S2010, A RANDOMIZED PHASE III TRIAL COMPARING ACTIVE SYMPTOM MONITORING PLUS PATIENT EDUCATION VERSUS PATIENT EDUCATION ALONE TO IMPROVE PERSISTENCE WITH ENDOCRINE THERAPY IN YOUNG WOMEN WITH STAGE I-III BREAST CANCER (ASPEN) (CTMS# 23-0014)
This phase III trial compares the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines. The patient education tool contains interactive weblinks which provide patients with education material about breast cancer and side effects of therapy. Symptom monitoring is a weblink via email or text message with questions asking about symptoms. Hormone therapy for breast cancer can cause side effects, and may cause some women to stop treatment early. Asking about symptoms more often may help women keep taking hormone therapy medicines
Shortening Adjuvant PHoton IRradiation (SAPHIRe): A Randomized Trial of Hypofractionated Versus Conventionally Fractionated Regional Nodal Irradiation for Invasive Breast Cancer (CTMS# 23-0020)
To compare how often cancer recurs (comes back) after 3 weeks of radiation compared to 5 weeks of radiation in patients who receive radiation therapy delivered to the lymph nodes near the breast. The side effects that can develop during or after radiation treatment, including how often arm swelling (edema) happens, will also be studied
S2015 Melanoma Margins Trial (MelMarT): A Phase III, Multi-Centre, Multi-National Randomised Control Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma (CTMS# 23-0072)
The primary objective of the trial is to assess whether there is no difference in disease-free survival for patients treated with a 1cm excision margin when compared to a 2cm margin for stage II primary melanomas (AJCC 8th edition; pT2b-pT4b).
A Phase II multicenter, open-label, single-arm dose escalation study of Asciminib monotherapy in 2nd and 1st Line Chronic Phase – Chronic Myelogenous Leukemia (ASC2ESCALATE) (CTMS# 23-0101)
This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP-binding site TKI with discontinuation due to treatment failure, warning, or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort.
S1400, "Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer (Screening Step) Lung-MAP Sub-Study” (CTRC #14-0036)
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.
Aging mammary stem cells and breast cancer prevention
To examine whether rapamycin can reduce malignant markers and aberrant mammary stem/progenitor cells (MaSCs) number in surgical specimens