
T-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer
Metastatic Breast CancerThis open-label, single-center Phase Ib study will assess the safety and tolerability of combining trastuzumab emtansine (T-DM1) with Lapatinib and Abraxane in patients with metastatic HER2-positive breast cancer.

STAR Cape+BKM120 MBC With Brain Met
Brain MetastasesBreast Cancer1 moreThis is a study to determine the safety and effectiveness of BKM120 plus capecitabine in breast cancer patients with brain metastases. Both capecitabine and BMK120 have previously shown activity in patients with breast cancer. Like capecitabine, BMK120 is also effective in crossing the blood brain barrier making it a preferred candidate for its evaluation in patients with metastatic breast cancer (MBC).

Additional 4 Cycles of Cisplatin (CDDP4) in Patients With Triple Negative Breast Cancer for Neoadjuvant...
Breast CancerAchievement of pathologic complete response is important prognosticator to predict long term outcome in triple negative cancer. The efficacy of adding 4 cycles of cisplatin (CDDP4) is to be investigated whether addtional pathologic complete response is achieved for those triple negative breast cancer patients who recieved 4 cycles of adriamycin with cyclophosphamide(AC4) but did not reach clinical complete response during the course of neoadjuvant therapy.

A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants...
Breast NeoplasmsThis multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors.

A Phase III Trial Comparing Two Dose-dense, Dose-intensified Approaches (ETC and PM(Cb)) for Neoadjuvant...
Tubular Breast Cancer Stage IITubular Breast Cancer Stage III5 moreTwo regimen are currently considered to have highest efficacy for patients with high-risk early stage breast cancer: sequential treatment of high dose epirubicin, taxane, and cyclophosphamide concomitantly with a dual HER2-blockade, and weekly treatment with paclitaxel/non-pegylated liposomal doxorubicin with dual HER2-blockade or carboplatin. The aim of the GeparOcto study is to compare those two regimen/strategies. Both regimens are myelosuppressive with a significant incidence of chemotherapy induced anaemia. The second aim of the GeparOcto study is therefore to compare the use of parental ferric carboxymaltose versus physician's choice for the treatment of chemotherapy-induced anemia in patients with iron deficiency.

PAM50 HER2-enriched Phenotype as a Predictor of Response to Dual HER2 Blockade in HER2-positive...
Breast CancerNon-randomized, open label, multicentric translational research study in women with untreated invasive breast carcinoma eligible for primary surgery (Stage I-IIIA). The aim of PAMELA is to test the hypothesis that PAM50 HER2-enriched (HER2-E) subtype better predicts response to neoadjuvant dual anti-HER2 blockade, with or without endocrine therapy, compared to traditional clinical HER2 classification. Furthermore, we posit that characterization of gene expression patterns may identify profiles of those who may be safely spared chemotherapy.

Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to...
Metastatic Breast CancerThis is an international (4 countries) randomized phase III study with 2 cohorts, patients will be randomized 1:1 to endocrine therapy (cohort 1: exemestane 25 mg daily, cohort 2: fulvestrant 500mg days 1 and 15 cycle 1 and then day 1 every 4 weeks) plus palbociclib (125 mg daily x3 weeks every 4 weeks) vs. capecitabine (1,250 mg/m2 twice daily x2 weeks every 3 weeks). Postmenopausal patients with HR+/HER2 MBC are eligible if resistant to previous nonsteroidal aromatase inhibitors (NSAI) (letrozole or anastrozole) in cohort 1 or previous aromatase inhibitors (AI) (letrozole, anastrozole or exemestane) in cohort 2 defined as: recurrence while on or within 12 months after the end of adjuvant treatment with NSAI/AI or progression while on or within 1 month after the end of treatment with NSAI/AI for MBC. Previous chemotherapy is permitted either in the (neo)adjuvant setting and/or as first line for MBC. Patients must have measurable disease according to RECIST 1.1 or bone lesions, lytic or mixed, in the absence of measurable disease.

Viral Therapy In Treating Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head...
Estrogen Receptor NegativeEstrogen Receptor Positive9 moreThis phase I trial studies the side effects and the best dose of viral therapy in treating patients with squamous cell carcinoma of the head and neck that has returned (come back) after a period of improvement or has spread to other parts of the body or breast cancer that has spread to other parts of the body. A virus called encoding thyroidal sodium iodide symporter, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells.

Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors
Breast CancerStage II Breast Cancer1 moreThis phase II trial studies how well exemestane before surgery works in treating postmenopausal patients with newly diagnosed estrogen receptor positive stage II-III breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells.

A Pilot Study Utilizing Proteomic and Genomic Profiling for Patients With Metastatic Breast Cancer...
Metastatic Breast CancerThis study will use proteomic and genomic profiling to analyze tumor tissue to see if treatment selected by this analysis will benefit patients.