New Taxotere(R) (docetaxel) Injection Concentrate Data To Be Presented At The 30th Annual San Antonio Breast Cancer Symposium (SABCS)

Main Category: Breast Cancer
Also Included In: Conferences;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 08 Dec 2007 - 0:00 PDT

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Among the 62 oral abstracts accepted for presentation at the 30th annual San Antonio Breast Cancer Symposium (SABCS), six with Taxotere(R) (docetaxel) Injection Concentrate investigational regimens will be presented in plenary sessions.

-- Plenary Lecture 1 on the opening day of the symposium will review data for systemic adjuvant therapies being investigated for the treatment of breast cancer.

"The worldwide overview: New results for systemic adjuvant therapies." Peto R, Early Breast Cancer Trialists' Collaborative Group (EBCTCG), University of Oxford, UK.

Thursday, December 13, 2007, 8:55 AM / Plenary lecture 1, Exhibit Hall D

-- The data from studies with Taxotere(R)-based regimens and anthracycline-based regimens will be discussed through two presentations:

Abst 12: "Extended follow-up and analysis by age of the US Oncology Adjuvant trial 9735." Jones S, et al; US Oncology Research, Inc., Houston, TX.

Thursday, December 13, 2007, 9:45AM / Plenary lecture 1, Exhibit Hall D

This presentation includes the updated analysis (seven years median follow-up) of a randomized trial comparing four cycles of a standard anthracycline regimen, doxorubicin/cyclophosphamide (AC), to a non anthracycline regimen, Taxotere(R)/cyclophosphamide (TC). New findings regarding overall survival as well as the effect of age on efficacy and safety will be presented.

Abst 13: "Role of anthracycline-based therapy in the adjuvant treatment of breast cancer: efficacy analyses determined by molecular subtypes of the disease." Slamon DJ, et al; Cancer International Research Group (CIRG), Edmonton, AB, Canada.

Thursday, December 13, 2007, 10:00 AM / Plenary lecture 1, Exhibit Hall D

Based on survival data previously reported for the BCIRG 006 study, this presentation will describe how molecular subtypes of early stage breast cancer could be used to identify appropriate Taxotere(R)-based therapies, either with or without anthracyclines, for women with HER2 positive tumors.

-- Two other oral presentations will discuss studies involving anthracycline regimens with or without Taxotere(R):

Abst 78: "Preliminary results of the UK Taxotere(R) as Adjuvant Chemotherapy (TACT) Trial." Ellis PA, et al; United Kingdom. Sunday, December 16, 2007, 10:45 AM / General session 7, Exhibit Hall D The UK TACT Trial, a large multicenter phase III randomized trial compared four cycles of sequential FEC* followed by four cycles of Taxotere(R) 100mg/m2 every three weeks to standard UK operable breast cancer adjuvant chemotherapy (FEC* or E-CMF*) for eight cycles.

FEC : Fluorouracil 600mg/m squared, Epirubicin 60 mg/m2 , and Cyclophosphamide 600 mg/m2 q 3wk x 8

E-CMF: Epirubicin 100 mg/m2 q3wk x 4 followed by Cyclophosphamide100 mg/m2 PO d1-14 or 600 mg/m2 IV d1-8, Methotrexate 40 mg/m2, and Fluorouracil 600 mg/m2 q 4wk x 4

Abst 72: "Three-year follow-up of trastuzumab following adjuvant chemotherapy in node positive HER2-positive breast cancer patients: results of the PACS-04 trial." Spielmann M, et al.

Sunday, December 16, 2007, 9:15 AM / General session 7, Exhibit Hall D

Following the PACS-01 trial, the PACS-04 randomized, multicenter, phase III trial is designed to evaluate concomitant Taxotere(R) and epirubicin versus a standard French chemotherapy regimen (FEC 100) in the adjuvant treatment of node-positive early breast cancer, and the sequential use or not of trastuzumab for HER2 positive patients.

FEC100: Fluorouracil 500 mg/m2, Epirubicin 100 mg/m2, Cyclophosphamide 500 mg/m2 q 3 wk x 6

-- Taxotere(R) data in the neoadjuvant setting will also be presented:

Abst 79: "Evaluating the efficacy of capecitabine given concomitantly or in sequence to epirubicin/cyclophosphamide docetaxel as neoadjuvant treatment for primary breast cancer. First efficacy analysis of the GBG/AGO intergroup-study "GeparQuattro". von Minckwitz G, et al.

Sunday, December 16, 2007, 11:00 AM / General session 7, Exhibit Hall D

Prior to surgery, patients were treated with epirubicin and cyclophosphamide followed by either Taxotere(R) alone (100 mg/m squared), Taxotere(R) (75 mg/m squared) combined with capecitabine (1800 mg/m squared), or Taxotere(R) (100mg/m2) followed by capecitabine (1800mg/m2). The primary endpoint of the study is the pathologic complete response at surgery.

-- Data from another investigational non-anthracycline Taxotere(R)-based regimen will be presented from a study in patients with advanced HER2 positive breast cancer:

Abst 309: "Evaluation of trastuzumab, docetaxel and capecitabine as first- line therapy for HER2-positive locally advanced or metastatic breast cancer." Wardley A, et al.

Friday, December 14th, 2007 5:00-7:00 PM / Poster discussion session 3, Antibodies and Immunotherapy - Ballroom B

About Breast Cancer

Breast cancer is the most frequently diagnosed cancer in women. It is the second-leading cause of cancer death in women after lung cancer, and since 1990 is increasing predominantly in women 50 and over. It is the first cause of cancer mortality in women of 40 to 59 years old. According to the American Cancer Society, an estimated 200,000 women are diagnosed with breast cancer and approximately 40,000 women die of the disease in the United States every year. A woman is diagnosed with breast cancer in the United States every three minutes. The risk of a woman developing breast cancer during her lifetime is approximately 13 percent (about one in seven of all women in the United States). In the European Union, more than 191,000 new cases are diagnosed each year and more than 60,000 women will die. Of women with breast cancer, 20 to 25% of these women will have HER2 positive breast cancers. With earlier screening and diagnosis, early management of patients may offer better chances of survival.

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