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Pharmaceutical Clinical Trials

Current Pharmaceutical Clinical Trials

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Early Breast Cancer

Short Name Full title HER 2 HR Treatment Delivery Placebo? Notes
CA209 7A8 Randomized, Non-comparative Neoadjuvant Phase II Study in Postmenopausal Women with Stage II-III, ER+/HER2- Breast Cancer with Safety Run-in, Assessing Nivolumab + Abemaciclib or Palbociclib + Anastrozole Negative Positive Combination of Oral and intravenous No All patients receive oral drugs Palbociclib and Anastrazole with or without addition of IV Nivolumab.
NATALEE “A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE). Negative Positive Oral No All patients receive oral endocrine therapy with or without oral drug ribociclib

 

Locally Advanced or Metastatic Breast Cancer

Short Name Full title Her 2 HR Treatment Delivery Placebo? Notes
Contessa3 A Multicenter, Phase 2 Study of Tesetaxel plus Three Different PD-(L)1 Inhibitors in Patients with Triple-Negative, Locally Advanced or Metastatic Breast Cancer and Tesetaxel Monotherapy in Elderly Patients with HER2 Negative, Locally Advanced or Metastatic Breast Cancer Negative Negative Oral drug with or without intravenous No For previously untreated locally advanced or 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 Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy after Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer Positive Positive Oral, intravenous, intramuscular injection (IMI) if indicated No All patients receive anti-HER2 therapy and endocrine therapy
(either oral or injection) with or without addition of oral Palbociclib.
ACT16105 An open-label randomized Phase 2 trial of SAR439859, versus endocrine monotherapy as per physician’s choice in premenopausal and postmenopausal patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer with prior exposure to hormonal therapies Negative Positive Oral, intramuscular injection (IMI) if indicated No Patients will either receive new oral drug alone or endocrine therapy (either oral or IMI) alone.
EPIK A Phase III, multicenter, randomized, double-blind, placebo-controlled study of alpelisib (BYL719) in combination with
nab-paclitaxel in patients with advanced triple negative breast cancer with either phosphoinositide-3-kinase catalytic subunit alpha (PIK3CA) mutation or phosphatase and tensin homolog protein (PTEN) loss without PIK3CA mutation (H12301)		 Negative Negative Intravenous Yes All patients will receive nab-paclitaxel, an approved treatment in this setting, 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.