Clinical Trials for Breast Cancer

A Phase II Study of STEMVAC Vaccine Therapy for Patients With Hormone Receptor Positive 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.

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

TrialFetch AI summary: Adults with measurable, biopsy-accessible hormone receptor–positive, HER2-negative or HER2-low metastatic breast cancer receive intradermal STEMVAC while continuing either first- or second-line endocrine therapy plus a CDK4/6 inhibitor or capecitabine after progression on endocrine-based therapy. STEMVAC is an investigational DNA vaccine designed to induce T-cell responses against CD105, YB-1, SOX2, CDH3, and MDM2.

ClinicalTrials.gov ID: NCT07112053

Phase I Evaluation of Combination CLK/DYRK (Cirtuvivint) Inhibition With PARP Inhibition (Olaparib) in BRCA/HRD Platinum Resistant Ovarian 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.

TrialFetch AI summary: For women with platinum-resistant, BRCA-mutated and/or HRD-positive high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer previously treated with platinum chemotherapy and a PARP inhibitor. Treatment combines olaparib with investigational cirtuvivint, a CLK/DYRK inhibitor that alters RNA splicing, to assess tolerability and select a dose and schedule.

ClinicalTrials.gov ID: NCT06856499

A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-023 as a Single Agent, and in Combination With AVZO-021 and/or Endocrine Therapy in Patients With 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.

TrialFetch AI summary: Eligible adults have ECOG performance status 0–1 and either advanced solid tumors with CDK4 or CCND1 amplification or locally advanced/metastatic HR-positive, HER2-negative breast cancer; prior selective CDK inhibitor treatment is excluded. They receive the oral selective CDK4 inhibitor AVZO-023 alone or with the investigational CDK2 inhibitor AVZO-021 and/or endocrine therapy (letrozole or fulvestrant).

ClinicalTrials.gov ID: NCT06998407

ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu: A Single-Center Pilot Study

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: Adults with locally advanced or metastatic breast cancer on ongoing fam-trastuzumab deruxtecan (Enhertu) after 3–4 cycles and experiencing clinician-identified fatigue are randomized to a 12-week, home-based aerobic plus resistance exercise program versus usual care. Enhertu, an anti-HER2 antibody–drug conjugate delivering a topoisomerase I inhibitor to HER2-expressing cells, continues per standard care; the study tests whether structured exercise reduces cancer-related fatigue.

ClinicalTrials.gov ID: NCT07203378

A Phase Ia/Ib Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Patients With Locally Advanced Or Metastatic ER-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After CDK4/6 Inhibitor Therapy

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: For patients with locally advanced or metastatic ER-positive, HER2-negative breast cancer that progressed during or after CDK4/6 inhibitor therapy, this study evaluates oral GDC-0587, a selective CDK4 inhibitor, alone or with giredestrant, an estrogen receptor degrader.

ClinicalTrials.gov ID: NCT07214662

A Phase 1b, Open-Label Parallel Study Evaluating CLR 125 in Patients With Relapsed or Refractory 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.

TrialFetch AI summary: Adults with measurable relapsed or refractory triple-negative breast cancer after at least one standard regimen receive one of three dose levels of CLR 125; patients with treated, stable brain metastases are eligible. CLR 125 is an investigational iodine-125 radiopharmaceutical designed to accumulate in tumors via a phospholipid ether and deliver short-range Auger radiation.

ClinicalTrials.gov ID: NCT07311993

A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies

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 ECOG 0–1 and advanced ER-positive/HER2-negative breast cancer harboring a PIK3CA, AKT1, or PTEN alteration after endocrine therapy, or unresectable/metastatic cutaneous melanoma after checkpoint inhibition, receive oral AMXT 1501 (a polyamine transport inhibitor) plus oral DFMO (an inhibitor of polyamine synthesis). The breast cancer cohort also receives fulvestrant and capivasertib; the melanoma cohort receives pembrolizumab.

ClinicalTrials.gov ID: NCT07287917

Phase 1b Study of Pidnarulex and Trastuzumab Deruxtecan in Patients With HER2 Expressing 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: Adults with previously treated, advanced HER2-expressing solid tumors are eligible for dose escalation; expansion is limited to HER2-low breast cancer or hormone receptor–positive HER2-ultralow breast cancer. Patients receive trastuzumab deruxtecan, a HER2-directed antibody–drug conjugate, plus investigational pidnarulex, which inhibits RNA polymerase I–mediated ribosomal RNA synthesis and may stabilize DNA G-quadruplexes.

ClinicalTrials.gov ID: NCT07137416

Phase I Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6043 in Patients With Advanced/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.

TrialFetch AI summary: Adults with advanced unresectable or metastatic solid tumors after standard therapy, or without a suitable standard option, receive intravenous SYS6043 every 3 weeks. This investigational antibody–drug conjugate targets B7-H3 and delivers a cytotoxic payload; expansion cohorts may include small-cell lung, HR-positive/HER2-negative breast, castration-resistant prostate, and ovarian cancers.

ClinicalTrials.gov ID: NCT07424547

A Phase 1b/2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants With CLDN18.2-expressing Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma, Pancreatic Adenocarcinoma or Other Solid Tumor Types

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: Open-label multicohort study for patients with CLDN18.2-expressing unresectable locally advanced or metastatic gastroesophageal adenocarcinoma, pancreatic adenocarcinoma, or selected other solid tumors after at least one prior systemic therapy and ECOG 0–1. Participants receive IV ASP546C every 3 weeks, a CLDN18.2-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor payload, with dose evaluation in gastroesophageal cancer and higher-dose cohorts in pancreatic and pan-tumor populations.

ClinicalTrials.gov ID: NCT07488676