UNICANCER | MedPath

Natera Launches HEROES Trial to Explore Treatment De-escalation in HER2+ Metastatic Breast Cancer

2 months ago

• Natera has enrolled the first patients in the HEROES phase II clinical trial, investigating the potential to safely discontinue anti-HER2 therapy in metastatic breast cancer patients with no detectable circulating tumor DNA. • The trial will use Natera's Signatera test to identify patients who may safely stop maintenance therapy, potentially freeing them from lifelong treatment regimens that can be costly and cause adverse effects. • Approximately 170 patients across 35 French sites will participate in the study, which could fundamentally change treatment approaches for the 15-20% of breast cancer patients with HER2-positive tumors.

EU Launches €9.5M Path4Young Initiative to Revolutionize Breast Cancer Care for Young Women

4 months ago

A groundbreaking €9.5 million European project, Path4Young, aims to transform breast cancer treatment for young women by personalizing care and reducing unnecessary chemotherapy. Led by Dr Inès Vaz Luis and coordinated by Unicancer, this international initiative will conduct the OPTIMA-YOUNG trial across 300 centers worldwide, targeting improved outcomes and quality of life for premenopausal breast cancer patients.

SAFIR-ABC10 Trial: Precision Medicine Approach Aims to Extend Survival in Bile Duct Cancer

4 months ago

• The SAFIR-ABC10 trial is a precision medicine study offering tailored therapies based on the genetic profile of bile duct tumors. • The trial includes patients with intrahepatic, perihilar, or distal cholangiocarcinoma, as well as gallbladder cancer. • The study aims to recruit 800 participants globally, offering one or more of seven anti-cancer therapies matched to tumor targets. • Early results show promise, with some patients experiencing remission or conversion to operable status, potentially improving survival rates.

Greenwich LifeSciences Expands Phase III Breast Cancer Trial Globally, Adds New Sites and Expertise

4 months ago

• Greenwich LifeSciences broadens its Phase III FLAMINGO-01 trial for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrence, by adding new clinical sites in the U.S. and Europe. • The trial expands into France through a partnership with Unicancer, activating 19 sites, and collaborates with GBG in Germany, adding approximately 38 sites to the study. • Harvard and Johns Hopkins join the trial in the U.S., with principal investigators Dr. Laura Spring and Dr. Cesar Santa-Maria joining the Steering Committee. • EMA approves the addition of 11 sites in Spain, Germany, and Poland, potentially activating 110-115 sites in Europe, with plans to expand to Ireland, Romania, and other countries.

Intensity Therapeutics' Sarcoma Trial INT230-6 Authorized to Continue by DMC

4 months ago

• Intensity Therapeutics' Phase 3 INVINCIBLE-3 study of INT230-6 in soft tissue sarcoma is authorized to continue without modifications after a Data Monitoring Committee review. • The global, randomized trial compares intratumoral INT230-6 to standard-of-care chemotherapy in patients with leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma. • INT230-6 showed a median overall survival of 21.3 months in Phase 1/2 data, compared to 6.7 months in a synthetic control, alongside increased T-cell activation and a favorable safety profile. • The INVINCIBLE-3 study is actively recruiting across the US, Canada, and Europe, aiming to enroll 333 patients to evaluate overall survival and safety.

EDAP TMS Treats First Patient with HIFU in Pancreatic Cancer Trial

4 months ago

• EDAP TMS SA has initiated a Phase I/II trial (PULS) using High Intensity Focused Ultrasound (HIFU) for pancreatic tumor treatment. • The first patient with locally advanced pancreatic cancer was treated successfully in the PULS trial, showing tolerance to the HIFU intervention. • The PULS trial aims to evaluate both the tolerance and preliminary efficacy of intraoperative HIFU for unresectable pancreatic tumors. • This milestone reflects EDAP's commitment to innovative therapies for areas of significant unmet medical need, like pancreatic cancer.

Short-Term ADT Plus High-Dose Radiotherapy Improves Outcomes in Localized Prostate Cancer

8 months ago

• A phase 3 trial (GETUG 14) reveals that combining short-term androgen deprivation therapy (ADT) with high-dose radiotherapy improves disease-free survival in localized prostate cancer patients. • The addition of ADT significantly reduces the risk of biochemical failure but does not significantly impact metastasis failure or overall survival. • Patients with intermediate-risk prostate cancer showed a notable improvement in 5-year disease-free survival with the combined therapy compared to radiotherapy alone. • The combination therapy did not increase gastrointestinal or genitourinary toxicities, but a higher rate of early erectile dysfunction was observed with ADT.

Hypofractionated Radiotherapy Shows Non-Inferior Lymphedema Risk in Early Breast Cancer

8 months ago

• A phase 3 trial (HypoG-01) demonstrated that moderately hypofractionated locoregional radiation therapy is non-inferior to standard normofractionated radiation therapy for early breast cancer patients. • The 5-year cumulative incidence of arm lymphedema was comparable between the hypofractionated (33.3%) and normofractionated (32.8%) radiotherapy arms. • Hypofractionated radiotherapy did not show detrimental effects on survival outcomes, local recurrence-free survival, or distant disease-free survival. • The findings suggest a shift towards a 3-week hypofractionated regimen, even for nodal radiotherapy, potentially reducing treatment burden and healthcare costs.

Hypofractionated Radiotherapy Shows Equivalence to Standard for Locoregional Breast Cancer

8 months ago

• The HypoG-01 trial demonstrates that a 3-week hypofractionated radiotherapy regimen is equivalent to a 5-week normofractionated regimen for locoregional breast cancer. • The study included 1,265 patients and found no significant difference in lymphoedema onset, locoregional relapse-free survival, or overall survival between the two regimens. • The 3-week hypofractionated course is now a standard of care for women with node-invasive breast cancer, offering convenience and reduced burden. • This academic study highlights France's capability to conduct impactful clinical trials, providing direct benefits for patients and healthcare systems.

Greenwich LifeSciences' Flamingo-01 Trial Expands into Europe and Broadens Patient Enrollment

a year ago

• Greenwich LifeSciences' Flamingo-01 Phase III trial, evaluating GLSI-100 for breast cancer recurrence prevention, has been approved for expansion into Europe, including Spain, France, Germany, Italy, and Poland. • The Flamingo-01 trial will activate 105 sites in Europe, with site initiation visits starting as early as March 4, 2024, aiming to enroll more patients and accelerate the study. • The trial's steering committee has agreed to expand the third arm of the study to enroll up to 250 patients with non-HLA-A*02 types, potentially broadening the patient population who could benefit from GLSI-100. • Greenwich LifeSciences is preparing for a BLA filing in the US, including commercial manufacturing data and study reports from prior clinical trials, marking progress toward potential commercialization of GLSI-100.