Clinical Trials for Breast Cancer

A Study of PARG Inhibitor IDE161 in Participants 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: This trial enrolls adults with advanced or metastatic solid tumors (excluding primary CNS tumors); for IDE161 monotherapy, patients must have BRCA1/2 or other homologous recombination deficiency gene alterations, while the combination arm is for patients with advanced or recurrent endometrial cancer who have progressed on prior anti–PD-1/L1 therapy. IDE161 is an investigational oral inhibitor of poly(ADP-ribose) glycohydrolase (PARG), targeting DNA repair in HR-deficient tumors, given alone or in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT05787587

A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select 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.

TrialFetch AI summary: Adults with select advanced/metastatic solid tumors after standard therapy (melanoma, cSCC, Merkel cell, NSCLC, HNSCC, gastric/GEJ, RCC, HGSOC, TNBC) receive AZD6750, an investigational CD8-guided IL-2 designed to preferentially activate CD8+ T cells; a separate module enrolls NSCLC (including 1L PD-L1 ≥1%) to receive AZD6750 plus rilvegostomig, a bispecific PD-1/TIGIT antibody. Key exclusions include uncontrolled CNS disease, active autoimmune disease, prior severe I/O toxicities, and in the NSCLC module prior anti-TIGIT or targetable driver-positive 1L disease.

ClinicalTrials.gov ID: NCT07115043

An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BFv; 9MW2821) in Subjects With Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated With Antibody-Drug Conjugates

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 recurrent/metastatic triple‑negative breast cancer previously treated with a taxane and a topoisomerase‑inhibitor ADC (ECOG 0–1) receive bulumtatug fuvedotin (9MW2821), a Nectin‑4–targeted MMAE antibody‑drug conjugate, at two dose levels. Excludes prior MMAE‑based or Nectin‑4 ADC exposure and requires measurable disease and available tissue; explores efficacy with biomarker correlations (including Nectin‑4 expression).

ClinicalTrials.gov ID: NCT06908928

A Phase 1b/2, Open-Label, Multicohort Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced 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: Enrolling adults with previously treated, locally advanced/metastatic breast cancer across HER2+ to HER2-low/ultralow (cohorts by HER2 and HR status, generally after standard HER2 therapies and/or CDK4/6i, PARPi, checkpoint inhibitors, and prior T-DXd as applicable). Single-arm disitamab vedotin (HER2-targeted MMAE antibody–drug conjugate) IV q2w until progression; excludes active CNS disease and prior MMAE ADCs.

ClinicalTrials.gov ID: NCT06966453

A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4/6 Inhibitor

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 ER-positive, HER2-negative locally advanced/metastatic breast cancer who have progressed on prior CDK4/6 inhibitor plus endocrine therapy (ECOG 0–1) are enrolled to receive GDC-4198—an oral next-generation cyclin-dependent kinase inhibitor with potent CDK4 and additional CDK2 activity—alone or with the oral SERD giredestrant, and in Phase II are randomized to GDC-4198 + giredestrant (two dose levels) versus abemaciclib + giredestrant. Excludes visceral crisis requiring chemotherapy and prior chemotherapy for metastatic disease.

ClinicalTrials.gov ID: NCT07100106

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