Trials (Sacro Cuore - Don Calabria Hospital)
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NCTID: NCT01940497
Title: A Study of the Safety of Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Early and Locally Advanced Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Study Summary: This non-randomized, multicenter, open-label study will assess the safety and efficacy of subcutaneously administered trastuzumab in participants with early and locally advanced HER2-positive breast cancer in two sequential cohorts. First 120 participants will be treated with subcutaneous (SC) trastuzumab 600 milligrams (mg) vial (Cohort A) and the subsequent 120 participants will be treated with SC trastuzumab prefilled single use injection device (SID) (Cohort B). Participants from each cohort will receive neoadjuvant or adjuvant chemotherapy consisting of doxorubicin every 3 weeks (q3w) (1 cycle) for 4 cycles followed by paclitaxel weekly or docetaxel every 3 weeks (q3w) in combination with SC trastuzumab (600 mg) q3w for 4 cycles and a further 14 cycles of SC trastuzumab (600 mg) q3w alone. All participants will be followed up for 24 months after the last participant has received the last dose of study treatment, or earlier in case of withdrawal from the study, loss to follow-up or death. Sponsor: Hoffmann-La Roche Intervention: Doxorubicin Start Date: 2013-11-15 Last Updated: 2020-11-03 Number of Patients: 240 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03439215
Title: PF-06463922 for Crizotinib Pretreated ROS1 Positive Non-small-cell Lung Cancer Study Summary: This is a phase II study assessing response rate to PF-06463922 in patients with ROS1 translocation resistant to previous crizotinib therapy. Eligible patients will be treated with the study drug until disease progression, unacceptable toxicity or patient refusal. Disease assessment will be performed every 8 weeks according to RECIST criteria. Sponsor: Fondazione Ricerca Traslazionale Intervention: Lorlatinib Start Date: 2017-06-13 Last Updated: 2021-07-19 Number of Patients: 20 Recruitment Status: UNKNOWN Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT03144947
Title: Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Trastuzumab in HER2+ Breast Cancer Patients Study Summary: Phase II, Open Label, Randomized, Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Subcutaneous (SC) Trastuzumab in Patients with Operable or Locally Advanced /Inflammatory HER2-positive Breast Cancer (ImmunHER) Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica Intervention: Trastuzumab IV Start Date: 2016-11-29 Last Updated: 2020-10-14 Number of Patients: 65 Recruitment Status: UNKNOWN Condition: Cancer, Breast
NCTID: NCT03760003
Title: Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis Study Summary: Phase IIb study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis. Sponsor: Abivax S.A. Intervention: ABX464 25mg Start Date: 2019-09-23 Last Updated: 2021-08-02 Number of Patients: 254 Recruitment Status: COMPLETED Condition: Ulcerative Colitis
NCTID: NCT02633189
Title: Study Comparing Bevacizumab + Erlotinib vs Erlotinib Alone as First Line Treatment of Patients With EGFR Mutated Advanced Non Squamous Non Small Cell Lung Cancer Study Summary: The purpose of this study is to test whether the combination of bevacizumab and erlotinib can prolong progression free survival as compared with erlotinib alone as first-line treatment in patients with non small cell lung cancer (NSCLC) with activating mutation of EGFR. Sponsor: National Cancer Institute, Naples Intervention: Erlotinib Start Date: 2016-04 Last Updated: 2023-03-24 Number of Patients: 200 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-squamous Non-small Cell Lung Cancer
NCTID: NCT01379989
Title: INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer Study Summary: The objective of this multicentric, randomised, Phase III study is to demonstrate superiority, in terms of survival, of trabectedin and Pegylated Liposomal Doxorubicin (PLD) versus carboplatin and PLD in partially-platinum sensitive ovarian cancer patients. Sponsor: Mario Negri Institute for Pharmacological Research Intervention: Carboplatin Start Date: 2011-06 Last Updated: 2022-02-09 Number of Patients: 617 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT04884282
Title: Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED) Study Summary: This is a phase II, non-comparative, randomized study assessing combination of Tedopi with docetaxel or with nivolumab in NSCLC patients failing after first- line chemoimmunotherapy. In this non-comparative study, the standard arm (arm C) will serve as a calibration arm. All NSCLC patients candidate for second- line therapy are considered eligible for the study if they are HLA-A2+ and if they progressed after at least 4 cycles of previous first-line chemo-immunotherapy. After evaluation of all inclusion and exclusion criteria and after informed consent signature, all eligible patients will be treated with Tedopi plus docetaxel (arm A) or Tedopi plus nivolumab (arm B) or docetaxel as single agent (arm C- standard arm). Docetaxel therapy will be given until disease progression, unacceptable toxicity or patient refusal, and up to maximum 6 cycles. Tedopi or nivolumab will be given until disease progression, unacceptable toxicity or patient refusal. Sponsor: Fondazione Ricerca Traslazionale Intervention: Tedopi Start Date: 2021-10-12 Last Updated: 2023-09-18 Number of Patients: 105 Recruitment Status: RECRUITING Condition: Metastatic Non Small Cell Lung Cancer
