Clinical Trials for Breast Cancer

SHARON: Study of Metastatic Cancers in Patients With a Defect in a Homologous Recombination Gene Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives

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 trial enrolls adults with metastatic pancreatic (ductal or acinar) or HER2-negative breast cancer harboring BRCA1, BRCA2, or PALB2 mutations, and treats them with high-dose melphalan and BCNU in combination with vitamin B12b, escalating doses of vitamin C, and low-dose ethanol, followed by autologous hematopoietic stem cell rescue. The investigational regimen aims to overcome drug resistance in homologous recombination-deficient tumors by exploiting oxidative stress pathways.

ClinicalTrials.gov ID: NCT04150042

A Phase 1 Study of MOMA-313 Given as Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 harboring homologous recombination deficiency (HRD), investigating the safety and activity of the investigational oral polymerase theta (Polθ) helicase inhibitor MOMA-313 as monotherapy or in combination with the PARP inhibitor olaparib. Eligible combination therapy patients include those with metastatic prostate, breast, or pancreatic cancer and must be PARP inhibitor naive.

ClinicalTrials.gov ID: NCT06545942

A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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, measurable solid tumors (including NSCLC and head and neck squamous cell carcinoma), evaluating intravenous TUB-030, an antibody-drug conjugate targeting the 5T4 oncofetal antigen and delivering a topoisomerase I inhibitor, in patients with ECOG 0-1 and adequate organ function. Patients may have clinically stable brain metastases and must have completed prior therapies.

ClinicalTrials.gov ID: NCT06657222

An Open-label, Multi-center, Phase I/II Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 hormone receptor-positive, HER2-negative breast cancer who have progressed on prior endocrine therapy and CDK4/6 inhibitors, as well as those with advanced solid tumors harboring CCNE1 amplification, and investigates the investigational agent ECI830 (mechanism not publicly disclosed) given alone or with ribociclib and fulvestrant.

ClinicalTrials.gov ID: NCT06726148

A Phase 1/2, First-in-Human, Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 solid tumors—including HER2-negative metastatic breast cancer, mCRPC, advanced pancreatic cancer, and platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer—who have progressed after standard therapy. Patients receive NUV-1511, an investigational drug-drug conjugate designed to selectively deliver a cytotoxic payload to tumor cells to enhance efficacy and limit systemic toxicity.

ClinicalTrials.gov ID: NCT06334432

A Phase 1, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants With Advanced Breast Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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, incurable breast cancer who have progressed after at least one line of endocrine therapy (including prior CDK4/6 inhibitor plus fulvestrant or aromatase inhibitor), testing the KAT6A/B inhibitor MEN2312 as monotherapy and in combination with the oral SERD elacestrant. Prior chemotherapy and antibody-drug conjugates are permitted, but patients with new/active brain metastases or severe organ involvement are excluded.

ClinicalTrials.gov ID: NCT06638307

Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an Anti- αvβ3 Integrin Cytotoxin, in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 metastatic triple negative breast cancer (ER/PR <10%, HER2 negative) who have progressed after at least two prior systemic therapies, and evaluates intravenous ProAgio—a pegylated peptide cytotoxin targeting αvβ3 integrin on tumor stroma—combined with gemcitabine. Prior gemcitabine for metastatic disease is excluded.

ClinicalTrials.gov ID: NCT06460298

A Phase 1, Open-Label, Dose-Escalation and Expansion Study of AGX101, a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 patients are adults with unresectable, locally advanced, or metastatic solid tumors who have exhausted standard therapies, good performance status (ECOG 0-1), and adequate organ function. The investigational agent is AGX101, a TM4SF1-targeted antibody-drug conjugate delivering a maytansinoid payload to tumor and tumor vasculature cells.

ClinicalTrials.gov ID: NCT06440005

Adoptive Immunotherapy for Advanced MUC1* Positive Breast Cancer With Autologous T Cells Engineered to Express a Chimeric Antigen Receptor, huMNC2-CAR44 or huMNC2-CAR22, Specific for a Cleaved Form of MUC1 (MUC1*)

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 trial enrolls adults with metastatic breast cancer whose tumors express MUC1* (≥30% of cells), who have progressed on standard therapies, to receive autologous CAR T cell therapy (huMNC2-CAR44 or huMNC2-CAR22) targeting the cleaved MUC1* isoform. Cohorts include hormone receptor positive/HER2 negative, HER2-positive, and triple negative subtypes.

ClinicalTrials.gov ID: NCT04020575

A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By Genomics (CHARGE)

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 trial enrolls adults with metastatic or locally advanced, unresectable triple-negative breast cancer (TNBC) or recurrent, unresectable serous ovarian cancer who have not previously received CDK4/6 or HDAC inhibitors, and tests the combination of ribociclib (a CDK4/6 inhibitor) with belinostat (a pan-HDAC inhibitor). Dose escalation includes both TNBC and ovarian cancer patients, while dose expansion is limited to TNBC.

ClinicalTrials.gov ID: NCT04315233