Clinical Trials for Breast Cancer

A Phase Ib/II Trial of Lenvatinib Plus Pembrolizumab Plus Fulvestrant in ER-positive/ HER2- Negative Metastatic 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.

HealthScout AI summary: Eligible patients are adults with unresectable, locally advanced, or metastatic ER-positive, HER2-negative breast cancer who have progressed on prior endocrine therapy with a CDK4/6 inhibitor (allowing up to two prior lines of chemotherapy and stable treated brain metastases), receiving lenvatinib (VEGFR/FGFR/PDGFRα/RET/KIT inhibitor) plus pembrolizumab (PD-1 inhibitor) and fulvestrant. Both premenopausal (with ovarian suppression) and postmenopausal women, as well as men, are eligible.

ClinicalTrials.gov ID: NCT06110793

Phase 1/1B Study of DS-8201a in Combination With ATR Inhibition (AZD6738) in Advanced Solid Tumors With HER2 Expression (DASH Trial)

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic HER2-expressing solid tumors—particularly colorectal and gastroesophageal cancers after progression on standard therapy—and evaluates intravenous trastuzumab deruxtecan (a HER2-targeted antibody-drug conjugate) in combination with oral ceralasertib (a selective ATR kinase inhibitor targeting DNA damage response pathways).

ClinicalTrials.gov ID: NCT04704661

A Phase 3b, Multicenter, Global, Interventional, Open-label Study of Trastuzumab Deruxtecan (T-DXd), an Anti-HER2-Antibody Drug Conjugate (ADC), in Subjects Who Have Unresectable and/or Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer (DESTINY-Breast15)

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.

HealthScout AI summary: This trial enrolls adults with unresectable or metastatic breast cancer that is HER2-low (IHC 1+ or 2+/ISH-) or HER2 IHC 0 (regardless of hormone receptor status), who have had 1-2 prior lines of therapy but no prior anti-HER2 agents or antibody-drug conjugates in the metastatic setting. All patients receive trastuzumab deruxtecan (T-DXd), an antibody-drug conjugate delivering a topoisomerase I inhibitor to HER2-expressing tumor cells, to assess clinical benefit and safety.

ClinicalTrials.gov ID: NCT05950945

"A Phase 2, Double Blinded, Randomized Controlled Trial of Evexomostat (SDX-7320) or Placebo in Combination With Eribulin for Patients With Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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.

HealthScout AI summary: This trial enrolls adults with metastatic triple-negative breast cancer and metabolic dysfunction (HbA1c > 5.5% and/or BMI ≥ 30) who have had up to two prior metastatic therapies, randomizing them to eribulin with either placebo or evexomostat, a polymer-conjugated MetAP2 inhibitor with anti-angiogenic and metabolic modulatory effects. Key exclusions include uncontrolled diabetes and significant cardiac disease.

ClinicalTrials.gov ID: NCT05570253

A Phase II Trial of Stereotactic Body Radiation Therapy and Fluoroestradiol Positron Emission Tomography in Patients With Oligoprogressive Estrogen Receptor Positive Metastatic 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.

HealthScout AI summary: This trial enrolls adults with estrogen receptor positive (ER+) metastatic breast cancer and 1–4 sites of extracranial oligoprogressive disease who are candidates for SBRT to all progressing lesions. Participants receive stereotactic body radiation therapy to progressive sites while remaining on their current systemic therapy, and undergo F-18 fluoroestradiol PET/CT imaging to guide detection and monitoring of ER+ lesions.

ClinicalTrials.gov ID: NCT06260033

A Phase 1 Study of ZEN003694 in Combination With Binimetinib in Solid Tumors With RAS Pathway Alterations and Triple Negative Breast Cancer

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.

HealthScout AI summary: Eligible patients are adults with advanced or metastatic solid tumors harboring RAS pathway alterations (KRAS, NRAS, HRAS, BRAF, or NF1), including those with triple negative breast cancer, who have progressed after standard therapy. Treatment consists of the BET inhibitor ZEN003694 (targets transcriptional regulation) in combination with the MEK inhibitor binimetinib, both given orally.

ClinicalTrials.gov ID: NCT05111561

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Treatment Combinations In Patients With Metastatic Breast Cancer (Morpheus-panBC)

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.

HealthScout AI summary: This umbrella study enrolls adults with metastatic or inoperable locally advanced breast cancer across molecular subtypes (including first- and second-line triple-negative, HR+ PIK3CA-mutant, and HER2+/HER2-low PIK3CA-mutant disease) to randomized arms of standard therapies or novel combinations featuring agents such as atezolizumab (PD-L1 inhibitor), ipatasertib (pan-Akt inhibitor), inavolisib (PI3K inhibitor), sacituzumab govitecan (Trop-2–directed ADC), ladiratuzumab vedotin (anti-LIV-1 ADC), and selicrelumab (CD40 agonist antibody). Treatments are assigned by subtype and prior therapy, with crossover options for select cohorts upon progression.

ClinicalTrials.gov ID: NCT03424005

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.

HealthScout 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.

HealthScout 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.

HealthScout 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