NCTID: NCT01802749
Title: Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer Study Summary: Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab. Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined. This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone. Sponsor: National Cancer Institute, Naples Intervention: Bevacizumab Start Date: 2013-11 Last Updated: 2023-03-24 Number of Patients: 406 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Recurrent Ovarian Cancer
NCTID: NCT05132582
Title: A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer Study Summary: This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer. Sponsor: Seagen Inc. Intervention: Tucatinib Start Date: 2022-03-07 Last Updated: 2023-11-29 Number of Patients: 650 Recruitment Status: RECRUITING Condition: HER2 Positive Breast Cancer
NCTID: NCT04189445
Title: Futibatinib in Patients With Specific FGFR Aberrations Study Summary: The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma <math display="block">iCCA</math>); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements. Sponsor: Taiho Oncology, Inc. Intervention: Futibatinib Start Date: 2020-08-24 Last Updated: 2023-06-06 Number of Patients: 115 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced or Metastatic Solid Tumor
NCTID: NCT03713593
Title: Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002) Study Summary: The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants. The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: lenvatinib Start Date: 2018-12-31 Last Updated: 2023-07-24 Number of Patients: 794 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Hepatocellular
NCTID: NCT04075305
Title: The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study Study Summary: The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients’ survival, local, and regional tumor control and quality of life. Sponsor: UMC Utrecht Intervention: Radiation therapy Start Date: 2019-02-01 Last Updated: 2023-09-28 Number of Patients: 8000 Recruitment Status: RECRUITING Condition: Oncology
NCTID: NCT04546009
Title: A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer) Study Summary: This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer. Sponsor: Hoffmann-La Roche Intervention: Giredestrant Start Date: 2020-10-09 Last Updated: 2023-11-18 Number of Patients: 992 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
NCTID: NCT03045406
Title: Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer Study Summary: Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study Sponsor: Fadoi Foundation, Italy Intervention: Apixaban Start Date: 2017-04-13 Last Updated: 2019-11-14 Number of Patients: 1168 Recruitment Status: UNKNOWN Condition: Venous Thromboembolism
NCTID: NCT05794906
Title: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies Study Summary: Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen <math display="block">PSMA</math> positron emission tomography <math display="block">PET</math>) /computed tomography <math display="block">CT</math>) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a “tracer” that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: * take blood and urine samples. * measure PSA and testosterone levels in the blood samples * do physical examinations * check the participants’ overall health * examine heart health using electrocardiogram (ECG) * check vital signs * check cancer status using PSMA PET/CT scans, CT, MRI and bone scans * take tumor samples (if required) * ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants’ health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first. Sponsor: Bayer Intervention: Darolutamide (BAY1841788, Nubeqa) Start Date: 2023-04-03 Last Updated: 2023-11-28 Number of Patients: 750 Recruitment Status: RECRUITING Condition: Biochemically Recurrent Prostate Cancer
NCTID: NCT00849667
Title: Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse Study Summary: This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer. Sponsor: Morphotek Intervention: Farletuzumab Start Date: 2009-04-16 Last Updated: 2022-12-30 Number of Patients: 1100 Recruitment Status: TERMINATED Condition: Ovarian Cancer
NCTID: NCT02499614
Title: Crizotinib in Pretreated Metastatic Non-small-cell Lung Cancer With MET Amplification or ROS1 Translocation (METROS) Study Summary: Phase II, two arms, parallel, non comparative study with crizotinib in patients with ROS 1 translocation or MET amplification or MET exon 14 mutation Sponsor: Fondazione Ricerca Traslazionale Intervention: Crizotinib Start Date: 2014-12 Last Updated: 2017-10-25 Number of Patients: 80 Recruitment Status: UNKNOWN Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT03823625
