Genolier

Researchers are evaluating whether combining pelabresib with ruxolitinib improves clinical outcomes compared to ruxolitinib alone in adults with primary myelofibrosis PMF, post-polycythemia vera myelofibrosis PPV-MF, or post-essential thrombocythemia myelofibrosis PET-MF who have not previously been treated with Janus kinase JAK inhibitors. This Phase 3 trial focuses on participants with intermediate or high-risk disease and assesses symptom burden and spleen size among other clinical measures. Participants begin with a screening period lasting up to 28 days to confirm eligibility and complete baseline tests. During the treatment phase, they are randomly assigned to receive either pelabresib orally once daily for 14 days of each 21-day cycle plus continuous ruxolitinib twice daily, or a matching placebo plus ruxolitinib. Treatment continues until unacceptable side effects, disease progression, or withdrawal. After treatment, a 30-day safety follow-up monitors for late side effects. Participants who have not experienced disease progression enter an efficacy follow-up with visits every 12 weeks for ongoing assessments including spleen imaging, lab tests, and bone marrow biopsies. Those with progression or new therapy start survival follow-up visits every 12 weeks, which may be remote, to monitor overall survival and disease status. The study includes comprehensive symptom scoring and spleen response evaluations over approximately three years.

Researchers are investigating whether tailored axillary surgery TAS combined with axillary radiotherapy ART is better than the current standard treatment, axillary lymph node dissection ALND, for patients with clinically node-positive breast cancer undergoing upfront surgery. The study aims to see if TAS plus ART improves arm-related quality of life and reduces the occurrence of lymphedema two years after treatment. This question arises because ALND, although standard, can cause significant side effects, and TAS selectively targets affected lymph nodes with potentially less harm. Participants will be randomly assigned to one of two groups one receiving ALND, which involves removing lymphatic tissue within the axilla, and the other receiving TAS with ART, where surgery removes sentinel and suspicious lymph nodes followed by targeted axillary radiotherapy. All participants will also receive breast or chest wall irradiation after breast-conserving surgery. The study compares these approaches to assess their impact on arm health and quality of life. During the trial, participants will be followed for at least two years to assess changes in arm-related quality of life and monitor for lymphedema. Researchers will collect quality of life questionnaires and clinical evaluations over this period. The study is sponsored by University Hospital Basel and aims to complete primary outcome assessments by the end of 2029, with overall study completion planned for 2037.

Researchers are studying the use of vacuum-assisted biopsy VAB to better detect remaining breast cancer tissue after neoadjuvant chemotherapy NAC, which is a common initial treatment for breast cancer. NAC can lead to complete disappearance of the tumor in aggressive cancer types, but current imaging methods cannot reliably predict if any cancer remains. This study aims to compare the accuracy of tissue samples taken by VAB before surgery to the standard surgical tissue samples to see if VAB can serve as a less invasive way to check for residual cancer. Participants will undergo ultrasound- or mammography-guided VAB to sample tissue from the former tumor site after NAC and before standard breast surgery. The trial focuses on patients with certain breast cancer types who show a complete or near-complete response on imaging after chemotherapy. After the biopsy, participants will have breast conserving surgery or mastectomy, and both biopsy and surgical samples will be examined to evaluate the presence of residual cancer. During the study, patients will be monitored closely with imaging before VAB and surgery, and the tissue samples will be analyzed for residual disease. Researchers will measure how accurately VAB detects residual cancer compared to surgery by assessing sensitivity, specificity, and predictive values. Safety will be monitored from the biopsy until two weeks after surgery. The total time from registration to outcome measurement is up to six weeks.

Researchers are evaluating the use of doxycycline, an older and affordable antibiotic, to target cancer stem cells in patients with early-stage estrogen receptor positive ER and human epidermal growth factor receptor 2-negative HER2- breast cancer. These cancer stem cells are believed to cause treatment resistance and cancer recurrence, and the study aims to see if doxycycline can improve patients response to standard neoadjuvant chemotherapy. This is a phase II, open-label clinical trial focusing on this specific breast cancer subtype with low rates of complete tumor response to current treatments. Participants will receive neoadjuvant chemotherapy consisting of four cycles of epirubicin and cyclophosphamide every three weeks, followed by 12 weekly doses of paclitaxel. Alongside chemotherapy, doxycycline will be given orally at a dose of 200 mg per day from day 5 to day 18 of each chemotherapy cycle. The study will analyze tumor samples before and after treatment to assess changes in cancer stem cell markers and measure pathological response to treatment. During the trial, participants will undergo tumor biopsies and surgery after completing chemotherapy. Researchers will assess the presence of ALDH1, a marker of cancer stem cells, and evaluate pathological complete response by checking for any remaining invasive cancer in the breast and lymph nodes. Additional measures include tumor shrinkage on imaging, patient adherence to doxycycline, and patient-reported treatment burden. The study monitors safety and treatment effects up to 30 days after the last treatment dose, with a total participation period spanning from registration through surgery and follow-up assessments.