a parallel trial is expected to commence in Europe shortly thereafter. MVA-BN(R)-HER2 will be tested in numerous clinical settings to determine how to best incorporate it into standard therapy for the treatment of metastaticterm breast cancer. This will include treatment with MVA-BN(R)-HER2 in combination with trastuzumab (Herceptin(R)) and chemotherapyterm.

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ADVENTRX Initiates CoFactor Phase II Clinical Trial in Refractory Breast Cancer
By Dross at 2006-12-30 04:34

ADVENTRX Initiates CoFactor Phase II Clinical Trial in Refractory Breast Cancer


SAN DIEGO, Dec. 27 -- ADVENTRX Pharmaceuticals, Inc. (AMEX:ANX) today announced the initiation of a Phase II clinical trial using CoFactor(R) in the treatment of refractory metastaticterm breast cancer. CoFactor (ANX-510) is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-fluorouraciltermtermtermterm (5-FUterm). This study builds on the results of earlier studies and will more fully investigate the efficacy and safety of CoFactor for patients with previously treated, advanced breast cancer. "The initiation of this Phase II clinical trial for CoFactor represents an important milestone in the global registration strategy for our lead product development program," said Evan M. Levine, chief executive officer of ADVENTRX. "We are enthusiastic about CoFactor's potential to enhance the efficacy and safety of 5-FU chemotherapyterm in the treatment of refractory breast cancer."

read more | 1481 reads

Landmark Tykerb(R) (Lapatinib) Data Published in the New England Journal of Medicine
By admin at 2006-12-30 04:03

[via Landmark Tykerb(R) (Lapatinib) Data Published in the New England Journal of Medicine]:

Landmark Tykerbterm(R) (Lapatinib) Data Published in the New England Journal of Medicine Study Authors Also Conclude that Further Investigation Into Earlier Use in the Treatment of HER2 Positive Breast Cancer is Warranted


Data from a Phase III study reporting that Tykerb(R) (lapatinib) plus Xelodaterm(R) (capecitabinetermterm) is superior to capecitabine alone in women with HER2 (ErbB2) positive advanced breast cancer who had progressed following prior therapy, including Herceptin(R) (trastuzumab), was published today in the New England Journal of Medicine (NEJM).(1) Based on the findings, the study authors concluded that given its distinct mechanism of action and activity, as a small molecule dual receptor tyrosine kinase inhibitor, lapatinib should be investigated for use in the earlier treatment of HER2 (ErbB2) positive breast cancer.(1) Lapatinib is an investigational medicinal product and has not been approved for marketing by any regulatory body. "Patients with advanced or metastaticterm HER2 (ErbB2) positive breast cancer have limited options once their cancer has progressed on trastuzumab and standard initial chemotherapyterm regimens. There has been a clear need for alternative treatments to help women with metastatic breast cancer in this advanced setting. Lapatinib combined with capecitabine has demonstrated superior efficacy over capecitabine alone in this group of patients and we look forward to it being made available to women suffering from this devastating disease," said lead investigator Charles Geyer, M.D., Director of Breast Medical Oncology at Allegheny General Hospital, Pittsburgh, Pennsylvania, U.S.A. Study results demonstrate combination treatment with lapatinib was not associated with an increase in either serious toxicity or rates of discontinuation related to adverse events (AEs), compared to capecitabine treatment alone. The most common AEs were diarrhea, hand-foot syndrome and rash distinct from hand-foot syndrome.(1) Metastatic breast cancer is the leading cause of cancer deaths in women globally, resulting in more than 400,000 deaths each year.(2) Women with HER2 positive breast cancer are at a greater risk of disease progression and death compared to those women with tumors that do not over-express HER2.(3) Metastatic breast cancer eventually develops resistance to trastuzumab.(4,5) "We are extremely enthusiastic that NEJM has chosen to publish this important data which we believe will truly change the treatment paradigm for thousands of women suffering from late stage breast cancer," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Centre at GSK. "It is also exciting news that these results suggest there may be a role for Tykerb in the earlier treatment of breast cancer," he added. To access the full manuscript, beginning December 28th, please visit: and click on "Current Issue."

