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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Standard or Comprehensive Radiation Therapy in Treating Patients with Early-Stage Breast Cancer Previously Treated with Chemotherapy and Surgery

Breast

This randomized phase III trial studies radiation therapy to the breast, chest wall and lymph nodes (comprehensive) compared to standard radiation therapy to the breast in treating patients with early-stage breast cancer previously treated with chemotherapy and 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 early-stage breast cancer.
Breast
III
Chak, Bapsi
NCT01872975
NRGBREB-51

Fulvestrant or Exemestane with or without Ribociclib in Patients with Recurrent, Unresectable, or Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer

Breast

This randomized, phase II trial studies how well fulvestrant or exemestane with or without ribociclib works in treating patients with hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer that has progressed after treatment with an aromatase inhibitor or cyclin-dependent kinase 4 / 6 inhibitor (recurrent), cannot be removed by surgery (unresectable), or has spread to other parts of the body (metastatic). Hormone therapy using fulvestrant or exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fulvestrant or exemestane with ribociclib may be an effective treatment for patients with breast cancer.
Breast
II
Mayer, Ingrid
NCT02632045
VICCBRE15147

Tamoxifen Citrate or Letrozole with or without Palbociclib in Treating Patients with Stage I-III Invasive Breast Cancer before Surgery

Breast

This phase II clinical trial studies how well tamoxifen citrate or letrozole with or without palbociclib work in treating patients with stage I-III invasive breast cancer before surgery. Antihormone therapies, such as tamoxifen citrate and letrozole, may lessen the amount of estrogen made by the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving tamoxifen citrate or letrozole with or without palbociclib may work better in treating patients with stage I-III invasive breast cancer.
Breast
II
Mayer, Ingrid
NCT02764541
VICCBRE1732

Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors

Multiple Cancer Types

The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses.
Breast, Endocrine, Esophageal, Gastrointestinal, Lung, Non Small Cell, Pancreatic
I
Horn, Leora
NCT03102320
VICCPHI1742

Cisplatin, Romidepsin and Nivolumab in Treating Patients with Locally Recurrent or Metastatic Triple Negative Breast Cancer

Breast

This phase I / II trial studies the side effects and best dose of romidepsin when given together with cisplatin and nivolumab, to see how well they work in treating patients with triple negative breast cancer that has come back at or near the same place as the original (primary) tumor, usually after a period of time during which the cancer could not be detected or spread to other parts of the body. Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Romidepsin may also help cisplatin work better. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving romidepsin together with cisplatin and nivolumab may be a better treatment for tripe negative breast cancer.
Breast
I/II
Abramson, Vandana
NCT02393794
VICCBRE1674

Fulvestrant, Palbociclib, and pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Treating Patients with Estrogen Receptor Positive, HER2 Negative, and FGFR Amplified Stage IV Breast Cancer That Is Recurrent or Cannot Be Removed by Surgery

Breast

This phase Ib trial studies the side effects and best dose of pan-FGFR tyrosine kinase inhibitor JNJ-42756493 when given together with fulvestrant and palbociclib in treating patients with estrogen receptor positive, HER2 negative, and FGFR amplified stage IV breast cancer that has come back or cannot be removed by surgery. Drugs used in chemotherapy, such as fulvestrant, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Palbociclib and pan-FGFR tyrosine kinase inhibitor JNJ-42756493 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fulvestrant, palbociclib, and pan-FGFR tyrosine kinase inhibitor JNJ-42756493 may work better in treating patients with breast cancer.
Breast
I
Mayer, Ingrid
NCT03238196
VICCBRE16126

Weight Loss Interventions in Treating Overweight and Obese Women with a Higher Risk for Breast Cancer Recurrence

Breast

This randomized phase III trial studies weight loss interventions in treating overweight and obese women with a higher risk for breast cancer that comes back (recurrence). Many studies have shown that women who are overweight or obese when diagnosed with breast cancer appear to have a higher risk of cancer recurrence. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the program.
Breast
III
Rexer, Brent
NCT02750826
ECOGBREA011401

Pembrolizumab in Treating Patients with Triple-Negative Breast Cancer

Breast

This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Breast
III
Rexer, Brent
NCT02954874
ECOGBRES1418

Galunisertib and Paclitaxel in Treating Patients with Metastatic Androgen Receptor Negative or Triple Negative Breast Cancer

Breast

This phase I trial studies the side effects and best dose of galunisertib when given together with paclitaxel in treating patients with androgen receptor negative or triple negative breast cancer that has spread to other places in the body. Some tumors need growth factors, which are made by the body's white blood cells, to keep growing. Galunisertib may interfere with growth factors and help cause tumor cells to die. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving glunisertib together with paclitaxel may kill more tumor cells.
Breast
I
Abramson, Vandana
NCT02672475
VICCBRE1557

Platinum Based Chemotherapy or Capecitabine in Treating Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy

Breast

This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.
Breast
III
Mayer, Ingrid
NCT02445391
ECOGBREEA1131

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