Treating Patients with Hormone Receptor Positive, HER2 Positive Operable or Locally Advanced Breast Cancer

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1 Breast Studies Adjuvant therapy after surgery Her 2 positive Breast Cancer B 52 Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients with Hormone Receptor Positive, HER2 Positive Operable or Locally Advanced Breast Cancer This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work compared to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone receptor positive, human epidermal growth factor receptor 2 (HER2) positive, operable or locally advanced breast cancer. Drugs used In chemotherapy, such as docetaxel, carboplatin, trastuzumab, and pertuzumab, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high energy X rays to kill tumor cells. Giving combination chemotherapy and radiation therapy with or without hormone therapy may be an effective treatment for hormone receptor positive, HER2 positive, operable or locally advanced breast cancer. Triple negative breast cancer B 55 Olaparib as Adjuvant Treatment in Patients with Germline BRCA Mutated High Risk HER 2 Negative Primary Breast Cancer Olaparib treatment in patients with germline BRCA 1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy Hormone receptor positive breast cancer S1007 Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive, Node Positive, Endocrine Responsive Breast Cancer This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by

2 stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving tamoxifen, anastrozole, letrozole, or exemestane is more effective with combination of chemotherapy in treating patients with breast cancer. S1207 Hormone Therapy With or Without Everolimus in Treating Patients with Breast Cancer Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether hormone therapy is more effective when given with or without everolimus in treating breast cancer. Adjuvant radiation B51 Standard or Comprehensive Radiation Therapy in Treating Patients with Early Stage Breast Cancer Previously Treated With Chemotherapy and Surgery This randomized Phase III trial studies standard or comprehensive radiation therapy in treating patients with early stage breast cancer who have undergone surgery. Radiation therapy uses high energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer. Metastatic breast cancer CellDex( CDX 011) Study of Glembatumumab Vedotin (CDX 011) in Patients with Metastatic, gbnmb Over Expressing, Triple Negative Breast Cancer (The Metric Study) The main purpose of this study is to see whether CDX 011 (glembatumamub Vedotin, an antibody drug conjugate) is effective in treating patients who have advanced Triple Negative Breast Center (TNBC; i.e. tumors lacking expression of estrogen, progesterone and HER2 receptors), and whose tumor cells make a protein called glycoprotein NMB (gpnmb), which CDX 011 binds to. The study will also further characterize the safety of CDX 011 treatment in the patient population. Symptom Management S1202 Duloxetine Hydrochloride to Treat Muscle, Bone, and Joint Pain in patient with Early Stage Breast Cancer Receiving Hormone Therapy

3 Duloxetine hydrochloride may lessen muscle, bone and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy. This randomized phase III trial studies how well duloxetine works compared to a placebo in treating muscle, bone, and joint pain in patients with early stage breast cancer receiving hormone therapy.

4 COlON STUDIES C80702 Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin,leucovorin calcium, and fluorouracil is more effective with or without celecoxib in treating colon cancer. This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery. KIDNEY STUDIES S0931 Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery Everolimus may stop growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery. Esophageal Studies S1201 Combination Chemo for Patients With Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer This randomized phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating patients with esophageal cancer, gastric cancer, or gastroesophageal junction cancer.

5 Multiple Myeloma E1A11 Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well it works compared to carfilzomib, lenalidomide, dexamethasome in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib or carfilizomib together with lenalidomide and dexamethasone may kill more cancer cells. LUNG STUDIES PPHM 1202 Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late Stage Non squamous Non small cell Lung Cancer The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for nonsmall cell lung cancer. CFZ004 Phase 1/b Study of Carfilzomib, Carboplatin, and Etoposide in Subjects With Previously Untreated Extensive Stage Small cell Lung Cancer The purpose of this study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of carfilzomib given in combination with carboplatin and etoposide as initial therapy for subjects with Extensive Stage Small Cell Lung Cancer (ES SCLC)

6 MK-3475/Keynote 24 Study - Study of Pembrolizumab (MK-3475) Compared to Platinum Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer This is an efficacy and safety study to assess pembrolizumab (MK-3475/SCH ) compared to standard of care (SOC) platinum-based chemotherapies in the treatment of participants with previously untreated stage IV, programmed cell death ligand 1 (PD-L1) strong expressing Non-Small Cell Lung Cancer( NSCLC). The primary hypothesis of this study is that the participants will have a longer Progression Free Survival (PFS), as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) when treated with pembrolizumab than when treated with platinum based chemotherapies.

7 PROSTATE STUDIES A Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration Resistant Metastatic Prostate Cancer This randomized phase III trial studies enzalutamide to see how well it works with compared to enzalutamide, abiraterone, and prednisone in treating patients with castration resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.

8 S1400 Biomarker Targeted Second Line Therapy in Treating Patients With Recurrent Stage IIIB IV Squamous Cell Lung Cancer This screening and multi sub study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi sub study Master Protocol. The type of cancer trait (biomarker) will determine to which substudy, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a non match sub study which will include all screened patients not eligible for any of the biomarker driven sub studies. This sub study will compare a non match therapy to standard of care also with goal of approval. LEUKEMIA A Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia This randomized Phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether rituximab with bendamustine hydrochloride is more effective then rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocyctic leukemia.

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