Title: An Open-label, Randomized, Parallel, Non Comparative, Phase II Trial of Nivolumab Plus Ipilimumab Versus Platinum-based Chemotherapy Plus Nivolumab in Chemonaive Metastatic or Recurrent Squamous-Cell Lung Cancer (SqLC) Study Summary: Non-small-cell Lung Cancer (NSCLC) remains the leading cause of cancer death in Western Countries. Approximately 85% of lung cancers are of the non-small-cell type (NSCLC), with 25-30% of NSCLC being squamous histology type. Unlike nonsquamous NSCLC, squamous NSCLC rarely harbors epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations for which there are directed therapies, and until the recent approval of immunotherapies for pretreated squamous NSCLC, a limited number of traditional cytotoxic chemotherapy drugs have been FDA-approved for use in the treatment of advanced and metastatic squamous NSCLC. A platinum-based combination chemotherapy regimen has been the standard first-line treatment for all NSCLC. Carboplatin is frequently substituted for cisplatin for patients who have poor renal function or who experience toxicities from cisplatin (most notably, nausea and vomiting). Taxanes, especially paclitaxel, or vinorelbine or gemcitabine, commonly complete the standard two-drug backbone of platinum-based chemotherapy for the first-line treatment of NSCLC, with platin-gemcitabine as the most commonly used regimen in Europe in patients with squamous-histology. A recent press release announced that pembrolizumab plus chemotherapy produced higher response rate when compared to chemotherapy alone in patients with squamous-cell lung cancer. Nevertheless, no data on Progression-Free Survival (PFS) and Overall Survival (OS) are available. Therefore, considering the lack of data in patients with squamous histology and the lack of information about efficacy of combinations of immune-checkpoints inhibitors versus immune-checkpoint inhibitor plus chemotherapy, there is a strong rationale for conducting a study assessing efficacy of such strategies in patients with advanced, metastatic squamous-cell lung cancer. Sponsor: Fondazione Ricerca Traslazionale Intervention: Nivolumab plus Ipilimumab Start Date: 2017-09-13 Last Updated: 2020-03-25 Number of Patients: 112 Recruitment Status: UNKNOWN Condition: Squamous-Cell Lung Cancer
NCTID: NCT03595592
Title: Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer Study Summary: n the present study the neoadjuvant approach with the anti-HER2 trastuzumab and pertuzumab combined with carboplatin and paclitaxel will be used to compare the Event-Free Survival (EFS) in regimens with and without atezolizumab. Following the neoadjuvant part of the study, after surgery all patients will continue to receive trastuzumab and pertuzumab to complete one year of anti-HER2 therapy. Similarly, patients allocated to receive atezolizumab will continue atezolizumab to complete one year In addition, several IHC and molecular assays will be performed before and during the period of chemotherapy administration and at surgery with the goal of defining a marker of efficacy to be later validated in a larger adjuvant setting. Sponsor: Fondazione Michelangelo Intervention: Trastuzumab Start Date: 2018-09-07 Last Updated: 2023-02-15 Number of Patients: 650 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Invasive Breast Cancer
NCTID: NCT03523585
Title: DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] Study Summary: This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: * cannot be removed by an operation * has spread to other parts of the body Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan Start Date: 2018-08-01 Last Updated: 2023-06-26 Number of Patients: 608 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT01339260
Title: An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting Study Summary: NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. The objective of the study is to demonstrate that netupitant and palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles of chemotherapy. Sponsor: Helsinn Healthcare SA Intervention: Netupitant and Palonosetron Start Date: 2011-04 Last Updated: 2014-11-26 Number of Patients: 1455 Recruitment Status: COMPLETED Condition: Chemotherapy-Induced Nausea and Vomiting
NCTID: NCT02163694
Title: A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer Study Summary: The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic or locally advanced unresectable breast cancer. The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR) through the end of Week 24, objective response rate (ORR) and PFS on subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P versus placebo in combination with C/P. Sponsor: AbbVie Intervention: Veliparib Placebo Start Date: 2014-07-17 Last Updated: 2023-02-16 Number of Patients: 509 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT03734029
Title: Trastuzumab Deruxtecan (DS-8201a) Versus Investigator’s Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] Study Summary: This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants’ cancer: * Cannot be removed by an operation * Has spread to other parts of the body Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan (DS-8201a) Start Date: 2018-12-27 Last Updated: 2023-06-15 Number of Patients: 557 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT04961996
