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Supplemental material, sj-docx-1-tam-10.1177_17588359221083956 for AMEERA-5: a randomized, double-blind phase 3 study of amcenestrant plus palbociclib versus letrozole plus palbociclib for previously untreated ER+/HER2��� advanced breast cancer by Aditya Bardia, Javier Cortes, Sara A. Hurvitz, Suzette Delaloge, Hiroji Iwata, Zhi-Ming Shao, Dheepak Kanagavel, Patrick Cohen, Qianying Liu, Sylvaine Cartot-Cotton, Vasiliki Pelekanou and Joyce O���Shaughnessy in Therapeutic Advances in Medical Oncology

BackgroundFor estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC), the current standard first-line treatment includes an aromatase inhibitor in combination with a cyclin-dependent kinase 4/6 inhibitor. When resistance occurs, often related to the occurrence of ESR1 mutations, selective estrogen receptor modulators or degraders (SERDs) may be used, alone or in combination regimens. Amcenestrant (SAR439859), an optimized oral SERD, has shown clinical antitumor activity in combination with palbociclib in patients with ER+/HER2- ABC and, as monotherapy, in patients with and without ESR1 mutations. Here, we describe the study design of AMEERA-5, an ongoing, prospective, phase 3, randomized, double-blind, multinational study comparing the efficacy and safety of amcenestrant plus palbociclib versus letrozole plus palbociclib in patients with advanced (locoregional recurrent or metastatic) ER+/HER2- breast cancer.MethodsPatients are pre-/postmenopausal women and men with no prior systemic therapy for ABC. The planned enrollment is 1066 patients. Patients are randomized 1:1 to either amcenestrant 200 mg plus palbociclib 125 mg or letrozole 2.5 mg plus palbociclib 125 mg. Amcenestrant, letrozole, and their matching placebos are taken once daily continuously; palbociclib is taken once daily for 21 days, followed by 7 days off-treatment for a 28-day cycle. Treatment continues until disease progression, unacceptable toxicity, or decision to stop treatment. Pre-/perimenopausal women and men receive goserelin subcutaneously. Randomization is stratified by de novo metastatic disease, menopausal status, and visceral metastases. The primary endpoint is progression-free survival. The key secondary endpoint is overall survival; others are safety, pharmacokinetics, and quality of life.ConclusionsAMEERA-5 is evaluating the efficacy and safety of amcenestrant in combination with palbociclib as first-line therapy in pre-/postmenopausal women and men with ER+/HER2- ABC.Clinicaltrials identifierNCT04478266.

Supplemental material, sj-docx-1-tam-10.1177_17588359221083956 for AMEERA-5: a randomized, double-blind phase 3 study of amcenestrant plus palbociclib versus letrozole plus palbociclib for previously untreated ER+/HER2��� advanced breast cancer by Aditya Bardia, Javier Cortes, Sara A. Hurvitz, Suzette Delaloge, Hiroji Iwata, Zhi-Ming Shao, Dheepak Kanagavel, Patrick Cohen, Qianying Liu, Sylvaine Cartot-Cotton, Vasiliki Pelekanou and Joyce O���Shaughnessy in Therapeutic Advances in Medical Oncology

Supplemental Material, 02_Suplemental_data_Final_060420 for Two Patient Studies of a Companion Diagnostic Immuno-Positron Emission Tomography (PET) Tracer for Measuring Human CA6 Expression in Cancer for Antibody Drug Conjugate (ADC) Therapy by Arutselvan Natarajan, Shyam M. Srinivas, Carmen Azevedo, Lacey Greene, Anne-Laure Bauchet, Erwan Jouannot, Anne-Sophie Lacoste-Bourgeacq, Isabelle Guizon, Patrick Cohen, Anne-Laure Naneix, Ohad Ilovich, Jordan Cisneros, Krithika Rupanarayan, Frederick T. Chin, Andrei Iagaru, Frederick M. Dirbas, Amer Karam and Sanjiv S. Gambhir in Molecular Imaging

We report the case of a patient suffering from a severe neologistic jargon sparing number words. Neologisms resulted from pervasive phoneme substitutions with frequent preservation of the overall syllabic structure (e.g. /revolver/ /reveltil/). Word and nonword reading, as well as picture naming, were equally affected. No significant influence of frequency, imageability, and grammatical class was found. In striking contrast with this severe speech impairment, the patient made virtually no phonological errors when reading aloud arabic or spelled-out numerals, but made frequentword selection errors (e.g. 250 "four hundred and sixty"). This observation indicates that during speech planning, different categories of words are processed by separable brain systems down to the level of phoneme selection, a more peripheral level than was previously assumed. Number words may be singled out during phonological processing either because they constitute a particular semantic category, or because they benefit from spec...