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Everything in development, the open problems and what is being done about them, the roadmaps, and what changed on this record.
What is in development for HR-positive / HER2-negative breast cancer, drawn from the whole corpus: 281 items. Drugs are grouped by the most advanced trial phase they have reached anywhere; approved treatments sit under standard of care. Technologies are the methods being tested for this cancer, trials are the studies recorded here, and ideas are proposals not yet in a trial.
Late recurrence (up to 20+ years) with no predictive test.
Background: Circulating tumour DNA (ctDNA), Late recurrence, Tumour dormancy. Also on OnCo: Treatment journeys · Survivorship planner.
CDK4/6 resistance mechanisms and sequencing.
Background: ADC sequencing, Circulating tumour DNA (ctDNA), Endocrine resistance, ESR1 mutation. Also on OnCo: Resistance atlas · Lines of therapy.
Endocrine therapy adherence and toxicity.
Also on OnCo: Side effects by symptom · Immune-related side effects · Toxicity compare · Survivorship planner.
Late recurrence: half of relapses occur after year 5 and no test reliably identifies who needs extended or intensified therapy.
Background: Circulating tumour DNA (ctDNA), Late recurrence, Tumour dormancy. Also on OnCo: Treatment journeys · Survivorship planner.
Adherence: a third of women stop adjuvant endocrine therapy early because of arthralgia, hot flushes, and sexual side effects.
Also on OnCo: Side effects by symptom · Immune-related side effects · Toxicity compare · Survivorship planner.
Sequencing after CDK4/6: no head-to-head trials among oral SERDs, PI3K/AKT agents, everolimus combinations, and ADCs.
Does acting on ctDNA improve survival? SERENA-6 improved PFS; OS and patient-reported outcomes are unresolved, as the ODAC vote showed.
Palbociclib versus ribociclib versus abemaciclib: different survival results without a randomised comparison.
HER2-low scoring reproducibility at IHC 0/1+ determines T-DXd eligibility for millions of patients.
Invasive lobular carcinoma is under-represented in trials despite being 10-15% of cases.
Premenopausal women: whether chemotherapy's benefit in RxPONDER is simply ovarian suppression (NRG-BR009 / OFSET will answer).
Dated changes read from the records linked to this cancer: approvals, regulatory steps, reported trials, guideline versions and milestones. Newest first; no date is inferred.
On EdgeAll 104 changes by month →When this page itself was last checked or edited.
FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer
FDA clearance: first digital-pathology-based risk stratification tool for early HR+/HER2- breast cancer
persevERA primary endpoint not met
NDA accepted (evERA, ESR1-mutant)
Positive topline phase 2 FOURLIGHT-1