Breast: Metastatic Clinical Trials

Showing 31-39 of 39 items
  • Phase I Dose Escalation Study With an Allosteric AKT 1/2 Inhibitor in Patients
  • This is the first study where BAY1125976 is given to humans. Patients (all comers) will receive the study drug treatment in a dose-escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY1125976. The relative bioavailability of liquid service formulation and tablets will be determined. After the MTD is defined breast cancer patients with and without AKT1 mutation will be treated. The study will also assess the pharmacokinetics, biomarker status, pharmacodynamic parameters and tumor response of BAY1125976. BAY1125976 will be given daily as single oral application. Treatment will be stopped if the tumor continues to grow, if side effects, which the patient cannot tolerate, occur or if the patient decides to exit treatment.
  • Diagnoses: Breast: Metastatic, Solid Tumor/Phase I
  • Status: Recruiting
  • Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer
  • This is a multicenter, open-label, Phase II study in subjects with Human epidermal growth factor receptor (HER2)-positive metastatic breast cancer who received at least 2 prior lines of anti-HER2-targeted therapies of which at least one included a Trastuzumab-containing regimen. This study is a post-approval commitment with regulatory authorities. It is designed with the primary endpoint to evaluate the changes in biomarkers associated with HER family, immunomodulation, apoptosis, and Adenosine triphosphate binding cassette (ABC) transporters between the pre-treatment and disease progression biopsy. It is hypothesized that these changes in biomarkers may modulate resistance mechanisms and thereby alters the response to subsequent chemotherapy based regimens. Therefore, in addition to the description of the clinical outcome of Overall response rate, Clinical benefit rate, Progression-free survival and Overall survival for each arm, Progression-free survival on next-line therapies will be collected and summarized for each arm. All subjects will receive study treatment until disease progression, unacceptable toxicity, or subject withdrawal, and after which, will be followed for subsequent anticancer therapy and disease progression events, and survival. The primary endpoint of the study will be to evaluate changes in expression of biomarkers associated with the HER family or receptors and ligands, immunomodulation, apopotsis, and ABC transports between a pre-treatment biopsy and the disease progression biopsy. This study will evaluate potential mechanisms to explore the antitumor activity of dual blockade and will provide a descriptive clinical outcome for subjects treated with Trastuzumab in combination with Lapatinib or chemotherapy. No formal comparisons between treatment arms will be undertaken.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
  • Study of SRN-927 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
  • This is an open-label, dose-finding study of SRN-927 administered orally on a continuous daily dosing regimen with a PK lead-in period (dose escalation period only). The incidence of dose limiting toxicity (DLT) will be evaluated from Day -7 through the first cycle (28 days) of treatment (35 days total). Depending on safety and tolerability, patients will be assigned sequentially to escalating doses of SRN-927 using standard 3+3 design. All patients will be treated until disease progression, unacceptable toxicity, or patient withdrawal of consent.
  • Diagnoses: Breast: Metastatic
  • Status: Recruiting
Showing 31-39 of 39 items
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