Clinical Trials Actively Recruiting

Primary Objectives:

• To evaluate the safety and tolerability of FT825 with or without cetuximab following CY/FLU or bendamustine
• To define the RP2D of FT825 with or without cetuximab following CY/FLU or bendamustine

Secondary Objectives:

• To evaluate the antitumor activity of FT825 with or without cetuximab following CY/FLU or bendamustine
• To characterize the PK of FT825 with or without cetuximab following CY/FLU or bendamustine

Primary Objective:

• To evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.

Secondary Objectives:

• To evaluate whether breast conservation surgery and endocrine therapy inclusive of any second breast conservation surgery for salvage of IBTR results in a non-inferior rate of overall breast conservation compared to breast conserving surgery, endocrine therapy and radiation for IBTR.
• To evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive ipsilateral breast tumor recurrence (IIBTR) compared to breast conservation, breast radiation, and endocrine therapy.
• To evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior relapse free interval (RFI) compared to breast conservation, breast radiation, and endocrine therapy.
• To evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior distant disease-free survival(DDFS) compared to breast conservation, breast radiation, and endocrine therapy.
• To evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior overall survival (OS) compared to breast conservation, breast radiation, and endocrine therapy.
• To evaluate whether there is a difference in patient-reported breast pain in women who do and do not receive breast radiation.
• To evaluate whether there is a difference in patient-reported worry about recurrence in women who do and do not receive breast radiation.
• To evaluate whether adherence to endocrine therapy following breast conservation surgery alone is non inferior compared to endocrine therapy with breast conservation surgery and breast radiation.

Primary Objective

• To estimate the negative predictive value (NPV) of niFDG-PET/CT for pCR, using ΔSULmaxD15, completed through central review, of the primary breast cancer at a threshold of 40%, in patients treated with neoadjuvant HER2-directed therapy.

Secondary Objectives

• To estimate the sensitivity, specificity, and positive predictive value (PPV) of niFDG-PET/CT for pCR, using ΔSULmaxD15 of the primary breast cancer at a threshold of 40%, in patients treated with neoadjuvant HER2-directed therapy.
• To evaluate the performance of niFDG-PET/CT, using ΔSULmaxD15 of the primary breast cancer at a threshold of 40%, as a predictor of 3-year event-free survival (EFS) from time of study registration.

Primary Objective:

• To assess whether participants with early stage TNBC randomized to receive
  anthracycline-free, taxane-platinum neoadjuvant chemotherapy with
  pembrolizumab have non-inferior breast cancer event-free survival (BC-EFS)
  compared to participants randomized to taxane-platinum-anthracycline
  neoadjuvant chemotherapy with pembrolizumab.

Secondary Objectives:

• To compare pathological complete response (pCR) and residual cancer burden
  (RCB) rates by randomized arm.
• To compare pCR and RCB rates between randomized arms by tumor infiltrating
  lymphocytes (TIL) status.
• To compare BC-EFS between randomized arms in the TIL-enriched and non-TIL
  enriched subgroups.
• To compare distant relapse-free survival and overall survival by randomized arm.
• To compare invasive breast cancer-free survival after surgery between
  randomized arms in pCR and residual disease groups.
• To compare the safety and tolerability by randomized arm among those that initiate
  therapy.

Primary Objective:

• To compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not, defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC.

Secondary Objectives:

• To compare the invasive disease-free survival (DFS) between patients that received regional RT or not.
• To compare the breast cancer mortality between patients that received regional RT or not.
• To compare the overall survival (OS) between patients that received regional RT or not.
• To compare the locoregional recurrence-free interval (LRRFI) between patients that received regional RT or not.
• To compare the distant recurrence-free interval (DRFI) between patients that received regional RT or not.
• To compare the toxicity between patients that received regional RT or not.
• To compare arm volume and mobility measurements between patients that received regional RT or not.
• To compare patient reported outcomes (PROs) and the quality of life (QOL) between patients that received regional RT or not.
• To compare the cost effectiveness between patients that received regional RT or not.

Primary objective:

• To determine if the iDFS with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-directed therapy.

Secondary objectives:

• To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with TDM1 alone (T-DM1 plus placebo) improves the following:
  
  • overall survival (OS)
  • breast cancer free survival (BCFS)
  • distant recurrence-free survival (DRFS)
  • disease-free survival (DFS)
  • brain metastases-free survival (BMFS).
• To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with TDM1 alone (T-DM1 plus placebo) reduces the incidence of brain metastases.

Primary Objective:

• To compare the proportions of participants in the Tomosynthesis (TM) and Digital Mammography (DM) study arms experiencing the occurrence of an "advanced" breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen (T4). For purposes of this study, "advanced" cancers are those meeting any of the following criteria at any time during a period of 4.5 years from randomization:
• there are distant metastases,
• there are positive lymph nodes*,
• the cancer is invasive and is greater than or equal to 20 mm in size, or
• the cancer is invasive and is greater than 10 mm and less than 20 mm in size and is either: 1) ER- and PR- and HER2-, or is 2) HER2+.

*lymph nodes with micrometastases (none greater than 2 mm) and/or isolated tumor cells are not considered lymph node positive for definition of advanced cancer. All cancers that meet these criteria that present within 4.5 years of randomization will be counted in the primary endpoint.

Secondary Objectives:

• To assess the potential effect of age, menopausal and hormonal status, breast density, and family cancer history on the primary endpoint difference between the two arms.

Primary Objective:

• Determine the maximum tolerated dose
  (MTD) and the recommended Phase 2
  dose (RP2D) of KSQ-4279 alone and in
  combination in patients with advanced
  solid tumors

Secondary Objectives:

• Assess the safety and tolerability of
  KSQ-4279 alone and in combination in
  patients with advanced solid tumors
• Characterize the PK profile of KSQ-
  4279 alone and in combination in
  patients with advanced solid tumors
• Evaluate preliminary antitumor activity
  of KSQ-4279 alone and in combination
  in patients with advanced solid tumors

Primary Objectives:

• To evaluate the safety and tolerability of SGN-PDL1V in subjects with advanced solid tumors.
• To identify the maximum tolerated dose (MTD) of SGN-PDL1V in subjects with advanced solid tumors.
• To identify a recommended dose and schedule for SGN-PDL1V.

Secondary Objectives:

• To assess the antitumor activity of SGN-PDL1V.
• To assess the pharmacokinetics (PK) of SGN-PDL1V.
• To assess the immunogenicity of SGN-PDL1V.

Primary Objectives:

• To evaluate the safety and tolerability of BS006 in patients with advanced solid tumors
• To estimate the maximum tolerated dose (MTD) of BS006

Secondary Objectives:

• To preliminarily observe the anti-tumor efficacy of BS006 in patients with advanced solid tumors
• To evaluate the biological activities of BS006 in tumor
• To evaluate the biodistribution and viral shedding of BS006