Clinical Trials for Breast Cancer

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Treatment Combinations In Patients With Metastatic Breast Cancer (Morpheus-panBC)

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.

HealthScout AI summary: This umbrella study enrolls adults with metastatic or inoperable locally advanced breast cancer across molecular subtypes (including first- and second-line triple-negative, HR+ PIK3CA-mutant, and HER2+/HER2-low PIK3CA-mutant disease) to randomized arms of standard therapies or novel combinations featuring agents such as atezolizumab (PD-L1 inhibitor), ipatasertib (pan-Akt inhibitor), inavolisib (PI3K inhibitor), sacituzumab govitecan (Trop-2–directed ADC), ladiratuzumab vedotin (anti-LIV-1 ADC), and selicrelumab (CD40 agonist antibody). Treatments are assigned by subtype and prior therapy, with crossover options for select cohorts upon progression.

ClinicalTrials.gov ID: NCT03424005

A Phase I/II, Single Arm, Non-randomized Study of Ribociclib (LEE011), a CDK 4/6 Inhibitor, in Combination With Bicalutamide, an Androgen Receptor (AR) Inhibitor, in Advanced AR+ Triple-negative Breast Cancer: Big Ten Cancer Research Consortium BRE15-024

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.

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 targets patients with advanced AR-positive, triple-negative breast cancer who have undergone up to three prior systemic therapies for metastatic disease, evaluating the combination of ribociclib, a CDK 4/6 inhibitor, and bicalutamide, an androgen receptor inhibitor.

ClinicalTrials.gov ID: NCT03090165

Phase I/IIa Clinical Trial Evaluating the Safety and Efficacy of Rintatolimod Combined With IFNα2b (Bioferon®) to Enhance the Effectiveness of Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer

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

HealthScout AI summary: This trial involves adult patients with unresectable or metastatic triple negative breast cancer, investigating a combination of rintatolimod (TLR3 pathway agonist), celecoxib, and interferon alpha-2b with pembrolizumab to enhance treatment efficacy.

ClinicalTrials.gov ID: NCT05756166

PNV21-001: A Phase I Study of a Personalized Multi-Peptide Neo-Antigen Vaccine in Breast Cancer, PD1/PD-L1 Inhibitor-Refractory Melanoma, and Pretreated Non-Small Cell Lung 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.

HealthScout AI summary: This trial evaluates a personalized multi-peptide neo-antigen vaccine combined with poly ICLC and the PD-1 inhibitor nivolumab in adult patients with advanced, treatment-resistant stage IIIC-IV melanoma, hormone receptor positive HER2-negative metastatic breast cancer, and stage III-IV non-small cell lung cancer, focusing on safety and immune response.

ClinicalTrials.gov ID: NCT05098210

PROMISE-005: A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Breast or Lung Cancer

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.

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 oligometastatic breast cancer (all subtypes) or non-small cell lung cancer (1-5 measurable metastases) who are randomized to receive either standard systemic therapy or standard systemic therapy plus stereotactic body radiotherapy (SBRT) to all metastatic sites. Eligible patients may have newly diagnosed or stable metastatic disease and must have lesions suitable for SBRT or local therapy.

ClinicalTrials.gov ID: NCT03808337

PROCLAIM: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer

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.

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 locally advanced or metastatic NSCLC, ovarian, or breast cancer receiving carboplatin-based chemotherapy who have thrombocytopenia (platelets ≤85 x 10^9/L), and randomizes them to weekly subcutaneous romiplostim—a thrombopoietin receptor agonist that stimulates platelet production—versus placebo to assess the prevention of chemotherapy dose delays or reductions.

ClinicalTrials.gov ID: NCT03937154

A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors

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

HealthScout AI summary: Eligible patients are adults with select advanced or metastatic solid tumors (including colorectal, cholangiocarcinoma, appendiceal, pancreatic, gastric, endometrial, triple negative breast, ovarian, or prostate cancers) who have exhausted standard therapies; phase 2 focuses on colorectal cancer. Therapy is with APL-5125, an oral CK2α kinase inhibitor targeting Wnt signaling.

ClinicalTrials.gov ID: NCT06399757

A Phase 1a/1b Open-label, Dose-Escalation and Expansion Study of ACTM-838 as a Single Agent in Patients With Advanced Solid Tumors

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 who have exhausted standard treatment options, testing the investigational single-agent ACTM-838 (mechanism of action not specified) as monotherapy. Eligible patients must have measurable disease, good performance status, adequate organ function, and CD4 counts >500/mL.

ClinicalTrials.gov ID: NCT06336148

Phase 1b/2 Study of Naxitamab (Danyelza), Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells in Advanced GD2-expressing Breast Cancers (DiG NKs)

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 HER2-negative, metastatic, GD2-expressing breast cancer after at least one prior systemic therapy, testing combinations of gemcitabine chemotherapy with investigational TGFβ-imprinted allogeneic NK cells (engineered to overcome TGF-beta immunosuppression) and/or naxitamab, a GD2-targeting monoclonal antibody.

ClinicalTrials.gov ID: NCT06026657

Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mutated Advanced Solid Tumors, With a Focus on Gynecological, Breast, Pancreatic and KEAP1 Mutated Non-small Cell Lung 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.

HealthScout AI summary: This trial enrolls adults with advanced solid tumors harboring KRAS G12C mutations—particularly pancreatic, breast, uterine, or epithelial ovarian cancers, and non-small cell lung cancer with combined KRAS G12C and KEAP1 mutations—who have progressed after prior therapy, and treats them with the combination of adagrasib (a selective irreversible KRAS G12C inhibitor) and olaparib (a PARP inhibitor).

ClinicalTrials.gov ID: NCT06130254