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High-dose chemotherapy with peripheral blood progenitor cell support in breast cancer: WSG AM01 and MM01

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Breast Cancer Research20013 (Suppl 1) :A44

https://doi.org/10.1186/bcr371

  • Received: 10 May 2001
  • Published:

Keywords

  • Breast Cancer
  • Tamoxifen
  • Metastatic Breast Cancer
  • Trial Test
  • Interim Analysis
The WSG as a German interdisciplinary group initiated 05/94 a large multicentre phase III trial to evaluate adjuvant high-dose chemotherapy in high-risk breast cancer. About 100 centres all over Germany participated. The second trial in metastatic breast cancer (MBC) was initiated in 4/97 in co-operation with the German Intergroup. The main characteristics of the two trials are listed in Table 1.

Table 1

 

AM 01

MM01

Patients

Adjuvant N>9

M1, PR or CR after conventional

  

   induction, ER

Arm A

Tandem-E,C,TT

STAMP V

Arm B

EC ×4 → CMF ×3

Tandem STAMP V

 

   q2w + G-CSF

 

Actually randomized

368

180/480

Status

Open

Open

Treatment related

0%

1.5%

   mortality (%)

  

The first trial tests high-dose Tandem E90C3000T400 + PBPC versus dose-dense conventional chemotherapy with G-CSF support. All patients received irradiation of the chest wall and the supraclavicular lymph nodes, and tamoxifen in case of ER+ tumors. The trial will probably be closed by the end of the year. The first interim analysis was done in 1/99, and the second one is planned in 1/02. Interim data will be presented. The trial in MBC randomizes chemosensitive, ER-negative patients to 1× versus 2× STAMPV. The first interim analysis was done in 12/00. Data will be presented.

Copyright

© BioMed Central Ltd 2001

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