Clinical Trials for Breast Cancer

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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

A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease

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.

TrialFetch AI summary: Adults with previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (including ER-low/HER2-negative) whose tumors are PD-L1–negative or otherwise ineligible for standard PD-(L)1 inhibitor plus chemotherapy receive physician’s choice chemotherapy (paclitaxel/nab-paclitaxel, gemcitabine/carboplatin, or eribulin). Patients are randomized double-blind to add pumitamig (BNT327), a bispecific anti–PD-L1/anti–VEGF-A antibody (checkpoint blockade plus anti-angiogenic therapy), versus placebo.

ClinicalTrials.gov ID: NCT07173751

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

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.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic HR+/HER2− (including HER-low) breast cancer harboring an activating PIK3CA mutation, with measurable disease or evaluable bone-only disease and no prior systemic therapy for advanced disease (including endocrine-sensitive or endocrine-resistant relapse strata; ovarian/GnRH suppression required when applicable). Randomized double-blind comparison of oral LY4064809 (STX-478/tersolisib), a mutant-selective allosteric PI3Kα inhibitor, plus palbociclib and investigator-choice endocrine therapy (AI or fulvestrant) versus placebo with the same backbone, continued until progression or toxicity.

ClinicalTrials.gov ID: NCT07174336

A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)

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.

TrialFetch AI summary: Adults (women or men) with ER+, HER2− unresectable locally advanced or metastatic breast cancer who are systemic-therapy naïve for advanced disease (de novo or recurrence >12 months after adjuvant endocrine therapy; ECOG 0–1; measurable or bone-only disease; premenopausal women/men require GnRH suppression) are randomized to palazestrant (OP-1250; oral complete ER antagonist/next-generation SERD that promotes ER degradation, including in ESR1-mutant tumors) plus ribociclib versus standard letrozole plus ribociclib in the first-line setting.

ClinicalTrials.gov ID: NCT07085767