Clinical Trials for Breast Cancer

A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Cyclin A/B-RxL Inhibitor CID-078 in Patients With Advanced Solid Tumor Malignancies

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.

HealthScout AI summary: This trial enrolls adults and adolescents (≥12 years, ≥40 kg) with advanced or metastatic solid tumors refractory to standard therapy—including dedicated cohorts for TNBC, SCLC, and tumors with RB1 alteration—for treatment with CID-078, a first-in-class oral macrocyclic inhibitor that blocks cyclin A/B-RxL interactions to induce cell cycle arrest. All patients receive CID-078 monotherapy in 21-day cycles.

ClinicalTrials.gov ID: NCT06577987

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.

HealthScout 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.

HealthScout 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.

HealthScout 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.

HealthScout 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.

HealthScout 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.

HealthScout 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

A Phase I Dose Escalation and Dose Expansion Study of AND019 in Patients With Estrogen Receptor Positive Human Epidermal Growth Factor Receptor 2 Negative Advanced or Metastatic 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.

HealthScout AI summary: This trial enrolls postmenopausal women with advanced or metastatic ER-positive, HER2-negative breast cancer who have progressed on prior endocrine therapy and no more than one chemotherapy for advanced disease, to receive oral AND019, an investigational selective estrogen receptor degrader (SERD) targeting the estrogen receptor. The study focuses on evaluating the safety and early activity of AND019 as monotherapy.

ClinicalTrials.gov ID: NCT05187832

A Phase II Study of NirAparib, Dostarlimab and Radiotherapy in Metastatic, PD-L1 Negative or Immunotherapy-Refractory Triple-Negative Breast Cancer (NADiR)

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.

HealthScout AI summary: This trial enrolls adults with metastatic or recurrent triple-negative breast cancer who are PD-L1 negative or have progressed after immune checkpoint inhibitor therapy (excluding those with known BRCA mutations), treating them with the PARP inhibitor niraparib, the PD-1 inhibitor dostarlimab, and localized radiation. Suitable patients must have had no more than two prior systemic therapies for metastatic disease and require radiation for palliation or local control.

ClinicalTrials.gov ID: NCT04837209

A Phase I Trial of T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

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.

HealthScout AI summary: This trial enrolls adults with metastatic or refractory/recurrent KK-LC-1 positive epithelial cancers (including gastric, breast, cervical, lung, and others) who are also HLA-A*01:01 positive and have adequate organ function. Patients receive lymphodepleting chemotherapy followed by a single infusion of autologous T cells genetically engineered to express a TCR targeting the cancer germline antigen KK-LC-1, along with high-dose aldesleukin to support T cell activity.

ClinicalTrials.gov ID: NCT05035407