Clinical Trials for Breast Cancer

A Phase I/II, Dose-escalation and Dose-optimization Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MT-4561 in Patients With Various Advanced Solid Tumors and to Evaluate Effect of MT-4561 on Pharmacokinetics of Oral Midazolam

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: Adults with selected advanced solid tumors, measurable disease, and ECOG performance status 0–1 receive once-weekly intravenous MT-4561, an investigational drug designed to degrade BRD4. Dose escalation is followed by planned dose optimization and an assessment of MT-4561’s effect on oral midazolam pharmacokinetics.

ClinicalTrials.gov ID: NCT06943521

A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ENV-501 in Patients With Advanced-Stage, Relapsed/Refractory HER3-Expressing 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: Patients with advanced or metastatic HER3-positive solid tumors, including cutaneous melanoma, EGFR-mutated non–small cell lung cancer, and HR-positive/HER2-negative breast cancer, may be eligible if they are relapsed or refractory to standard therapy or have no suitable standard option. Treatment is intravenous ENV-501 every 3 weeks, an investigational HER3-targeted antibody–drug conjugate carrying the topoisomerase I inhibitor exatecan.

ClinicalTrials.gov ID: NCT06956690

A Phase 1a/1b, Multicenter, Open-label, Dose Escalation/Expansion, Multiple-dose Study to Evaluate the Safety and Activity of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas

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: Patients with measurable, unresectable locally advanced or metastatic epithelial carcinomas that have relapsed or are refractory after at least two prior treatment lines, have no standard options, and have ECOG performance status 0–1 receive DR-0202 every two weeks. DR-0202 is an investigational bispecific antibody designed to bring myeloid immune cells into contact with tumor cells; its tumor-cell target has not been disclosed.

ClinicalTrials.gov ID: NCT06999187

NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated 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: Adults with previously treated, progressing locally advanced or metastatic urothelial cancer enter dose escalation; expansion enrolls patients with Nectin-4–positive solid tumors identified by [64Cu]Cu-AKY-1189 imaging. All receive up to six cycles of [225Ac]Ac-AKY-1189, a Nectin-4–targeted radiopharmaceutical that delivers actinium-225 to tumor cells.

ClinicalTrials.gov ID: NCT07020117

A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants 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: Adults with PIK3CA-mutated, unresectable or metastatic solid tumors after at least one prior therapy receive oral ETX-636, an investigational mutant-selective PI3Kα inhibitor, as monotherapy. Patients with HR-positive, HER2-negative advanced breast cancer previously treated with a CDK4/6 inhibitor and anti-estrogen therapy may receive ETX-636 plus fulvestrant.

ClinicalTrials.gov ID: NCT06993844

Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab + Neoantigen Vaccine Vs. Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer

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 newly diagnosed, untreated metastatic triple negative breast cancer that is negative for PD-L1, evaluating nab-paclitaxel plus durvalumab (PD-L1 inhibitor) and tremelimumab (CTLA-4 inhibitor), with or without the addition of a personalized neoantigen peptide vaccine plus poly-ICLC as an immunologic adjuvant. Patients must have accessible tumor tissue, good performance status, and meet organ function requirements.

ClinicalTrials.gov ID: NCT03606967

A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

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 ER-positive, HER2-negative advanced or metastatic breast cancer previously treated with endocrine therapy (and CDK4/6 inhibitors depending on arm) to evaluate the safety and efficacy of elacestrant, an oral selective estrogen receptor degrader, in combination with various targeted agents including alpelisib (PI3K inhibitor), everolimus (mTOR inhibitor), palbociclib/abemaciclib/ribociclib (CDK4/6 inhibitors), and capivasertib (AKT inhibitor). Key exclusions are active CNS disease, symptomatic visceral crisis, and prior use of elacestrant or the relevant combination partner in the metastatic setting.

ClinicalTrials.gov ID: NCT05563220

An Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of XL309 (ISM3091) as Single-Agent and Combination Therapy in 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: Adults with advanced solid tumors, particularly BRCA1/2-mutated or other homologous-recombination–deficient cancers, receive oral XL309, an investigational USP1 inhibitor that disrupts DNA repair, alone or with the PARP inhibitor olaparib. Cohorts include breast, castration-resistant prostate, pancreatic, and platinum-sensitive or platinum-resistant ovarian cancer.

ClinicalTrials.gov ID: NCT05932862

Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax

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 advanced or metastatic hepatocellular, renal cell, breast, ovarian/fallopian, or endometrial/primary peritoneal cancers involving the abdomen or thorax who have progressed on or are intolerant to standard therapies, and evaluates safety of Tumor Treating Fields (TTF) in combination with either cabozantinib (a multi-kinase inhibitor targeting MET, VEGFR, and AXL) or nab-paclitaxel plus atezolizumab (a PD-L1 inhibitor).

ClinicalTrials.gov ID: NCT05092373

Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With 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: Adults with relapsed or refractory triple-negative breast cancer and measurable or evaluable disease receive cyclophosphamide/fludarabine lymphodepletion followed by autologous CAR T cells targeting B7-H3 (CD276). The cells include an inducible caspase-9 safety switch designed to allow their elimination if serious toxicity occurs.

ClinicalTrials.gov ID: NCT06347068