read more | 5 comments | 1254 reads

Compound Boosts Tamoxifen's Cancer-Fighting Power -
By admin at 2006-12-15 04:59

[via Compound Boosts Tamoxifen's Cancer-Fighting Power -]:Adding a second drug to tamoxifen, the breast cancer drug used successfully for more than 20 years, helps it retain its full strength, scientists at the U.S. National Cancer Institute report. Over time, tamoxifen can lose its effectiveness. But the new molecule, called disulfide benzamide or DIBA, could provide a way to overcome that acquired resistance and restore tamoxifen's effectiveness. DIBA "is not a new molecule," noted William Farrar, head of the Cancer Stem Cell Section of the National Cancer Institute's Center for Cancer Research at Frederick, Md., and the study's lead author. "It's been around a while."

read more | 1218 reads

Kosan's Hsp90 Inhibitor, Tanespimycin, Shows Promising Antitumor Activity in Phase 2 Trial of Patients with HER2-Positiv
By admin at 2006-12-15 02:33

HAYWARD, Calif., Dec. 14 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (NASDAQ:KOSN) today presented preliminary data from a Phase 2 clinical trial showing that tanespimycin (KOS-953) in combination with trastuzumab (Herceptin(R)) demonstrated clinically meaningful antitumor activity, including both partial responses and extended stabilization of disease, in patients with trastuzumab-refractory HER2-positive metastatic breast cancer. Preliminary data from the ongoing trial were presented in a poster at the 29th Annual San Antonio Breast Cancer Symposium. The poster was entitled, "Phase 2 trial of Trastuzumab (T) and KOS-953 (17-AAG) in Patients (pts) with HER2-Positive Breast Cancer: Preliminary Results," and was presented by Shanu Modi, M.D., Breast Cancer Medicine Service, Memorial Sloan- Kettering Cancer Center. Clifford A. Hudis, M.D., Chief, Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center, was the senior author on the study. "The demonstration of clinical benefit with tanespimycin combined with trastuzumab, in patients with trastuzumab-refractory HER2-positive metastatic breast cancer, is quite promising," said Dr. Hudis. "The encouraging evidence of tolerability and activity from this Phase 2 trial strongly support the continued development of an Hsp90 inhibitor as a potential treatment for patients with breast cancer whose disease has proven to be resistant to conventional therapy." "We believe that these favorable Phase 2 results with tanespimycin, our first-generation Hsp90 inhibitor, establish an important proof-of-concept for Hsp90 inhibition in the treatment of breast cancer and set the stage for advancing into later-stage trials," said Robert G. Johnson, Jr., M.D., Ph.D., President and Chief Executive Officer of Kosan. "We believe that our second-generation Hsp90 inhibitor, alvespimycin HCl, is optimally suited for further development in breast cancer due to its enhanced pharmaceutical properties including greater potency, longer half-life, ease of formulation and oral bioavailability. A Phase 1/2 trial of alvespimycin in combination with trastuzumab is ongoing and we plan to initiate later-stage trials with alvespimycin in patients with HER2-positive metastatic breast cancer in the first half of 2007. We will continue to develop tanespimycin on a registration path as a treatment for multiple myeloma where the compound has demonstrated promising clinical activity to date." Phase 2 Tanespimycin Results Tanespimycin is an Hsp90 inhibitor that has demonstrated the potential to disrupt the activity of multiple oncogenes and cell signaling pathways implicated in tumor growth, including HER2, a key pathway in breast cancer. The Phase 2 trial of tanespimycin in combination with trastuzumab was designed to determine the objective response rate by RECIST in patients with HER2-positive metastatic breast cancer with tumor progression during treatment with one trastuzumab-containing regimen immediately prior to entering the trial. The dosing schedule for tanespimycin was a two-hour weekly intravenous infusion of 450 mg/m2 administered along with the standard dose of trastuzumab. Of the 12 patients enrolled in the trial, all had one prior trastuzumab containing regimen, and many patients had been heavily pre-treated with additional non-trastuzumab-based cytotoxic chemotherapy. Patients had a median of three prior cytotoxic regimens and four patients had received prior hormonal therapy. Of the eight patients evaluable for efficacy, five (63%) showed signs of clinical benefit (one patient with stable disease was still active in Cycle 3 and was too early to assess for efficacy). * One patient with documented progressive disease in the liver prior to study while being treated with trastuzumab/vinorelbine had a confirmed partial response (53% tumor shrinkage by RECIST) and continues on study (Cycle 9 ); * One patient with documented progressive disease on study for one year post-trastuzumab treatment had an unconfirmed partial response (35% tumor shrinkage by RECIST) and continues on study (Cycle 3 ); and * Three patients who received 4-6 cycles of treatment had stable disease; one with a 20% decrease in measurable disease. The tanespimycin plus trastuzumab regimen was generally well tolerated. Grade 1 and 2 toxicities included fatigue, diarrhea, nausea, vomiting, and Grade 3 toxicity was seen in 3 patients (2 patients with headache, 1 patient with fatigue), all of which were manageable and reversible. Future Development Plans Kosan plans to initiate further trials in HER2-positive metastatic breast cancer using alvespimycin HCl (KOS-1022), a second-generation Hsp90 inhibitor. Alvespimycin has enhanced pharmaceutical properties: longer half-life that allows more flexible dosing; increased potency, enabling potentially lower dosing; good oral bioavailability, and water solubility, enabling ease of formulation. Alvespimycin is currently being tested in several clinical trials: Phase 1b (intravenous formulation) in combination with trastuzumab in HER2 metastatic breast cancer; Phase 1 (oral formulation), as a single agent in solid tumors; and Phase 1 (intravenous formulation) as a single agent in hematological tumors. The compound has demonstrated promising clinical results to date. Kosan anticipates initiating a Phase 2 trial of alvespimycin as a single agent in HER2-positive metastatic breast cancer in the first half of 2007, with subsequent Phase 2/3 trials in HER2-positive metastatic breast cancer in combination with trastuzumab.

