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Home > "Breast Cancer"

Protocol FM-14-B02 (EudraCT No. 2014-005017-23)

Recruiting

Neo-Adjuvant study with the PDL1-directed antibody in Triple Negative Locally Advanced Breast Cancer undergoing treatment with nabpaclitaxel and carboplatin – NeoTRIP (Neoadjuvant therapy in triple negative breast cancer with antiPDL1).

Click here to download the summary of the study.pdf

Protocol FM-14-B01 (EudraCT No. 2014-001984-11)

Recruiting

Neo-Adjuvant Treatment with the CDK4,6 inhibitor Palbociclib in HER2-positive and ER-positive breast cancer: effect on Ki67 and apoptosis before, during and after treatment – NAPHER2

Pubblications:

Gianni_L_et al_Lancet Oncol_2018

Pivot X_Cox DG_(Editorial)_Lancet Oncol_2018

Protocol FM-12-B01 (EudraCT N. 2012-003481-41)

Enrollment Completed
Neoadjuvant chemotherapy with nab-paclitaxel in women with HER2-negative high-risk breast cancer. ETNA (Evaluating Treatment with Neoadjuvant Abraxane)
Pubblications:

Gianni L_et al_JAMA Oncol_2018

Sparano_JA_(Editorial)_JAMA Oncol_2018

Protocol ECTO II FMB04-01 (EudraCT N. 2004-004957-24)

Enrollment Completed
European Cooperative Study of primary systemic therapy in women with operable breast cancer and T > 2 cm.
 
Pubblications
• Zambetti M_Breast Cancer Res Treat_2011_132(3) 843-51.pdf

Observational study FMB06-01, Ida Caterini

Enrollment Completed
Observational study on adjuvant systemic therapy in elderly women (≥70 years).

HERA Study

Enrollment Completed
A randomized, open-label, two-arm phase III study of the efficacy, safety and tolerability of Herceptin® compared to observation alone in women who have completed standard adjuvant systemic treatment for HER-2 positive primary breast cancer.

Protocol NOAH

Enrollment Completed
A multicenter, randomized, controlled, open labeled trial of paclitaxel containing chemotherapy (AT & T) followed by CMF versus the same chemotherapy plus Herceptin® in women with locally advanced breast cancer and HER2/c-erbB-2 overexpression and amplification, with a parallel observational study of the same chemotherapy regimen alone, in patients with HER2 negative tumors (0 or 1+ by immunohistochemistry).

 

Pubblications
• Gianni_L_Lancet-Oncol_2014_doi_10.1016_S1470-20451470080-4.pdf
• Semiglazov_V_Eur_J_Surg_Oncol_2011_37(10)_856-63.pdf
• Gianni_L_Lancet_2010_3_5_377_384.pdf

Protocol GMB/99/02

Enrollment Completed
Prospective randomized study of sequential adjuvant/primary chemotherapy in operable breast cancer.

Protocol GMB/99/01

Enrollment Completed
Prospective randomized study of standard vs high-dose chemotherapy in patients with metastatic or locally advanced breast cancer.

Protocol GMB97/01

Enrollment completed
Prospective randomized study of sequential adjuvant chemotherapy with epirubicin in operable breast cancer with 1 to 3 positive nodes.

Protocol ECTO I

Enrollment Completed
European Cooperative Study of chemotherapy and surgery comparing adjuvant doxorubicin followed by CMF vs adjuvant doxorubicin/paclitaxel followed by CMF vs primary doxorubicin/paclitaxel followed by CMF in women with operable breast cancer and T > 2 cm.

Protocol HDS GMB93/01b

Enrollment Completed
Prospective randomized study with high-dose chemotherapy in patients with operable breast cancer and > 3 positive axillary nodes.

Protocollo FMB07-01 (EudraCT N. 2007-001416-23)

Arruolamento Concluso
Studio multicentrico randomizzato, in doppio cieco, di fase IIb, per valutare l’efficacia e la tollerabilità dì sorafenib rispetto a placebo quando somministrato con chemioterapia e/o ormonoterapìa in pazienti con carcinoma mammario localmente recidivato o metastatico.

Protocol 9009 GMB93/01a

Enrollment Completed
Primary chemotherapy with epirubicin in operable breast cancer >2.5 cm.

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