Clinical Trials for Breast Cancer

A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable,or Metastatic Triple-negative Breast Cancer (TNBC)or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with untreated, locally advanced/inoperable or metastatic TNBC (PD‑L1–ineligible or contraindicated for anti–PD-(L)1) or ER-low, HER2‑negative breast cancer ineligible for endocrine therapy, with measurable disease, are randomized to izalontamab brengitecan (BMS‑986507)—a bispecific EGFR/HER3-targeted antibody‑drug conjugate delivering a topoisomerase I inhibitor—versus physician’s choice of paclitaxel, nab‑paclitaxel, capecitabine, or carboplatin/gemcitabine. Key efficacy is assessed by blinded central review, with PFS primary and OS/ORR secondary.

ClinicalTrials.gov ID: NCT06926868

Phase 1 Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy (CTMS# 24-0096)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with HR-positive, HER2-negative metastatic breast cancer who have radiographic progression on a CDK4/6 inhibitor plus endocrine therapy (ribociclib or abemaciclib with an AI or fulvestrant) continue their current regimen with the addition of avasopasem, a small-molecule superoxide dismutase mimetic that modulates reactive oxygen species. Includes patients with treated/stable brain metastases; excludes current palbociclib and tamoxifen users and those requiring strong CYP3A4 modulators.

ClinicalTrials.gov ID: NCT07137871

A Phase 1/2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32367 in Patients With HER2-Positive Locally Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with HER2-positive locally advanced/metastatic solid tumors receive single-agent YH32367 (nesfrotamig/ABL105), a HER2×4‑1BB bispecific antibody that blocks HER2 signaling and provides localized 4‑1BB costimulation to T/NK cells; dose expansion focuses on previously treated HER2+ biliary tract cancer and other non–breast/gastric/GEJ HER2+ solid tumors after standard options. Key exclusions include active/unstable CNS disease, significant cardiac disease, ILD/pneumonitis, autoimmune disease requiring immunosuppression, and active viral hepatitis/HIV.

ClinicalTrials.gov ID: NCT05523947

Prevention of Datopotamab Deruxtecan (TROP-2 Directed ADC) Associated Stomatitis in Patients With HER2-negative Metastatic Breast Cancer or Non-small Cell Lung Cancer Using Dexamethasone Mouthwash: a Single-arm, Phase 2 Trial (TROPION- DM, 2023-ESR-000087)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with advanced/metastatic HER2-negative breast cancer (TNBC or HR+/HER2− post-CDK4/6 and chemo/ADC) or previously treated non-squamous NSCLC receive datopotamab deruxtecan (TROP2-directed ADC delivering a topoisomerase I inhibitor) plus prophylactic dexamethasone mouthwash. The study assesses whether short-course steroid mouthwash during the first three cycles reduces Dato-DXd–associated stomatitis while patients continue Dato-DXd q3w.

ClinicalTrials.gov ID: NCT06974604

An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline/TESARO-Sponsored Niraparib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Niraparib

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Single-arm extension providing continued niraparib to adults who completed a prior GSK/TESARO niraparib study and are still benefiting, with controlled toxicities and ongoing dosing from the parent protocol. Niraparib is an oral PARP-1/2 inhibitor exploiting synthetic lethality (e.g., HRD/BRCA-mutated tumors); treatment continues until progression/toxicity with focus on long-term safety monitoring.

ClinicalTrials.gov ID: NCT04641247

Randomized Phase II Study of Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor (Palbociclib, Abemaciclib, or Ribociclib) in Patients With ER+/HER2- Advanced or Metastatic Breast Cancer With Prior Exposure to a CKD4/6 Inhibitor

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with ER+/HER2− advanced or metastatic breast cancer harboring an ESR1 mutation, ECOG 0–1, previously treated with a CDK4/6 inhibitor and at least two prior endocrine therapies, are randomized to elacestrant (oral SERD) alone versus elacestrant plus a CDK4/6 inhibitor (palbociclib, abemaciclib, or ribociclib). Aims to test whether adding CDK4/6 blockade to elacestrant improves PFS in this post–CDK4/6–exposed, endocrine-resistant population.

ClinicalTrials.gov ID: NCT06062498

Single Arm Pilot Trial of Adaptive Therapy (AT) With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, Hormone Refractory Breast Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with ER-positive, HER2-negative metastatic breast cancer refractory to endocrine therapy (no prior chemo/ADCs for MBC, ECOG 0–2) receive oral capecitabine, starting with two standard cycles followed by an adaptive dosing strategy guided by serial imaging and blood-based tumor burden to modulate dose up or down. Capecitabine is a fluoropyrimidine prodrug converted to 5-FU that inhibits thymidylate synthase and is standard in this setting; exclusions include visceral crisis, uncontrolled brain mets, and complete DPD deficiency.

ClinicalTrials.gov ID: NCT06525766

A Randomized Phase II Study of Consolidative Surgery and Radiotherapy With Curative Intent for De Novo Oligometastatic HER2+ Breast Cancer [Ablation and Resection for the Consolidation of Oligometastatic HER2+ Breast Cancer (ARCHER)]

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with de novo oligometastatic (≤5 lesions), non-CNS, HER2-positive breast cancer with disease control after 3–12 months of first-line therapy (typically taxane plus trastuzumab/pertuzumab, HER2-targeted mAbs) are randomized to continue systemic therapy alone versus adding consolidative local therapy with curative intent (breast surgery, locoregional RT, and SBRT to all metastases) while continuing standard HER2-directed therapy. Primary endpoint: progression-free survival.

ClinicalTrials.gov ID: NCT07053085

A Phase I/II, Single Arm, Non-randomized Study of Ribociclib (LEE011), a CDK 4/6 Inhibitor, in Combination With Bicalutamide, an Androgen Receptor (AR) Inhibitor, in Advanced AR+ Triple-negative Breast Cancer: Big Ten Cancer Research Consortium BRE15-024

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial targets patients with advanced AR-positive, triple-negative breast cancer who have undergone up to three prior systemic therapies for metastatic disease, evaluating the combination of ribociclib, a CDK 4/6 inhibitor, and bicalutamide, an androgen receptor inhibitor.

ClinicalTrials.gov ID: NCT03090165

PROMISE-005: A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Breast or Lung Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults with oligometastatic breast cancer (all subtypes) or non-small cell lung cancer (1-5 measurable metastases) who are randomized to receive either standard systemic therapy or standard systemic therapy plus stereotactic body radiotherapy (SBRT) to all metastatic sites. Eligible patients may have newly diagnosed or stable metastatic disease and must have lesions suitable for SBRT or local therapy.

ClinicalTrials.gov ID: NCT03808337