Title: A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician’s Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) Study Summary: This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician’s choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population. Sponsor: Hoffmann-La Roche Intervention: Giredestrant Start Date: 2021-08-27 Last Updated: 2023-11-18 Number of Patients: 4200 Recruitment Status: RECRUITING Condition: Early Breast Cancer
NCTID: NCT02402712
Title: Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer Study Summary: This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients are to receive study medication until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end, whichever occurs first. The anticipated time on study treatment is approximately 24 months. The target sample size is 400. Sponsor: Hoffmann-La Roche Intervention: Docetaxel Start Date: 2015-05-06 Last Updated: 2019-09-06 Number of Patients: 418 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01808573
Title: A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting Study Summary: This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting. Sponsor: Puma Biotechnology, Inc. Intervention: neratinib Start Date: 2013-03-29 Last Updated: 2021-06-11 Number of Patients: 621 Recruitment Status: COMPLETED Condition: HER2+ Metastatic Breast Cancer (MBC)
NCTID: NCT02394496
Title: Overcoming Endocrine Resistance in Metastatic Breast Cancer Study Summary: Based on these results it can be envisioned that the majority of endocrine-responsive post-menopausal breast cancer patients will be treated with an AI as adjuvant therapy (front-line, switching or extending) and/or as first-line management of metastatic breast cancer. Sponsor: Consorzio Oncotech Intervention: Fulvestrant Start Date: 2007-11 Last Updated: 2016-06-15 Number of Patients: 396 Recruitment Status: UNKNOWN Condition: Metastatic Breast Cancer
NCTID: NCT02926196
Title: Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab Study Summary: Phase III randomized trial of the anti-PD-L1 antibody avelumab as adjuvant or post-neoadjuvant treatment for high-risk triple negative breast cancer patients. The overall protocol-defined patient population will include the following two strata of patients: * Stratum A - Patients who have completed treatment with curative intent including surgery of the primary tumor followed by adjuvant chemotherapy . * Stratum B - Patients who have completed treatment with curative intent including neoadjuvant chemotherapy followed by surgery of the primary tumor and (if indicated) further adjuvant chemotherapy. Sponsor: Istituto Oncologico Veneto IRCCS Intervention: MSB0010718C Start Date: 2016-06-17 Last Updated: 2023-10-31 Number of Patients: 474 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Triple Negative Breast Neoplasms
NCTID: NCT03569241
Title: PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases Study Summary: A proportion of prostate cancer (PCa) patients develop relapse following curative local treatment. Regional nodal recurrence is an emerging clinical situation since the introduction of new molecular imaging methods in the restaging of recurrent prostate cancer. More specifically, a subgroup of these patients is being diagnosed with a recurrence confined to the regional lymph nodes and limited in number (oligorecurrence) using choline or PSMA PET-CT. As there are no specific treatment recommendations for these type of patients, different treatment approaches are currently used, mostly focusing on local ablative treatments using radiotherapy or surgery. These treatments are coined metastasisdirected therapy (MDT). MDT in combination with or without temporary ADT could delay the subsequent risk of progression, and even cure limited regional nodal recurrences. Consequently, lifelong palliative ADT, with its toxicity and excess in non-cancer mortality might be postponed. The proposed trial randomizes patients with oligorecurrent nodal prostate cancer following primary PCa treatment to either metastasis-directed therapy (MDT) (salvage lymph node dissection, sLND or stereotactic body radiotherapy, SBRT) or MDT plus whole pelvis radiotherapy (WPRT: 45 Gy in 25 fractions). Sponsor: University Ghent Intervention: whole pelvic radiotherapy Start Date: 2018-04-27 Last Updated: 2023-06-28 Number of Patients: 196 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer
NCTID: NCT03137576
Title: Erector Spinae Plane Block Versus Paravertebral Block During Non-intubated Thoracoscopic Lung Resections. Study Summary: A randomized prospective trial to test the non-inferiority of Erector Spinae Plane Block (ESPB) in comparison with paravertebral block during non-intubated thoracoscopic lung resection Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar Intervention: Paravertebral Block (PVB) Start Date: 2019-02-22 Last Updated: 2022-05-11 Number of Patients: 7 Recruitment Status: TERMINATED Condition: Lung Neoplasms
NCTID: NCT04905069
Title: Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy Study Summary: To demonstrate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in subjects undergoing Stereotactic Body Radiotherapy (SBRT) to treat prostate cancer. Sponsor: Boston Scientific Corporation Intervention: SpaceOAR Vue System Start Date: 2021-12-21 Last Updated: 2023-11-21 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Prostate Cancer
