Combination Chemotherapy and Trastuzumab in Treating Women With Stage I, Stage II, or Stage III HER2-Positive Breast Cancer

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known which regimen of combination chemotherapy given together with trastuzumab is most effective in treating breast cancer. PURPOSE: This randomized phase III trial is comparing two different regimens of combination chemotherapy given together with trastuzumab to see how well they work in treating women with HER2-positive stage I, stage II, or stage III breast cancer.

Timeline

Start

2007-12

Primary completion

2010-12

Completion

—

Publications

• Results Guarneri V, Frassoldati A, Bruzzi P, D'Amico R, Belfiglio M, Molino A, Bertetto O, Cascinu S, Cognetti F, Di Leo A, Pronzato P, Crino L, Agostara B, Conte P. Multicentric, randomized phase III trial of two different adjuvant chemotherapy regimens plus three versus twelve months of trastuzumab in patients with HER2- positive breast cancer (Short-HER Trial; NCT00629278). Clin Breast Cancer. 2008 Oct;8(5):453-6. doi: 10.3816/CBC.2008.n.056.
• Conte P, Bisagni G, Piacentini F, Sarti S, Minichillo S, Anselmi E, Aieta M, Gebbia V, Schirone A, Musolino A, Garrone O, Beano A, Rimanti A, Giotta F, Turletti A, Miglietta F, Dieci MV, Vicini R, Balduzzi S, D'Amico R, Guarneri V. Nine-Week Versus One-Year Trastuzumab for Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: 10-Year Update of the ShortHER Phase III Randomized Trial. J Clin Oncol. 2023 Nov 10;41(32):4976-4981. doi: 10.1200/JCO.23.00790. Epub 2023 Sep 25.
• Dieci MV, Bisagni G, Bartolini S, Frassoldati A, Vicini R, Balduzzi S, D'amico R, Conte P, Guarneri V. Type of adjuvant endocrine therapy and disease-free survival in patients with early HR-positive/HER2-positive BC: analysis from the phase III randomized ShortHER trial. NPJ Breast Cancer. 2023 Feb 4;9(1):6. doi: 10.1038/s41523-023-00509-2.
• Dieci MV, Bisagni G, Brandes AA, Frassoldati A, Cavanna L, Giotta F, Aieta M, Gebbia V, Musolino A, Garrone O, Donadio M, Rimanti A, Beano A, Zamagni C, Soto Parra H, Piacentini F, Danese S, Ferro A, Cagossi K, Sarti S, Gambaro AR, Romito S, Bazan V, Amaducci L, Moretti G, Foschini MP, Balduzzi S, Vicini R, D'Amico R, Griguolo G, Guarneri V, Conte PF. Validation of the AJCC prognostic stage for HER2-positive breast cancer in the ShortHER trial. BMC Med. 2019 Nov 21;17(1):207. doi: 10.1186/s12916-019-1445-z.
• Conte P, Frassoldati A, Bisagni G, Brandes AA, Donadio M, Garrone O, Piacentini F, Cavanna L, Giotta F, Aieta M, Gebbia V, Molino A, Musolino A, Ferro A, Maltoni R, Danese S, Zamagni C, Rimanti A, Cagossi K, Russo A, Pronzato P, Giovanardi F, Moretti G, Lombardo L, Schirone A, Beano A, Amaducci L, Bajardi EA, Vicini R, Balduzzi S, D'Amico R, Guarneri V. Nine weeks versus 1 year adjuvant trastuzumab in combination with chemotherapy: final results of the phase III randomized Short-HER studydouble dagger. Ann Oncol. 2018 Dec 1;29(12):2328-2333. doi: 10.1093/annonc/mdy414.

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Indications