Clinical Trials for Breast Cancer

A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS014, a HER2-Targeting Antibody Drug Conjugate (ADC), in Participants With Advanced HER2+ 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/metastatic HER2-expressing solid tumors (HER2-positive or HER2-low), including breast and gastric/GEJ cancers after standard therapies, receive IKS014, a HER2-targeting antibody–drug conjugate using a trastuzumab backbone linked to the microtubule inhibitor MMAF. Open-label dose escalation/expansion treats in 21-day cycles until progression to establish RP2D and assess antitumor activity.

ClinicalTrials.gov ID: NCT05872295

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 metastatic HR-positive, HER2-negative/low breast cancer receive STEMVAC, an intradermal multi-antigen plasmid DNA vaccine (targets CD105, YB-1, SOX2, CDH3, MDM2; GM-CSF–adjuvanted to elicit T-cell responses against cancer stem cell–associated proteins), added to either ongoing endocrine therapy plus a CDK4/6 inhibitor (first/second line) or to capecitabine after progression on endocrine therapy. Suitable for ECOG 0–1 patients with measurable disease; includes serial biopsies and immunologic monitoring.

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: Adults with platinum-resistant high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer that is BRCA-mutated and/or HRD-positive, with prior PARP inhibitor exposure and ≤3 prior lines, receive olaparib plus cirtuvivint. Cirtuvivint is an oral CLK/DYRK inhibitor that modulates pre-mRNA splicing and downregulates Wnt-pathway gene expression; two intermittent dosing schedules are tested with continuous olaparib 300 mg BID.

ClinicalTrials.gov ID: NCT06856499

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 adults with locally advanced/metastatic ER-positive, HER2-negative breast cancer with RECIST-evaluable disease and ECOG 0–1 who progressed during/after prior CDK4/6 inhibitor therapy (no visceral crisis requiring urgent chemotherapy), this study tests oral GDC-0587, an investigational selective CDK4 inhibitor, as monotherapy or combined with giredestrant, an oral selective estrogen receptor degrader. Key aims are to define safety/PK and recommended doses, with a cohort assessing food and proton pump inhibitor (omeprazole) effects on GDC-0587 exposure.

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: Enrolls adults with measurable relapsed/refractory triple-negative breast cancer (ER/PR <10%, HER2–) after at least one prior standard regimen (including chemo/immunotherapy and ADCs as applicable), ECOG 0–2; stable treated brain metastases allowed. Patients receive IV CLR 125, an iodine-125–labeled phospholipid ether tumor-targeted radiotherapeutic that accumulates in tumor membranes to deliver short-range Auger-electron radiation, given as 4 fractionated doses per 8-week cycle with dose-level cohorts; an optional sub-study gives a single imaging dose of iopofosine I-131 (CLR 131) for dosimetry.

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: For adults with ECOG 0–1 and measurable unresectable/metastatic disease, this study enrolls either ER+/HER2− breast cancer with actionable PIK3CA/AKT1/PTEN alterations after progression on ≥2 endocrine-based regimens (candidate for fulvestrant + capivasertib) or cutaneous melanoma progressing after prior immune checkpoint inhibitor therapy (and after/intolerant to BRAF/MEK inhibitors if BRAF V600–mutant). Patients receive dual polyamine blockade with oral AMXT 1501 (polyamine transport inhibitor) plus oral DFMO/eflornithine (irreversible ornithine decarboxylase inhibitor) added to standard therapy—fulvestrant + capivasertib in breast cancer or pembrolizumab in melanoma.

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: Enrolling adults with locally advanced/unresectable or metastatic HER2-expressing solid tumors (dose escalation includes HER2+ and breast cancer across HER2-positive/low/ultralow; expansion limited to HER2-low breast cancer [IHC 1+ or 2+/ISH−] or HR+ HER2-ultralow) who have had at least one prior cytotoxic chemotherapy line and have ECOG ≤2, adequate organ function, and LVEF ≥50% (selected stable/treated brain metastases allowed; ILD/pneumonitis risk excluded). Treatment is single-arm trastuzumab deruxtecan IV day 1 every 21 days plus pidnarulex (CX-5461; investigational G-quadruplex–stabilizing DNA-damage/DDR-targeting agent) IV day 8, continued until progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT07137416

PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial

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 solid tumors or metastatic breast cancer (arm-specific eligibility, some requiring HER2 expression or prior HER2 therapy) receive investigational combinations including evorpacept (CD47/SIRPα blocker) plus trastuzumab deruxtecan, or zanidatamab (bispecific anti‑HER2) plus tucatinib (HER2 TKI), with dose-finding and expansion to assess safety and preliminary activity. Arms may prioritize patients previously treated with HER2-directed therapies, including T-DXd.

ClinicalTrials.gov ID: NCT05868226

Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)

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: The INSIGHT trial investigates early chemotherapy with capecitabine versus endocrine-based therapy in patients with non-Luminal A hormone receptor-positive metastatic breast cancer who have previously been treated with aromatase inhibitors, CDK4/6 inhibitors, or selective estrogen receptor modulators/downregulators, but not chemotherapy in the metastatic setting. The study aims to evaluate the anti-tumor effects, safety, and tolerability of these treatments while assessing cfDNA mutations as early indicators of response and potential genomic alterations linked to treatment resistance.

ClinicalTrials.gov ID: NCT05693766