Clinical Trials for Breast Cancer

A Global, Multicenter, Three Arms, Open-label Randomized Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension Compared to Taxotere® (Docetaxel Injection Concentrate) in Triple-negative Breast Cancer Patients With Locally Advanced or Metastatic Breast Cancer After Failure to Prior Chemotherapy

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.

TrialFetch AI summary: This trial enrolls patients with locally advanced or metastatic triple-negative breast cancer who have progressed after prior chemotherapy, randomizing them to receive either nanosomal docetaxel lipid suspension (a lipid-based docetaxel formulation designed to reduce toxicity and hypersensitivity) at two different doses or standard docetaxel (Taxotere), with all treatments given every 3 weeks until progression or unacceptable toxicity. Prior docetaxel in the metastatic setting and active CNS metastases (except asymptomatic) are exclusion criteria.

ClinicalTrials.gov ID: NCT03671044

Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)

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 melanoma (including those with untreated brain metastases) or triple-negative breast cancer with brain metastases who have progressed after standard therapy, testing the combination of alpelisib (a PI3Kα inhibitor) and pembrolizumab (a PD-1 inhibitor).

ClinicalTrials.gov ID: NCT06545682

A Pharmacodynamics-Driven Trial of Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage Response

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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors harboring deleterious germline or somatic DNA damage response (DDR) gene aberrations who have progressed after standard therapy, including those with prior platinum or PARP inhibitor exposure. Patients receive oral talazoparib, a PARP1/2 inhibitor that exploits defective DNA repair in cancer cells, administered daily in 28-day cycles until disease progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT04550494

Phase 2 Study of Avapritinib in Patients With CKIT or PDGFRA Mutation-Positive Malignant 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.

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 locally advanced or metastatic non-GIST solid tumors (such as melanoma, sarcoma, or primary CNS tumors) harboring activating mutations in CKIT or PDGFRA, who have no effective standard therapy options. Patients receive avapritinib, an oral tyrosine kinase inhibitor selective for CKIT and PDGFRA mutations.

ClinicalTrials.gov ID: NCT04771520

Phase 1b Study of Olaparib and Estradiol in Advanced ER+ Breast Cancer (PHOEBE)

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 post-menopausal women with endocrine-resistant, advanced or recurrent ER-positive, HER2-negative breast cancer who have had at least one prior endocrine therapy in the advanced setting, testing olaparib (a PARP inhibitor that targets DNA repair defects) in combination with 17b-estradiol followed by 17b-estradiol alone.

ClinicalTrials.gov ID: NCT05900895

A Phase Ib/III, Open-label, Randomised Study of Capivasertib Plus CDK4/6 Inhibitors and Fulvestrant Versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

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.

TrialFetch AI summary: This trial enrolls adults with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer who are candidates for fulvestrant and a CDK4/6 inhibitor, and randomizes them to receive either standard therapy (CDK4/6 inhibitor plus fulvestrant) or the addition of capivasertib, an oral AKT inhibitor targeting the PI3K/AKT pathway. Prior use of AKT/PI3K/mTOR inhibitors or CDK4/6 inhibitors in the advanced/metastatic setting are excluded.

ClinicalTrials.gov ID: NCT04862663

Phase II Trial of Palbociclib and Pembrolizumab in Central Nervous System Metastases

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.

TrialFetch AI summary: Adults with progressive, measurable CNS metastases from solid tumors and CDK pathway alterations (Cohort 1) receive palbociclib, a selective CDK4/6 inhibitor, while patients with breast cancer brain metastases (Cohort 2) receive palbociclib plus pembrolizumab, an anti–PD-1 immunotherapy. Prior CNS-directed therapy is allowed; key exclusions include prior CDK4/6 inhibitor use, leptomeningeal disease (Cohort 1), and active autoimmune disease (Cohort 2).

ClinicalTrials.gov ID: NCT02896335

Phase II, Open-Labeled, Single-Armed Combination Treatment With Anastrozole, Fulvestrant and Abemaciclib for Hormone Receptor Positive, HER2(-) Metastatic 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.

TrialFetch AI summary: For postmenopausal adults or those receiving ovarian suppression with hormone receptor positive, HER2-negative metastatic or locally advanced breast cancer (excluding prior fulvestrant, inflammatory, triple-negative, or HER2-positive cases), this trial evaluates the combination of standard endocrine therapy (anastrozole and fulvestrant) with abemaciclib, an oral CDK4/6 inhibitor targeting cell cycle progression. Eligible patients may be newly diagnosed or have relapsed after at least 12 months from prior therapy.

ClinicalTrials.gov ID: NCT05524584

A Pilot Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for Hormone Positive 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.

TrialFetch AI summary: This trial enrolls adult women with hormone receptor-positive, HER2-negative metastatic breast cancer who have progressed after prior endocrine therapy, using a sequential regimen of standard chemotherapy (cyclophosphamide, docetaxel, GM-CSF), followed by either sacituzumab govitecan (Trop-2 antibody-drug conjugate) or trastuzumab deruxtecan (HER2 antibody-drug conjugate), then capecitabine, and finally fulvestrant plus a CDK4/6 inhibitor. Prior fulvestrant or active CNS metastases are exclusion criteria.

ClinicalTrials.gov ID: NCT06409390

A Phase 2 Study of Palliative Radiation in Combination with Pembrolizumab in Subjects with Unresectable Metastatic Stage IV Breast Cancer: Twisted Pink

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.

TrialFetch AI summary: This trial enrolls adult women with unresectable metastatic stage IV breast cancer who have progressed on at least two prior lines of standard therapy, including appropriate agents for their cancer subtype. Participants receive palliative stereotactic body radiation therapy (SBRT) combined with pembrolizumab, a PD-1 inhibitor immunotherapy.

ClinicalTrials.gov ID: NCT04990921