Country

Germany

Chair

for AM03:, U. Nitz, Department of Gynaecology, University of Düsseldorf Moorenstraβe 5, 40221 DÜSSELDORF, GERMANY. Tel: +492118117550 Fax: +49211312283 Email: [email protected]

For AM02:, U. Nitz and W. Kuhn (AGO – Mamma), Department of Gynaecology, University of Bonn, Sigmund-Freud St. 25, 53105 BONN, GERMANY.

Biostatistics Unit

for AM02:, M. Scholz, Trium Analysis Online GmbH, C/o IMSE, TU München, Kilinikum rd. Isar, Ismaninger St. 22, 81675 MÜNCHEN, GERMANY.

For AM03:, K. Ulm, Klinikum rd. Isar, Institut für Medizinische Statistik und Epidemiologie, Ismaninger St. 22, 81675 MÜNCHEN, GERMANY.

Study Center

Department of Gynaecology, University of Düsseldorf, Moorenstraβe 5, 40221 DÜSSELDORF, GERMANY. Email: [email protected]

Website

www.wsg-online.com

Title

WSG and AGO-Mamma Intergroup Study: Randomized phase III trial of EC→Doc: adjuvant chemotherapy of breast carcinoma with 1–3 positive lymph nodes. EC-DOC (AM02)

Coordinator(s)

U. Nitz (WSG), Department of Gynecology, Breast Centre, University of Düsseldorf DÜSSELDORF, GERMANY. Tel: +49 21 1811 7550 Fax: +49 21 1312 283 Email: [email protected] Website: www.wsg-online.com

W. Kuhn (AGO-Mamma), Department of Gynecology, University of Bonn, Sigmund-Freud St. 25, 53105 BONN, GERMANY.

Biostatistics Unit

M. Scholz, Trium Analysis Online GmbH, C/o IMSE, TU München, Kilinikum rd. Isar, Ismaninger St. 22, 81675 MÜNCHEN, GERMANY.

Summary

• Opened in September 2000, closed in August 2005
• Target accrual: 2000

Objectives

• Event free survival (EFS) and overall survival (OS)
• Comparison of:

(a) Toxicity

(b) Quality of Life (QOL)

(c) Cost effectiveness analysis

Scheme

Update

• Randomisation closed; 2011 patients randomised.

Related Publications

Huober J, Thomssen C, Fischer H, et al. First toxicity analysis of a randomized adjuvant German Intergroup Phase 3-Study for patients with primary breast cancer (bc) with 1–3 involved lymph nodes comparing six cycles FEC or CMF to four cycles of EC followed by 4 cycles of Docetaxel (Doc). EBCC, Hamburg 2004

Samuelkutty S, Gluz O, Mohrmann S, et al. Chemotherapy-induced amenorrhea (CIA) in patients treated with adjuvant CEF/CMF or EC/docetaxel: analysis from a phase III randomized EC/Doc Trial. SABCS 2005: Breast Cancer Res Treat 2005; 94(Suppl 1) ^*2063

Schütt G, Mohrmann S, Kuhn W, et al. Age-associated incindence of chemotherapy-related amenorrhea (CRA) and results of the second toxicity analysis of a WSG/AGO-Mamma Intergroup Phase III trial AM02 “EC → Doc” for patients with primary breast cancer and 1–3 positive axillary lymph nodes. St Gallen Consensus Conference 2005.

Topics

• Taxanes
• Node positive breast cancer

Keywords

Breast cancer, chemotherapy, 1–3 involved lymph nodes, taxanes

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Title

WSG Study: Randomized phase III trial of adjuvant CEF/TAC chemotherapy +/− Darbepoetin alfa for patients with primary breast cancer and more than 3 positive axillary lymph nodes. ARA Plus (AM03)

Coordinator(s)

U. Nitz (WSG), Department of Gynecology, University of Düsseldorf, DÜSSELDORF, GERMANY. Tel: +49 21 1811 7550 Fax: +49 21 1312 283 Email: [email protected] Website: www.brustcentrum.de

Biostatistics Unit

13 / SKM Oncology, Prof. Dr. I. Zuna, 65183 WIESBADEN, GERMANY.

Summary

• Target accrual: 1234

Objectives

• Event-free survival (EFS).
• Overall Survival (OS).
• Comparison of toxicity, anaemia and cognitive function.
• Comparison of fatigue syndrome.

Scheme

Update

• 650 patients randomized at end September 2006.

Related Publications

None available

Topics

• Node positive breast cancer

Keywords

Erythropoetin

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Title

ICE – Study: Ibandronate with or without capecitabine in elderly patients with early breast cancer. BIG 4-04 / GBG 32. (see also description under GBG)

Coordinator(s)

An Intergroup Study of the: Westdeutsche Studiengruppe (WSG), Arbeitsgemeinschaft Gynäkologische Onkologie (AGO), German Breast Group (GBG), Nordostdeutsche Gesellschaft für Gynäkologische Onkologie (NOGGO).

Protocol Board

Professor Dr U. Nitz, Düsseldorf (Principal investigator; WSG), PD Dr D. Elling, Berlin (NOGGO), Professor Dr V. Möbus Frankfurt (AGO), PD Dr G. von Minckwitz Frankfurt (GBG).

Summary

Primary Objective

• To compare the event-free survival in elderly patients after local treatment for primary breast cancer treated with either ibandronate alone or ibandronate and capecitabine as adjuvant treatment.

Secondary Objectives

• To compare the overall survival between the two Arms.
• To determine the compliance in both Arms.
• To determine the toxicity in both Arms.
• To determine the rate of bone-related events in hormonsensitive and insensitive disease (with or without anastrozol).
• To determine the preference to oral or intravenous application of ibandronate.
• To assess quality of life.

Tertiary Objective

• To determine prognostic factors on tumor tissue collected from primary surgery and to correlate them with study treatment effect.

Scheme

Update

• Planned accrual: 1394 patients.

Related Publications

None available

Topics

• Bisphosphonates
• Capecitabine
• Elderly patients
• Hormonal therapy
• Predictive markers

Keywords

None available