Current Pharmaceutical Clinical Trials

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Early

Short Full title HER 2 HR Treatment Placebo? Notes Name Delivery

CA209 7A8 Randomized, Non-comparative Neoadjuvant Phase II Study in Negative Positive Combination No All patients Postmenopausal Women with Stage II-III, ER+/HER2- Breast Cancer with of Oral and receive oral Safety Run-in, Assessing Nivolumab + or + intravenous drugs Anastrozole Palbociclib and Anastrazole with or without addition of IV Nivolumab. PUMA6201 An Open-Label Study to Characterize the Incidence and Severity of Positive Either Oral No Patients are Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with given a Neratinib and Intensive Loperamide Prophylaxis management plan, including supportive medication measures, to assess the impact and frequency of the common side effect of diarrhoea associated

with this approved drug. NATALEE "A phase III, multicenter, randomized, open-label trial to evaluate efficacy Negative Positive Oral No All patients and safety of with endocrine therapy as an adjuvant treatment receive oral in patients with hormone receptor-positive, HER2-negative, early breast endocrine cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE). therapy with or without oral drug ribociclib

Locally Advanced or Metastatic Breast Cancer

Short Full title Her 2 HR Treatment Placebo? Notes Name Delivery

Contessa3 A Multicenter, Phase 2 Study of Tesetaxel plus Three Different PD-(L)1 Negative Negative Oral drug No For previously Inhibitors in Patients with Triple-Negative, Locally Advanced or with or untreated Metastatic Breast Cancer and Tesetaxel Monotherapy in Elderly without locally Patients with HER2 Negative, Locally Advanced or Metastatic Breast intravenous advanced or Cancer metastatic breast cancer. Two different cohorts (groups), those under 65 years of age and those 65 years or older. In the group under age 65, patients

will receive new oral drug with one of three approved immonutherapy drugs. Patients 65 years and over will receive only the new oral drug. PATINA A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Positive Positive Oral, No All patients Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. intravenous, receive anti- Anti-HER2 Therapy + Endocrine Therapy after Induction Treatment for intramuscular HER2 therapy Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast injection and endocrine Cancer (IMI) if therapy (either indicated oral or injection) with or without addition of oral Palbociclib. ACT16105 An open-label randomized Phase 2 trial of SAR439859, versus Negative Positive Oral, No Patients will endocrine monotherapy as per physician’s choice in premenopausal intramuscular either receive and postmenopausal patients with estrogen receptor-positive, HER2- injection new oral drug negative locally advanced or metastatic breast cancer with prior (IMI) if alone or exposure to hormonal therapies indicated endocrine therapy (either oral or IMI) alone. EPIK A Phase III, multicenter, randomized, double-blind, placebo-controlled Negative Negative intravenous Yes All patients will study of (BYL719) in combination with nab- in receive nab- patients with advanced triple negative breast cancer with either paclitaxel, an phosphoinositide-3-kinase catalytic subunit alpha (PIK3CA) mutation approved treatment in

or phosphatase and tensin homolog protein (PTEN) loss without this setting, PIK3CA mutation (H12301) with oral alpelisib or alpelisib plus placebo. Patients’ tumour tissue is first tested at a central study laboratory for specific cancer cell characteristics. Tissue is sent from previous biopsy or surgery if possible, or new biopsy if required.