Manistique

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

Researchers are evaluating a text-based program designed to help rural cancer survivors who smoke to quit smoking. This phase III trial compares an eight-week scheduled gradual reduction SGR intervention delivered via personalized text messages combined with the National Cancer Institutes Smokefree.TXT service to a control group receiving a smoking cessation booklet. The study aims to assess how effective these approaches are in achieving biochemically validated smoking cessation six months after quitting, as well as their impact on quality of life. Participants are randomly assigned to one of two groups. The first group follows a personalized eight-week gradual reduction schedule, supported by cessation messages sent by text for 12 weeks. The second group receives the NCI Clearing the Air booklet to assist in planning gradual smoking cessation. After completing the interventions, participants are followed for a total of six months post-quit date to evaluate outcomes. During the study, participants will provide urine samples and complete questionnaires to measure smoking status and quality of life at baseline, 30 days, and six months after quitting. The research team uses biochemical validation to confirm smoking cessation. Participants must have texting capability on a cell phone or smartphone and be able to read and speak English. The total participation includes the intervention period plus follow-up to monitor smoking cessation and quality of life changes.

Researchers are evaluating whether using the PAGODA algorithm to guide chemotherapy dosing can reduce unplanned delays during chemotherapy for cancers in the gastrointestinal system. This study compares the PAGODA algorithm against usual care in patients receiving FOLFOX chemotherapy. The trial aims to assess the effect on treatment scheduling, healthcare contact days, severity of neutropenia, and chemotherapy dose intensity. Participants are randomly assigned to one of two groups. One group receives chemotherapy dose adjustments and delays based on the PAGODA algorithm followed by clinician decision during cycles 2 to 7 of standard FOLFOX chemotherapy. The other group receives dose modifications and delays at the treating clinicians discretion during the same chemotherapy cycles. Treatments include intravenous oxaliplatin, folinic acid, and fluorouracil. During the study, participants will be monitored for unplanned chemotherapy delays from cycle 2 through cycle 7, with each cycle lasting 14 days. Researchers will also track health care contact days over 120 days, moderate-to-severe neutropenia, and relative dose intensity of key chemotherapy drugs. The study involves randomized assignment and careful evaluation of treatment timing and dosing effects in patients receiving chemotherapy for gastrointestinal cancers.