Clinical Trials for Breast Cancer

A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or Trastuzumab Deruxtecan (T-DXd) in Patients With Metastatic HER2-negative (HER2-low or HER2-0) Breast Cancer After Progression on Prior Antibody Drug Conjugate Therapy

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.

Active drug

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

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 HER2-negative (HER2-low or HER2-0) breast cancer who have progressed on prior ADC therapy, including those with stable or treated CNS metastases. Patients are randomized to receive either trastuzumab deruxtecan (an anti-HER2 ADC) or datopotamab deruxtecan (an investigational anti-TROP2 ADC), with crossover permitted at progression.

ClinicalTrials.gov ID: NCT06533826

A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer

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.

Active drug

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

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 HR-positive, HER2-negative recurrent or metastatic breast cancer who have progressed after at least two prior endocrine therapies (including a CDK4/6 inhibitor) and no prior chemotherapy in the metastatic setting, to receive alisertib—an oral Aurora A kinase inhibitor—at different dose levels in combination with standard endocrine therapy. Patients must not have received prior Aurora kinase inhibitors.

ClinicalTrials.gov ID: NCT06369285

A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations

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.

Active drug

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

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 metastatic or unresectable solid tumors (excluding NSCLC) harboring activating HER2 mutations, who have progressed on standard therapy or have no satisfactory alternatives. Patients receive BAY2927088, an oral reversible tyrosine kinase inhibitor targeting mutant HER2 and EGFR.

ClinicalTrials.gov ID: NCT06760819

A Phase 3, Randomized, Multi-center, Open-Label Study of DB-1303 Versus Investigator's Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-Low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02)

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.

Active drug

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

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 patients with HR+, HER2-low metastatic breast cancer who have progressed after endocrine therapy and have not received prior chemotherapy for metastatic disease or anti-HER2 therapy, randomizing them to either DB-1303 (a HER2-targeted antibody-drug conjugate with a topoisomerase I inhibitor payload) or standard single-agent chemotherapy.

ClinicalTrials.gov ID: NCT06018337

DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs

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.

Active drug

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

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 HER2-negative metastatic breast cancer (ER-positive or triple-negative) with brain metastases or any HER2-negative subtype with leptomeningeal disease, who receive datopotamab deruxtecan, an anti-TROP2 antibody-drug conjugate delivering a topoisomerase I inhibitor. All participants must have CNS involvement, good performance status, and no major comorbidities; the drug is given IV every 3 weeks.

ClinicalTrials.gov ID: NCT06176261

A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)

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.

Active drug

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

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 untreated, locally advanced or metastatic HR-positive, HER2-negative breast cancer and germline BRCA1, BRCA2, or PALB2 mutations, to compare saruparib (a PARP1-selective inhibitor) plus camizestrant (an oral SERD) versus physician's choice of CDK4/6 inhibitor plus endocrine therapy or plus camizestrant as first-line treatment.

ClinicalTrials.gov ID: NCT06380751

A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)

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.

Active drug

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

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 previously untreated, locally recurrent unresectable or metastatic triple-negative breast cancer with PD-L1 CPS <10, randomizing them to sacituzumab tirumotecan (a TROP2-directed antibody-drug conjugate), sacituzumab tirumotecan plus pembrolizumab (a PD-1 inhibitor), or standard chemotherapy. Eligible patients must be chemotherapy candidates without active CNS metastases or major comorbidities.

ClinicalTrials.gov ID: NCT06841354

An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator's Choice of Therapy in Adult Participants With Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy

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.

Active drug

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

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 locally advanced/metastatic breast cancer after progression on a CDK4/6 inhibitor (no known PIK3CA/AKT1/PTEN alterations; ≤2 prior metastatic lines; no prior chemo/ADC in metastatic setting) are randomized to PF-07248144, a selective KAT6A/6B histone acetyltransferase inhibitor, plus fulvestrant versus everolimus plus endocrine therapy (exemestane or fulvestrant). Assesses progression-free survival, with key secondaries including OS and response; eligibility includes measurable or bone-only disease and ECOG 0–1.

ClinicalTrials.gov ID: NCT07062965

A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor

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.

Active drug

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

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+/HER2− locally advanced/metastatic breast cancer harboring a primary oncogenic PIK3CA mutation after progression on a CDK4/6 inhibitor and endocrine therapy are randomized to fulvestrant plus RLY-2608—an investigational, allosteric, mutant-selective PI3Kα inhibitor—versus fulvestrant plus capivasertib (AKT inhibitor). Excludes prior PI3K/AKT/mTOR therapy, uncontrolled diabetes, significant CV disease, and tumors with activating AKT or PTEN loss.

ClinicalTrials.gov ID: NCT06982521

An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)

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.

Active drug

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

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+/HER2- unresectable locally advanced or metastatic breast cancer with measurable disease and progression after prior CDK4/6 inhibitor plus endocrine therapy are randomized to patritumab deruxtecan (HER3-targeted topoisomerase I antibody-drug conjugate) versus physician’s choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, liposomal doxorubicin) or trastuzumab deruxtecan. Key exclusions include candidates for further endocrine therapy or PARP inhibitor (gBRCA+), visceral crisis, prior chemo for advanced disease, prior anti-HER3 or topo I ADCs, and active ILD/pneumonitis.

ClinicalTrials.gov ID: NCT07060807