Clinical Trials for Breast Cancer

A Randomized Phase II Study of Consolidative Surgery and Radiotherapy With Curative Intent for De Novo Oligometastatic HER2+ Breast Cancer [Ablation and Resection for the Consolidation of Oligometastatic HER2+ Breast Cancer (ARCHER)]

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.

TrialFetch AI summary: Adults with de novo oligometastatic (≤5 lesions), non-CNS, HER2-positive breast cancer with disease control after 3–12 months of first-line therapy (typically taxane plus trastuzumab/pertuzumab, HER2-targeted mAbs) are randomized to continue systemic therapy alone versus adding consolidative local therapy with curative intent (breast surgery, locoregional RT, and SBRT to all metastases) while continuing standard HER2-directed therapy. Primary endpoint: progression-free survival.

ClinicalTrials.gov ID: NCT07053085

A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or 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.

TrialFetch AI summary: Adults with PIK3CA-mutated, ER-positive/HER2-negative locally advanced (recurrent/progressed) or metastatic breast cancer with measurable/evaluable disease who progressed on/after CDK4/6 inhibitor plus endocrine therapy and have had ≤1 prior systemic line in the advanced setting (no prior PI3K/AKT/mTOR inhibitors; diabetes requiring systemic therapy excluded). Participants are randomized to two oral dose levels of inavolisib (PI3Kα inhibitor targeting activating PIK3CA mutations) each combined with intramuscular fulvestrant, with efficacy and tolerability compared.

ClinicalTrials.gov ID: NCT07368998

Artificial Intelligence and Machine Learning-Enhanced Biomarker-dRiven CDK4/6 Inhibitor Rechallenge in HR+ HER2- Advanced Breast 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.

TrialFetch AI summary: Adults with endocrine-sensitive unresectable/metastatic HR+/HER2− breast cancer and ECOG 0–2 who progressed after ≥6 months of prior metastatic CDK4/6 inhibitor therapy (or within 6 months of adjuvant CDK4/6i+endocrine therapy) undergo post-CDK4/6i tumor NGS and are eligible only if an AI/ML model (palbo-VNN) predicts CDK4/6 inhibitor sensitivity. AI-selected patients are randomized to rechallenge with a different CDK4/6 inhibitor (CDK4/6 blockade of G1–S transition) plus fulvestrant versus physician’s choice non-CDK4/6 standard systemic therapy.

ClinicalTrials.gov ID: NCT07227233

A Phase II Multi-Center Open-label Randomized Study of CAPecitabine in Combination With ELAcestrant Versus Capecitabine Alone in Advanced Estrogen Receptor-Positive Breast Cancer (CAPELA)

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.

TrialFetch AI summary: Adults (women or men) with ER-positive (≥10%), HER2-negative metastatic or unresectable locally recurrent breast cancer, ECOG 0–1, measurable/evaluable disease, known ESR1 mutation status, and progression after prior CDK4/6 inhibitor–based endocrine therapy (no prior chemotherapy for metastatic disease; prior fulvestrant allowed). Patients are randomized to capecitabine alone versus capecitabine plus elacestrant (an oral selective estrogen receptor degrader that binds and promotes degradation of ER to inhibit ER signaling), with an optional switch to elacestrant monotherapy at progression for ESR1-mutant patients initially assigned to capecitabine.

ClinicalTrials.gov ID: NCT07222215

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.

TrialFetch 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

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

TrialFetch 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

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.

TrialFetch 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

Phase II Trial of Photon Craniospinal Irradiation for Leptomeningeal Disease Secondary to Solid Tumor Malignancy

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 leptomeningeal disease secondary to breast cancer or non-small cell lung cancer who have adequate performance status and organ function, and treats them with photon craniospinal irradiation using VMAT, an advanced conformal radiation therapy technique. All patients receive 10 fractions of CSI over 10 to 20 days to assess efficacy and safety in controlling central nervous system progression.

ClinicalTrials.gov ID: NCT06910761

Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated 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 recurrent or second primary tumors in body sites previously treated with radiotherapy—including CNS, head and neck, breast, thoracic, GI, GU, and gynecological cancers—to evaluate reirradiation using pencil beam scanning proton therapy, which aims to provide effective tumor control with reduced toxicity compared to standard photon techniques. No investigational drugs are included, and some cohorts may not allow concurrent chemotherapy.

ClinicalTrials.gov ID: NCT05313191

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