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A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

Scottsdale/Phoenix, AZ, Rochester, MN, Jacksonville, FL

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A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This is a two arm Phase III trial in first and second-line HER2 negative patients with locally recurrent or metastatic breast cancer. The primary endpoint is overall survival (OS), and the objective is to test for the superiority of eribulin mesylate over standard weekly paclitaxel. Patients will be randomized between the experimental and control arm with equal allocation (1:1) within strata defined by prior adjuvant taxanes, hormone receptor status, and line of therapy. Subjects will continue protocol directed therapy until documentation of disease progression, development of unacceptable toxicity, or withdrawal of consent. Those who discontinue study treatment without radiological progression will be followed with repeat imaging studies every 12 weeks. All subjects will be followed until death, withdrawal of consent, or study termination.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information
Jacksonville, Fla.	Closed for enrollment
Scottsdale/Phoenix, Ariz.	Closed for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 13-002454
- Jacksonville, Florida: 13-002454
- Scottsdale/Phoenix, Arizona: 13-002454
NCT ID:
NCT02037529
Sponsor Protocol Number:
RU011201I

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz.	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Contact us for the latest status	View complete study & contact information

A Study to Evaluate Niraparib and TSR-042 in Patients with Germline or Somatic BRCA1/2 and PALB2-related Pancreatic Cancer

Rochester, MN, Jacksonville, FL, Scottsdale/Phoenix, AZ

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A Study to Evaluate Niraparib and TSR-042 in Patients with Germline or Somatic BRCA1/2 and PALB2-related Pancreatic Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

In our own data sequencing 3,000 patients with pancreatic cancer, approximately 3% of pancreatic cancer patients harbor germline mutations in DNA repair genes such as BRCA1/2 and PALB2, and are therefore potential candidates for PARP-inhibitor therapy. In addition, somatic mutations in Homologous Recombination Repair (HRR) genes can confer sensitivity as well, and have been reported to double the number of patients potentially eligible for such therapy. The Keynote-162 study of niraparib and pembrolizumab has validated this approach, with early reports of impressive efficacy. Although unselected trials in pancreatic cancer with immunotherapy alone have yet to be successful, we hypothesize that induced genetic variation with PARP inhibition disrupting the tumor microenvironment and increasing neoepitope expression can sensitize tumors to immune checkpoint inhibition. We have developed preliminary data with RNAseq suggesting that potent PARP inhibition is associated with gain of novel mutations in pancreas cell lines, even compared to cisplatin alone, or irinotecan alone. We propose that a combination of PARP inhibition and anti-PD1 therapy has valuable therapeutic potential in pancreatic cancer. HRR deficient pancreatic cancer has largely been defined to date based on mutations in well-established genes such as BRCA1/2 and PALB2. However, more DNA repair associated genes are becoming associated with risk for pancreatic cancer and may well impact tumor phenotype. The goal would be to evaluate the combination of niraparib and TSR-042 in patients with germline or somatic mutations in BRCA1/2 or PALB2.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information
Jacksonville, Fla.	Closed for enrollment
Scottsdale/Phoenix, Ariz.	Closed for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 18-003525
- Jacksonville, Florida: 18-003525
- Scottsdale/Phoenix, Arizona: 18-003525
NCT ID:
NCT04493060
Sponsor Protocol Number:
MC1841

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Search Results 551-560 of 2766 for cancer

A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)

Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer

Study Of Relacorilant In Combination With Pembrolizumab For Patients With Adrenocortical Carcinoma With Excess Glucocorticoid Production

A Study to Test Nivolumab with Usual Chemotherapy Treatment or Usual Chemotherapy Treatment Alone to Treat Recurrent or Metastatic Nasopharyngeal Cancer

A Study To Assess The Effectiveness Of Osimertinib Plus Savolitinib In Patients With Locally Advanced Or Metastatic Non Small Cell Lung Cancer Who Have Progressed Following Osimertinib Treatment (SAVANNAH Study) Following Prior Osimertinib

Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer

Study of Rituximab and LMP-Specific T-Cells in Treating Pediatric Solid Organ Recipients With EBV-Positive, CD20-Positive Post-Transplant Lymphoproliferative Disorder

Pembrolizumab Plus Epacadostat Alone or With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-02/ECHO-306)

A Study to Evaluate Niraparib and TSR-042 in Patients with Germline or Somatic BRCA1/2 and PALB2-related Pancreatic Cancer

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