Neoadjuvant Chemo-endocrine Therapy and Immunotherapy for Pre-menopausal Luminal B Breast Cancer Patients

Summary

Multicentric, phase II neoadjuvant trial in hormone-positive, HER-negative, luminal B, premenopausal breast cancer patients stage II-IIIA. Patients receive as neoadjuvant treatment before surgery: three courses of anthracycline-based chemotherapy followed by exemestane p.o. daily plus nivolumab i.v. 2-weekly for 8 courses. GnRH analogues are started concomitantly with chemotherapy and maintained until the completion of neoadjuvant treatment.

Timeline

Start

2017-10-05

Primary completion

2020-05-25

Completion

2020-05-25

Publications

• Dieci MV, Guarneri V, Tosi A, Bisagni G, Musolino A, Spazzapan S, Moretti G, Vernaci GM, Griguolo G, Giarratano T, Urso L, Schiavi F, Pinato C, Magni G, Lo Mele M, De Salvo GL, Rosato A, Conte P. Neoadjuvant Chemotherapy and Immunotherapy in Luminal B-like Breast Cancer: Results of the Phase II GIADA Trial. Clin Cancer Res. 2022 Jan 15;28(2):308-317. doi: 10.1158/1078-0432.CCR-21-2260. Epub 2021 Oct 19.

Drugs

Indications