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Mini Oral - Breast cancer, early stage

162MO - Neoadjuvant chemotherapy and immunotherapy in Luminal B BC: Results of the phase II GIADA trial


18 Sep 2020


Mini Oral - Breast cancer, early stage


Cytotoxic Therapy;  Immunotherapy

Tumour Site

Breast Cancer


Maria Vittoria Dieci


Annals of Oncology (2020) 31 (suppl_4): S303-S339. 10.1016/annonc/annonc267


M.V. Dieci1, V. Guarneri2, G. Bisagni3, A. Tosi1, A. Musolino4, S. Spazzapan5, G. Moretti3, G.M. Vernaci6, T. Giarratano6, M. Lo Mele7, A. Rosato1, G.L. De Salvo8, P.F. Conte1

Author affiliations

  • 1 Department Of Surgery, Oncology And Gastroenterology, University of Padova, 35128 - Padova/IT
  • 2 Department Of Surgery, Oncology And Gastroenterology Instituto Oncologico Veneto Irccs, University of Padova, 35128 - Padova/IT
  • 3 Department Of Oncology And Advanced Technologies, Oncology Unit, Azienda USL-IRCCS, 42100 - Reggio Emilia/IT
  • 4 Medical Oncology Unit,, University Hospital of Parma, Parma/IT
  • 5 Oncology, CRO National Cancer Institute, Aviano/IT
  • 6 Medical Oncology 2, Istituto Oncologico Veneto IOV-IRCCS, 35128 - Padova/IT
  • 7 Pathology, Azienda Ospedale Università Padova, Padova/IT
  • 8 Clinical Research Unit, Istituto Oncologico Veneto IOV-IRCCS, 35128 - Padova/IT


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Abstract 162MO


The role of immunotherapy in HR+/HER2- breast cancer is underexplored. The GIADA trial (EUDRACT 2016-004665-10) is a phase II study of neoadjuvant chemotherapy, nivolumab and endocrine therapy for Luminal B breast cancer patients.


Premenopausal patients with Luminal B breast cancer (HR+/HER2- and G3 or Ki67>20%) candidate to neoadjuvant chemotherapy received: 3 cycles of epirubicin/cyclophosphamide Q3W followed by 8 cycles of nivolumab 240 mg Q2W, triptorelin started concomitantly to chemotherapy and exemestane started concomitantly to nivolumab. To reject the null hypothesis, at least 8/43 pCR (ypT0/is and ypN0) had to be observed. Secondary endpoints included safety and biomarkers.


43 patients were included: median age 45y, clinical stage II (81%) and IIIA (19%). All patients started treatment and underwent surgery, 42 received >1 nivolumab dose. A pCR was achieved by 7 patients (16.3%; 95%CI 7.4-34.9). Most common Grade >3 treatment-related AEs during nivolumab were: GGT (18.6%), ALT (16.3%) and AST (9.3%) increase. Most common immune-related AEs were: hyperthyroidism (18.6%), hypothyroidism (14.0%), skin AEs (11.6%), infusion reactions (4.7%), all Grade 1-2 except a Grade 3 skin AE (erythema nodosus). FFPE tumor samples collected at baseline (t0) and after chemotherapy before nivolumab (t1) were assessed by multiplex immunofluorescence for 18 patients (including 4 patients with pCR). At t0 and t1 pCR vs. non-pCR patients had higher CD3+/PD-1+ (p=0.010, p=0.001), CD4+/FOXP3+ (p=0.025, p=0.004) and CD68+/CD163+ (p=0.015, p=0.026) cells. CD8+ cells increased in pCR patients from t0 to t1 (p=0.001 for pCR vs. non-pCR at t1).


A neoadjuvant sequence of anthracycline chemotherapy and nivolumab (+ endocrine therapy) induced a 16.3% pCR rate in Luminal B breast cancer patients (primary endpoint not met). Liver toxicity accounted for most Grade >3 treatment-related AEs. Baseline and on-treatment characterization of immune infiltrate may identify patients more likely to respond. Residual cancer burden and updated biomaker data will be presented.

Clinical trial identification

EUDRACT 2016-004665-10.

Editorial acknowledgement

Legal entity responsible for the study

Department of Surgery, Oncology and Gastroenterology, University of Padova, Padua, Italy.


Bristol-Myers Squibb (financial support and drug).


M.V. Dieci: Advisory/Consultancy: Genomic Health; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Celgene. V. Guarneri: Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Eli Lilly; Advisory/Consultancy, Research grant/Funding (institution): Roche. A. Musolino: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Eli Lilly; Advisory/Consultancy: Pfizer; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Eisai; Advisory/Consultancy: Macrogenics; Research grant/Funding (institution): AstraZeneca. S. Spazzapan: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: Gentili; Advisory/Consultancy: Takeda; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Celgene; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Cell-dex therapeutics; Travel/Accommodation/Expenses: Tesaro; Travel/Accommodation/Expenses: Teva. P.F. Conte: Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Eli Lilly; Honoraria (self), Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Tesaro; Honoraria (self), Research grant/Funding (institution): BMS; Honoraria (self), Research grant/Funding (institution): Roche; Research grant/Funding (institution): Merck-Serono. All other authors have declared no conflicts of interest.

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