April Featured Clinical Trials

NSABP B-47

Disease: Breast

A Randomized Phase III Trial of Adjuvant Therapy comparing chemotherapy alone (Six Cycles of Docetaxel plus cyclophosphamide of four cycles of doxorubicin plus cyclophosphamide followed by weekly Paclitaxel) to chemotherapy plus Trastuzumab in Women with Node-Positive of High-Risk Node Negative HER2-Low invasive Breast Cancer.

Objective: The primary objective of this trial is to show that the addition of trastuzumab to chemotherapy (either TC [Groups 1A and 2A] or AC -> WP [Groups 1B and 2B]) improves IDFS. Patients will be entered in one of these two chemotherapy cohorts based on the investigators preference, which must be indicated prior to randomization

PFIZ 1912

Disease: Leukemia, Acute Myeloid (AML), Myelodysplastic Syndrome (MDS)

PFIZ 1912 – CC13-294: (B1371003) A phase 1b/2 study to evaluate the safety and efficacy of PF-04449913, an oral hedgehog inhibitor, in combination with intensive chemotherapy, low dose ara-c or decitabine in patients with AML or high-risk MDS

Objective: To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of PF-04449913 in combination with low dose Ara-C (LDAC; Arm A), decitabine (Arm B) or cytarabine/daunorubicin (Arm C) when administered to adults with previously untreated AML or high-risk MDS.

RTOG 1119

Disease: Brain, Breast

Phase II Randomized study of whole brain radiotherapy in combination with concurrent lapatinib in patients with brain metastasis from HER2-Positive Breast cancer. A collaborative study of RTOG and KROG.

Objective: To determine if there is a signal for an increase in complete response (CR) rate in the brain at 12 weeks post WBRT as determined by MRI scan of the brain, with the addition of lapatinib to WBRT compared to WBRT alone.