Clinical Trials for Breast Cancer

A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to Trastuzumab in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, or Are Intolerant to, Previous Trastuzumab Deruxtecan 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: This trial enrolls adults with unresectable or metastatic HER2-positive breast cancer who have progressed on or are intolerant to prior trastuzumab deruxtecan, randomizing them to zanidatamab (a bispecific anti-HER2 antibody) plus physician’s choice chemotherapy versus trastuzumab plus physician’s choice chemotherapy. Patients may have stable or treated CNS metastases, and chemotherapy options include eribulin, vinorelbine, gemcitabine, or capecitabine.

ClinicalTrials.gov ID: NCT06435429

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced 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.

TrialFetch AI summary: This study enrolls patients with advanced ER+/HER2− breast cancer progressing after a CDK4/6 inhibitor, platinum-resistant or refractory CCNE1-amplified ovarian, fallopian tube, or primary peritoneal cancer, or other CCNE1-amplified solid tumors progressing after standard therapy. Patients receive the investigational CDK2 inhibitor INX-315 alone, with fulvestrant, or with fulvestrant and abemaciclib, depending on the cohort.

ClinicalTrials.gov ID: NCT05735080

A RANDOMIZED, PHASE II STUDY OF ENZALUTAMIDE, ENZALUTAMIDE WITH MIFEPRISTONE, and TREATMENT OF PHYSICIAN'S CHOICE IN PATIENTS WITH AR+ METASTATIC TRIPLE-NEGATIVE OR ER-LOW 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: This trial enrolls adults with unresectable or metastatic AR-positive triple-negative or ER-low breast cancer (≥10% AR by IHC), randomized to receive either enzalutamide (androgen receptor inhibitor), enzalutamide plus mifepristone (glucocorticoid receptor antagonist), or standard single-agent chemotherapy. Patients may have received up to two prior metastatic chemotherapy lines and may cross over to the investigational arm at progression if eligible.

ClinicalTrials.gov ID: NCT06099769

A Phase 1b Trial of ZEN003694 (ZEN-3694) With Pembrolizumab and Nab-Paclitaxel in Patients With Metastatic 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.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic triple-negative breast cancer receive oral ZEN-3694, an investigational BET protein inhibitor, with pembrolizumab and nab-paclitaxel. Dose expansion is limited to patients with PD-L1-negative disease and no more than one prior metastatic systemic therapy; prior metastatic checkpoint inhibitor or taxane therapy is excluded.

ClinicalTrials.gov ID: NCT05422794

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 as a Single Agent and in Combination in Patients With MTAP-deleted 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 previously treated, unresectable locally advanced or metastatic solid tumors and confirmed MTAP loss receive oral vopimetostat (TNG462), an investigational PRMT5 inhibitor designed to exploit methylthioadenosine accumulation in MTAP-deleted tumors. Some cohorts receive it with the anti–PD-1 antibody pembrolizumab, including an NSCLC expansion cohort.

ClinicalTrials.gov ID: NCT05732831

Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy (BOSS)

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 adult women with metastatic, non–triple-negative breast cancer who have 1-3 extracranial oligoprogressive lesions despite ongoing benefit from current systemic therapy, treating these lesions with stereotactic body radiotherapy (SBRT) while patients remain on their existing systemic regimen. Eligible patients must have adequate performance status, no active CNS disease, and no more than three extracranial progressing sites.

ClinicalTrials.gov ID: NCT06055881

Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE)

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 postmenopausal women with ER+/HER2- metastatic or recurrent breast cancer who have progressed after CDK4/6 inhibitor therapy, assigning patients to combinations of fulvestrant with targeted agents (neratinib for ERBB2 mutations, alpelisib for PIK3CA mutations, everolimus for AKT1/MTOR/PTEN alterations, or abemaciclib for others) based on tumor genetic profiling. Targeted agents address specific molecular drivers: neratinib (pan-HER TKI), alpelisib (PI3K alpha inhibitor), everolimus (mTOR inhibitor), and abemaciclib (CDK4/6 inhibitor).

ClinicalTrials.gov ID: NCT05933395

A Multicenter, Open-Label, Single-Arm, Phase II Trial Exploring the Maintenance of Trastuzumab and Pertuzumab Following Trastuzumab Deruxtecan as Induction Treatment for HER2+ Unresectable Locally Recurrent or 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.

TrialFetch AI summary: This trial enrolls adults with HER2-positive unresectable locally recurrent or metastatic breast cancer (ECOG 0-1) who have not received prior chemotherapy or HER2-targeted therapy for advanced disease, and tests intravenous trastuzumab deruxtecan (a HER2-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor) as induction, followed by maintenance therapy with subcutaneous fixed-dose pertuzumab and trastuzumab (PHESGO).

ClinicalTrials.gov ID: NCT06172127

A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected Advanced 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 advanced or metastatic solid tumors that have progressed on standard therapy or cannot receive it are treated with the oral selective CDK2 inhibitor INCB123667, which targets cyclin E1–CDK2–mediated cell-cycle progression. It is given alone or with palbociclib, ribociclib, fulvestrant, bevacizumab, olaparib, or paclitaxel, with combination cohorts focused on HR-positive/HER2-negative breast and epithelial ovarian cancers.

ClinicalTrials.gov ID: NCT05238922

Open-label Single-arm Phase 2 Trial of Trastuzumab Deruxtecan in Previously Treated HER2-Immunohistochemistry (IHC) 0 Advanced 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: This trial enrolls adults with unresectable or metastatic breast cancer strictly classified as HER2-IHC 0 (never HER2-positive or HER2-low), who have received 1–2 prior lines of systemic therapy and no prior anti-HER2 therapy, to evaluate trastuzumab deruxtecan (T-DXd), a HER2-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor, given IV every 3 weeks.

ClinicalTrials.gov ID: NCT06750484