read more | 743 reads

Breast cancer patients found to live longer with new drug :: - Houston Chronicle
By admin at 2006-11-22 10:19

Switching patients with early breast cancer from a standard drug to a newer treatment helps them live longer and improves their odds of remaining free of the disease, German researchers said Friday.

Although tamoxifen has been the standard treatment following surgery for women with hormone sensitive tumors, they said changing to a newer class of drug called aromatase inhibitors improved overall survival. "A lot of people have been waiting to see whether aromatase inhibitors will show a survival advantage, and I think these data will assure them that five years of tamoxifen is no longer the standard of care ... ," said Walter Jonat, professor at the University of Kiel in Germany.

read more | 1786 reads

FDA Approves Herceptin(R) for the Adjuvant Treatment of HER2-Positive Node-Positive Breast Cancer
By admin at 2006-11-18 05:44
Only Targeted Biologic Therapy Approved for Use in Adjuvant and Metastatic HER2-positive Breast Cancer -

SOUTH SAN FRANCISCO, Calif., Nov. 16 /PRNewswire-FirstCall/ -- Genentech, Inc. (NYSE-DNA) announced today that the U.S. Food and Drug Administration (FDA) approved Herceptin(R) (Trastuzumab), as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel, for the adjuvant treatment of HER2-positive node-positive breast cancer. Adjuvant therapy is given to women with early-stage (localized) breast cancer who have had initial treatment - surgery with or without radiation therapy - with the goal of reducing the risk of cancer recurrence and/or the occurrence of metastatic disease.
read more | 2928 reads

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