Clinical Trials for Breast Cancer

A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with ER-positive, HER2-negative advanced or metastatic breast cancer that has progressed after endocrine therapy plus a CDK4/6 inhibitor, with no prior chemotherapy for advanced disease, are randomized to oral palazestrant or investigator’s choice of fulvestrant or an aromatase inhibitor. Palazestrant targets the estrogen receptor by inhibiting AF1/AF2 transcriptional activation and promoting receptor degradation.

ClinicalTrials.gov ID: NCT06016738

A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: For patients with incurable locally advanced or metastatic ER-positive, HER2-negative breast cancer who relapse during or within 12 months after adjuvant endocrine therapy and have received no systemic treatment for advanced disease. Patients receive giredestrant, an investigational oral selective estrogen receptor degrader, or fulvestrant, each combined with a CDK4/6 inhibitor; efficacy is assessed overall and by ESR1 mutation status.

ClinicalTrials.gov ID: NCT06065748

AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO CDK4/6 INHIBITOR PLUS LETROZOLE IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTICANCER TREATMENT FOR ADVANCED/METASTATIC DISEASE (FOURLIGHT-3)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with HR-positive, HER2-negative unresectable locally advanced or metastatic breast cancer and no prior systemic therapy for advanced disease are randomized to atirmociclib, a selective CDK4 inhibitor, plus letrozole or investigator-selected palbociclib, ribociclib, or abemaciclib plus letrozole. Patients with visceral crisis or current or prior CNS metastases are excluded.

ClinicalTrials.gov ID: NCT06760637

A Phase 2, Open-Label Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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 unresectable advanced or metastatic triple-negative or HR-positive/HER2-negative breast cancer, measurable disease, and ECOG 0–1 are randomized to low-dose capecitabine plus PCS6422 (eniluracil) or standard-dose capecitabine. PCS6422 irreversibly inhibits DPD, reducing breakdown of the 5-fluorouracil generated from capecitabine.

ClinicalTrials.gov ID: NCT06568692

A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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: For patients with PD-L1–positive (CPS ≥10), inoperable locally recurrent or metastatic triple-negative breast cancer who have received no systemic therapy for advanced disease, this trial compares datopotamab deruxtecan (Dato-DXd) plus durvalumab, Dato-DXd alone, and chemotherapy plus pembrolizumab. Dato-DXd is a TROP2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor; durvalumab and pembrolizumab are immune checkpoint inhibitors.

ClinicalTrials.gov ID: NCT06103864

Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer.

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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 unresectable locally recurrent or metastatic breast cancer and no meaningful remaining approved treatment options are randomized to Bria-IMT plus the PD-1 inhibitor retifanlimab or physician’s-choice chemotherapy; an initial cohort also receives Bria-IMT alone. Bria-IMT combines low-dose cyclophosphamide, an investigational GM-CSF–secreting breast cancer cell vaccine, and injection-site interferon to stimulate antitumor immunity.

ClinicalTrials.gov ID: NCT06072612

An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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: For patients with HR+/HER2− unresectable locally advanced or metastatic breast cancer that progressed after endocrine therapy including a CDK4/6 inhibitor, and who have not received chemotherapy for advanced disease, this trial compares sacituzumab tirumotecan alone or with pembrolizumab against physician’s-choice chemotherapy. Sacituzumab tirumotecan is a TROP2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor; pembrolizumab inhibits PD-1.

ClinicalTrials.gov ID: NCT06312176

A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or Trastuzumab Deruxtecan (T-DXd) in Patients With Metastatic HER2-negative (HER2-low or HER2-0) Breast Cancer After Progression on Prior Antibody Drug Conjugate Therapy

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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 unresectable locally advanced or metastatic HER2-low or HER2-0 breast cancer, including hormone receptor–positive and –negative disease, receive trastuzumab deruxtecan (HER2-directed) or datopotamab deruxtecan (TROP2-directed), both antibody–drug conjugates carrying topoisomerase I inhibitors. Eligible patients may receive the other agent after progression, including those who enter having already progressed on one of the two drugs.

ClinicalTrials.gov ID: NCT06533826

A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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: For adults with HR-positive, HER2-negative recurrent or metastatic breast cancer that has progressed after at least two endocrine therapy lines and prior CDK4/6 inhibitor therapy; prior chemotherapy for metastatic disease is not allowed. Patients receive one of three doses of alisertib, an investigational oral Aurora A kinase inhibitor, with endocrine therapy.

ClinicalTrials.gov ID: NCT06369285

A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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 unresectable or metastatic solid tumors other than NSCLC that harbor an activating HER2 mutation are eligible after appropriate standard therapy or when no satisfactory alternative exists; prior HER2 tyrosine kinase inhibitor treatment and active brain metastases are excluded. All participants receive oral sevabertinib, a reversible HER2-directed tyrosine kinase inhibitor, 20 mg twice daily.

ClinicalTrials.gov ID: NCT06760819