Anthracycline-free Taxane Based Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer

Summary

The planned trial compares an anthracycline-free taxane based regimen versus a modern third generation (anthracycline/taxane-based) regimen in HER2/neu non-over expressing tumors. The aim is to define a further anthracycline-free standard and to spare anthracycline toxicity to a patient, who will only have a modest benefit from this compound. Prior to randomization for chemotherapy for all patients with HR positive disease OncotypeDX® will be performed to identify patients who should not receive chemotherapy. Secondary objectives of this trial will be to compare overall survival and toxicity between the two chemotherapy arms, to evaluate survival in the observation arm and to perform translational research regarding prognostic and predictive factors.

Timeline

Start

2009-02-05

Primary completion

2017-03-01

Completion

2018-05-15

Publications

• Sechi A, Mijnes J, Villwock S, Rose M, Steib F, Bringezu S, Berger J, Schalla C, von Serenyi S, Dietrich J, Ortiz-Bruchle N, Heij L, Bednarsch J, Gluz O, Nitz U, Harbeck N, Graeser M, Zu Eulenburg C, Mohammadian MP, Jozwiak K, Kreipe HH, Christgen M, Radner M, Jonigk D, Dahl E. The Janus Face of SPAG6: Inducing EMT in Luminal Breast Cancer Cells Amidst Widespread Expression Loss in Breast Tumours. J Cell Mol Med. 2025 Oct;29(19):e70870. doi: 10.1111/jcmm.70870.
• Kolberg-Liedtke C, Gluz O, Heinisch F, Feuerhake F, Kreipe H, Clemens M, Nuding B, Malter W, Reimer T, Wuerstlein R, Graeser M, Shak S, Nitz U, Kates R, Christgen M, Harbeck N. Association of TILs with clinical parameters, Recurrence Score(R) results, and prognosis in patients with early HER2-negative breast cancer (BC)-a translational analysis of the prospective WSG PlanB trial. Breast Cancer Res. 2020 May 14;22(1):47. doi: 10.1186/s13058-020-01283-w.
• Nitz U, Gluz O, Clemens M, Malter W, Reimer T, Nuding B, Aktas B, Stefek A, Pollmanns A, Lorenz-Salehi F, Uleer C, Krabisch P, Kuemmel S, Liedtke C, Shak S, Wuerstlein R, Christgen M, Kates RE, Kreipe HH, Harbeck N; West German Study Group PlanB Investigators. West German Study PlanB Trial: Adjuvant Four Cycles of Epirubicin and Cyclophosphamide Plus Docetaxel Versus Six Cycles of Docetaxel and Cyclophosphamide in HER2-Negative Early Breast Cancer. J Clin Oncol. 2019 Apr 1;37(10):799-808. doi: 10.1200/JCO.18.00028. Epub 2019 Feb 20.
• Nitz U, Gluz O, Christgen M, Kates RE, Clemens M, Malter W, Nuding B, Aktas B, Kuemmel S, Reimer T, Stefek A, Lorenz-Salehi F, Krabisch P, Just M, Augustin D, Liedtke C, Chao C, Shak S, Wuerstlein R, Kreipe HH, Harbeck N. Reducing chemotherapy use in clinically high-risk, genomically low-risk pN0 and pN1 early breast cancer patients: five-year data from the prospective, randomised phase 3 West German Study Group (WSG) PlanB trial. Breast Cancer Res Treat. 2017 Oct;165(3):573-583. doi: 10.1007/s10549-017-4358-6. Epub 2017 Jun 29.
• Gluz O, Nitz UA, Christgen M, Kates RE, Shak S, Clemens M, Kraemer S, Aktas B, Kuemmel S, Reimer T, Kusche M, Heyl V, Lorenz-Salehi F, Just M, Hofmann D, Degenhardt T, Liedtke C, Svedman C, Wuerstlein R, Kreipe HH, Harbeck N. West German Study Group Phase III PlanB Trial: First Prospective Outcome Data for the 21-Gene Recurrence Score Assay and Concordance of Prognostic Markers by Central and Local Pathology Assessment. J Clin Oncol. 2016 Jul 10;34(20):2341-9. doi: 10.1200/JCO.2015.63.5383. Epub 2016 Feb 29.

Drugs

Indications