Abstract OT-26-02: Phase III open-label, multicenter, randomized trial of adjuvant palbociclib in combination with endocrine therapy versus endocrine therapy alone for patients with hormone receptor-positive / HER2-negative resected isolated locoregional recurrence of breast cancer - The POLAR Trial

2021 ◽  
Author(s):  
Elisabetta Munzone ◽  
Stefan Aebi ◽  
Noelia Martínez Jañez ◽  
Uwe Güth ◽  
Meritxell Bellet ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Trial ◽  
Endocrine Therapy ◽  
Hormone Receptor ◽  
Locoregional Recurrence ◽  
Phase Iii ◽  
Open Label ◽  
Multicenter Randomized Trial ◽  
Hormone Receptor Positive

The introduction of a third CDK4/6 inhibitor does not change the cost-effectiveness profile in first and subsequent-lines after progression or relapse during previous endocrine therapy in patients with hormone receptor positive (HR+)/human epidermal receptor-2 negative (HER-2) advanced or metastatic breast cancer

2020 ◽  
Vol 26 (6) ◽  
pp. 1486-1491
Author(s):  
Jacopo Giuliani ◽  
Andrea Bonetti
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Dose Reduction ◽  
Endocrine Therapy ◽  
Hormone Receptor ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Full Dose ◽  
Hormone Receptor Positive ◽  
Human Epidermal Receptor

The aim of this study was to assess the pharmacological costs of CDK4/6-inhibitors (palbociclib, ribociclib and abemaciclib) in hormone receptor positive (HR+)/human epidermal receptor 2-negative (HER2-) advanced or metastatic breast cancer (BC). We have considered pivotal phase III randomized controlled trials (RCTs) of palbociclib, ribociclib and abemaciclib for the treatment of postmenopausal women with HR+/HER2- advanced or metastatic BC in first-line in association with letrozole or anastrozole (scenario 1) and in subsequent-lines after progression or relapse during previous endocrine therapy (scenario 2).The costs of drugs are at the Pharmacy of our Hospital and are expressed in euros (€). Six phase III RCTs, including 3843 patients, were considered. In the scenario 1, abemaciclib resulted the less expensive at the full dose, with 2246 € per month of progression free survival (PFS)-gained. Overall ribociclib resulted the less expensive considering the reduction in dosage (36.1% in MONALEESA-2 trial versus (vs). 36.0% of palbociclib in PALOMA-2 trial vs. 43.4% of abemaciclib in MONARCH-3 trial). The price was the same for palbociclib and abemaciclib both at full and with dose reduction. In the scenario 2, the situation was similar to the scenario 1, but with lowest costs for ribociclib per month PFS-gained both at full dose (2070 €) and at dose reduction (1391 € and 690 € at 400 mg and 200 mg, respectively). Combining pharmacological costs of drugs with the measure of efficacy represented by the PFS, ribociclib was the less expensive in both scenarios.

scholarly journals Austrian Breast and Colorectal Cancer Study Group (ABCSG)

2006 ◽  
Vol 9 (S1) ◽  
pp. 5-25
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Hormone Receptor ◽  
Neoadjuvant Treatment ◽  
Distant Metastases ◽  
Adjuvant Endocrine Therapy ◽  
Phase Iii ◽  
Hormone Receptor Positive ◽  
Phase Iii Study ◽  
Positive Breast Cancer

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Austrian Breast and Colorectal Cancer Study Group ABCSG. Clinical trials include:Adjuvant therapy with CMF versus goserelin plus tamoxifen in pre-menopausal, hormone-responsive, lymph node-positive or -negative patients. Study 5Adjuvant endocrine therapy in postmenopausal patients with hormone-responsive breast cancer: tamoxifen versus tamoxifen plus aminoglutethimide. Study 6Pre and postoperative chemotherapy versus conventional adjuvant chemotherapy alone in patients presenting with hormone receptor-negative breast cancer. Study 7Adjuvant endocrine therapy in postmenopausal patients with hormone-responsive breast cancer, G1 and G2 (ARNO). Study 8Adjuvant chemotherapy in postmenopausal patients with hormone-responsive breast cancer, G3. Study 9Adjuvant endocrine therapy and bisphosphonate therapy: tamoxifen in comparison to anastrozole, alone or in combination with zoledronate, in premenopausal patients presenting with hormone-responsive, Stage I and II breast cancer. Study 12Effect of 3 versus 6 cycles of epidoxorubicin/docetaxel G-CSF upon the rate of complete pathological remissions in the neoadjuvant treatment of patients with primary breast cancer and no distant metastases. Study 14SALSA (Secondary Adjuvant Long-term Study with Arimidex): a prospective, randomized, open, multicentre Phase III study to assess the efficacy of secondary adjuvant endocrine anastrozole therapy for 2 further years versus 5 further years in patients with hormone receptor-positive breast cancer after a 5-year primary adjuvant endocrine therapy. Study 16Neoadjuvant hormonal therapy with exemestane in postmenopausal patients with primary hormone receptor-positive breast cancer and no distant metastases. Study 17A randomized, double-blind, placebo-controlled, multi-centre phase 3 study to determine the treatment effect of denosumab in subjects with non-metastatic breast cancer receiving aromatase inhibitor therapy. Study 18A randomised Phase II study comparing anastrozole and fulvestrant to anastrozole for adjuvant treatment of postmenopausal patients with early breast cancer and disseminated tumour cells in bone marrow. Study 21A randomized Phase III study comparing epirubicin, docetaxel and capecitabine G-CSF to epirubicin and docetaxel G-CSF as neoadjuvant treatment for early HER-2 negative breast cancer and comparing epirubicin, docetaxel and capecitabine G-CSF trastuzumab to epirubicin and docetaxel G-CSF trastuzumab as neoadjuvant treatment for early HER-2 positive breast cancer. Study 24

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