Clinical Trials for Breast Cancer

Prevention of Datopotamab Deruxtecan (TROP-2 Directed ADC) Associated Stomatitis in Patients With HER2-negative Metastatic Breast Cancer or Non-small Cell Lung Cancer Using Dexamethasone Mouthwash: a Single-arm, Phase 2 Trial (TROPION- DM, 2023-ESR-000087)

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 advanced/metastatic HER2-negative breast cancer (TNBC or HR+/HER2− post-CDK4/6 and chemo/ADC) or previously treated non-squamous NSCLC receive datopotamab deruxtecan (TROP2-directed ADC delivering a topoisomerase I inhibitor) plus prophylactic dexamethasone mouthwash. The study assesses whether short-course steroid mouthwash during the first three cycles reduces Dato-DXd–associated stomatitis while patients continue Dato-DXd q3w.

ClinicalTrials.gov ID: NCT06974604

An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline/TESARO-Sponsored Niraparib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Niraparib

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to 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: Single-arm extension providing continued niraparib to adults who completed a prior GSK/TESARO niraparib study and are still benefiting, with controlled toxicities and ongoing dosing from the parent protocol. Niraparib is an oral PARP-1/2 inhibitor exploiting synthetic lethality (e.g., HRD/BRCA-mutated tumors); treatment continues until progression/toxicity with focus on long-term safety monitoring.

ClinicalTrials.gov ID: NCT04641247

Randomized Phase II Study of Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor (Palbociclib, Abemaciclib, or Ribociclib) in Patients With ER+/HER2- Advanced or Metastatic Breast Cancer With Prior Exposure to a CKD4/6 Inhibitor

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 ER+/HER2− advanced or metastatic breast cancer harboring an ESR1 mutation, ECOG 0–1, previously treated with a CDK4/6 inhibitor and at least two prior endocrine therapies, are randomized to elacestrant (oral SERD) alone versus elacestrant plus a CDK4/6 inhibitor (palbociclib, abemaciclib, or ribociclib). Aims to test whether adding CDK4/6 blockade to elacestrant improves PFS in this post–CDK4/6–exposed, endocrine-resistant population.

ClinicalTrials.gov ID: NCT06062498

Single Arm Pilot Trial of Adaptive Therapy (AT) With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, Hormone Refractory 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 ER-positive, HER2-negative metastatic breast cancer refractory to endocrine therapy (no prior chemo/ADCs for MBC, ECOG 0–2) receive oral capecitabine, starting with two standard cycles followed by an adaptive dosing strategy guided by serial imaging and blood-based tumor burden to modulate dose up or down. Capecitabine is a fluoropyrimidine prodrug converted to 5-FU that inhibits thymidylate synthase and is standard in this setting; exclusions include visceral crisis, uncontrolled brain mets, and complete DPD deficiency.

ClinicalTrials.gov ID: NCT06525766

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