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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
GLORIA The GLORIA Study: A Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI 822)/OBI 821 in the Adjuvant  Treatment of Patients with High Risk, Early- Stage Globo H-Positive Triple Negative Breast Cancer Neg Neg Subcutaneous injection

No

 All patients will receive Standard of Care with or without study drug. You will know whether you are receiving study drug or not.
DESTINY A phase 3, multicenter, randomized, open-label, active-controlled study of trastuzumab deruxtecan (t-dxd) versus trastuzumab emtansine (t-dm1) in subjects with high-risk her2-positive primary breast cancer who have residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy.

(t-dxd vs. t-dm1 in high-risk her2-positive patients with residual invasive breast cancer following neoadjuvant therapy)

 Positive Either Intravenous

No

 Patients will receive either T-DXd or T-DM1

 

Locally Advanced or Metastatic Breast Cancer

Short Name Full title Her 2 HR Treatment Delivery Placebo? Notes
SILVERBACK A Phase 1/1b, open-label, dose escalation and expansion study of SBT6050 in subjects with advanced solid tumors expressing Her2 Positive Either Subcutaneous injection No All patients will receive SBT6050
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.
EMBER EMBER: A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination with Abemaciclib to Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers Either Pos Oral

(IV trastuzumab if applicable)

 No In Phase 1a part of study, all patients receive study drug alone.

In Phase 1b, there are three arms to the study. All participants will receive study drug with or without approved oral drugs or IV trastuzumab as applicable. You will know what treatment you are receiving.

 
HER2CLIMB-02 Randomized, Double-Blind, Phase 3 Study of Tucatinib or Placebo in Combination with Ado-Trastuzumab Emtansine (T DM1) for Subjects with Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02) Positive Either Intravenous (Ado-Trastuzumab Emtamsine) and oral (Tucatinib/placebo)

Yes

 All participants will receive Ado-Trastuzumab Emtansine with or without tucatinib
AMEERA-5 A randomized, multicenter, double-blind Phase 3 study of amcenestrant(SAR439859)plus palbociclib versus letrozole plus palbociclib for the treatment of patients with ER (+), HER2 (-) breast cancer who have not received prior systemic anti-cancer treatment for advanced disease Negative Positive

Oral (amcenestrant, palbociclib, letrozole) and subcutaneous (goserelin)

Yes

 All patients will receive palbociclib and goserelin. Patients will also receive oral letrozole (or its matching placebo) and amcenestrant (or its matching placebo) so that all patients are receiving Palbociclib plus one active drug and one placebo together with goserelin.