Background: In the neoadjuvant setting, blockade of HER2 plus use of an aromatase inhibitor in patients with HER2-positive and oestrogen receptor (ER)-positive breast cancer leads to a pathological complete response in 21% of patients. Convergence of HER2 and ER signals on RB1 suggests that a combined pharmacological intervention directed to...
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2018 (v1)PublicationUploaded on: April 14, 2023
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2019 (v1)Publication
Dose-dense adjuvant chemotherapy is standard of care in high-risk early breast cancer patients. However, its role in HER2-positive patients is still uncertain. In this exploratory analysis of the GIM2 trial, we investigated the efficacy of dose-dense chemotherapy in HER2-positive breast cancer patients with or without exposure to trastuzumab....
Uploaded on: April 14, 2023 -
2021 (v1)Publication
The GIM2 phase III trial demonstrated the benefit of dose-dense chemotherapy in node-positive early breast cancer (eBC). To better define the dose-dense effect in the hormone receptor-positive subgroup, we evaluated its benefit through a composite measure of recurrence risk. We conducted an ancillary analysis of the GIM2 trial evaluating the...
Uploaded on: March 27, 2023 -
2024 (v1)Publication
Background: Most premenopausal patients with early breast cancer (eBC) are diagnosed with hormone receptorpositive disease and therefore candidate for adjuvant endocrine therapy (ET). Patients and methods: The Gruppo Italiano Mammella (GIM) 23-POSTER (GIM23) is a multicenter, prospective, observational study conducted in 26 Italian...
Uploaded on: August 15, 2024 -
2024 (v1)Publication
Background: Intermediate clinical endpoints (ICEs) are frequently used as primary endpoint in randomised trials (RCTs). We aim to assess whether changes in different ICEs can be used to predict changes in overall survival (OS) in adjuvant breast cancer trials. Methods: Individual patient level data from adjuvant phase III RCTs conducted by the...
Uploaded on: July 3, 2024 -
2021 (v1)Publication
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Uploaded on: April 14, 2023 -
2022 (v1)Publication
Background: Previous analyses of the GIM (Gruppo Italiano Mammella) 2 study showed that addition of fluorouracil to epirubicin, cyclophosphamide, and paclitaxel in patients with node-positive early breast cancer does not improve outcome, whereas dose-dense chemotherapy induces a significant improvement in both disease-free survival and overall...
Uploaded on: February 7, 2024 -
2023 (v1)Publication
Background: Prior exposure to adjuvant endocrine therapy (ET) and timing to recurrence are crucial factors for first-line treatment choices in patients with hormone receptor-positive/HER2-negative (HR+/HER2-) breast cancer (BC) and in clinical trial eligibility, classifying metastatic HR+/HER2- BC as endocrine sensitive (ES) or primary...
Uploaded on: February 4, 2024 -
2023 (v1)Publication
Purpose: In estrogen receptor-positive (ER+) breast cancer (BC), single-nucleotide polymorphisms (SNPs) in the aromatase gene might affect aromatase inhibitors (AIs) metabolism and efficacy. Here, we assessed the impact of SNPs on prognosis and toxicity of patients receiving adjuvant letrozole. Experimental design: We enrolled 886...
Uploaded on: February 14, 2024 -
2023 (v1)Publication
Simple Summary Breast cancer is one of the most common oncological diseases among women in Western Countries and Italy as well. GIM 13-AMBRA is a patient journey study regarding how the prognosis of metastatic breast cancer patients has changed in the last decades as a result of the introduction of new drugs in clinical practice. This study...
Uploaded on: February 14, 2024