Clinical Trials for Breast Cancer

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 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

Overcoming PARP Inhibitor Resistance in BRCA Germline Mutation Positive Advanced 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.

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: Eligible patients are adult women with HER2-negative, germline BRCA-mutated advanced or metastatic breast cancer previously treated with a PARP inhibitor, randomized to olaparib plus cediranib (a VEGFR 1/2/3 tyrosine kinase inhibitor targeting angiogenesis) or olaparib plus ceralasertib (an ATR kinase inhibitor targeting the DNA damage response pathway). Both regimens are oral and require patients to have measurable disease and good performance status.

ClinicalTrials.gov ID: NCT04090567

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

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

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.

TrialFetch AI summary: Adults with measurable, unresectable locally advanced or metastatic solid tumors that have progressed after standard therapies, enrolled in tumor-specific refractory cohorts (e.g., melanoma post–PD-(L)1, SCCHN post platinum/PD-(L)1, HER2-negative gastric/GEJ, HGS ovarian, cervical, endometrial, urothelial, ESCC, pancreatic, mCRPC, nonsquamous NSCLC without drivers, and HR+/HER2– breast cancer after CDK4/6 and chemo). Single-arm therapy is patritumab deruxtecan (HER3-DXd) 5.6 mg/kg IV q3w, an HER3-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor (DXd).

ClinicalTrials.gov ID: NCT06172478

A Phase IIIb, Open-label, Multinational Study Assessing the Efficacy and Safety of Dato-DXd Treatment in Patients With HRpositive, HER2 IHC 0, Locally Advanced Inoperable or Metastatic Breast Cancer Refractory to Endocrine Therapy (TROPION-Breast06)

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

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.

TrialFetch AI summary: Enrolls adults with endocrine-refractory HR-positive (ER and/or PgR ≥1%), HER2 IHC 0 locally advanced inoperable or metastatic breast cancer, ECOG 0–1, with no prior chemotherapy for metastatic disease and no prior TROP2-targeted or topoisomerase I inhibitor–containing therapy. All participants receive datopotamab deruxtecan 6 mg/kg IV every 3 weeks, a TROP2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor (DXd) payload, continued until progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT07205822

A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer

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 recurrent metastatic breast cancer of any subtype who have progressed after all standard therapies, including those with stable brain metastases, to receive an HLA-matched, off-the-shelf allogeneic cellular immunotherapy (Bria-OTS, designed to induce anti-tumor immune responses), given alone or in combination with cyclophosphamide, peginterferon alpha-2a, and the PD-1 inhibitor tislelizumab.

ClinicalTrials.gov ID: NCT06471673

Open-Label Umbrella Study to Evaluate Safety and Efficacy of Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced or Metastatic Breast Cancer

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: Enrolling women with previously treated HR+/HER2− advanced/metastatic breast cancer, ECOG 0–1, with measurable/evaluable disease and no prior PI3K/AKT/mTOR inhibitor exposure. Treatment is fulvestrant plus oral PIKTOR, a dual PI3K/mTOR pathway blockade regimen combining serabelisib, a PI3K-alpha inhibitor, and sapanisertib, an mTORC1/2 kinase inhibitor, with dose escalation focused on safety and recommended dosing.

ClinicalTrials.gov ID: NCT07558733

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors

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.

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 evaluates MDNA11, an IL-2 Superkine targeting the IL-2 beta receptor to enhance anti-tumor immunity, administered alone or with pembrolizumab, in adult patients with locally advanced or metastatic solid tumors. Eligible patients must have an ECOG performance status of 0 or 1 and adequate organ function.

ClinicalTrials.gov ID: NCT05086692

A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer and Other 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.

TrialFetch AI summary: This trial involves patients with metastatic or unresectable non-small cell lung cancer and other solid tumors who receive BL-B01D1, a bispecific antibody-drug conjugate targeting EGFR and HER3, designed with a novel topoisomerase I inhibitor payload. The study evaluates different dosing schedules to determine safety, tolerability, and efficacy, particularly aiming to optimize dosing based on promising response rates in EGFR-mutated NSCLC and other cancer types.

ClinicalTrials.gov ID: NCT05983432