Clinical Trials for Breast Cancer

A Two-part, Seamless, Multicenter, Randomized, Open-label, Adaptive Phase II/III Study of the Blood-brain Barrier Penetrant RO7771950 Versus Tucatinib, Both in Combination With Trastuzumab and Capecitabine, in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2-Positive Breast Cancer, With or Without Central Nervous System Metastases

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: Patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer, with or without CNS metastases (including leptomeningeal disease), are eligible if they have received prior metastatic anti-HER2 therapy and are TKI-naïve in the advanced setting. They are randomized to the blood-brain barrier–penetrant HER2 tyrosine kinase inhibitor RO7771950 or tucatinib, each combined with trastuzumab and capecitabine.

ClinicalTrials.gov ID: NCT07413939

Overcoming PARP Inhibitor Resistance in BRCA Germline Mutation Positive Advanced 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.

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: Women with HER2-negative, germline BRCA-mutated advanced or metastatic breast cancer who have progressed after at least two months of PARP inhibitor therapy are randomized to olaparib plus cediranib, a VEGFR1–3 inhibitor, or olaparib plus ceralasertib, an ATR inhibitor.

ClinicalTrials.gov ID: NCT04090567

A Phase 1b/2 Open-Label Study of Disitamab Vedotin in Combination With Other Anticancer Therapies in Solid Tumors

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

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: Adults with HER2-low or HER2-positive unresectable or metastatic breast cancer or gastric/gastroesophageal junction adenocarcinoma, generally after relevant standard therapy, receive disitamab vedotin plus tucatinib. Disitamab vedotin is an investigational HER2-directed antibody–drug conjugate that delivers the microtubule inhibitor MMAE; tucatinib is a HER2-targeted tyrosine kinase inhibitor.

ClinicalTrials.gov ID: NCT06157892

A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

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

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: Adults with previously treated, progressive recurrent or metastatic solid tumors across 13 cohorts receive intravenous ifinatamab deruxtecan, generally every 3 weeks. This investigational antibody–drug conjugate targets B7-H3 (CD276) and delivers a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06330064

"A Phase 2, Double Blinded, Randomized Controlled Trial of Evexomostat (SDX-7320) or Placebo in Combination With Eribulin for Patients With Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study

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.

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 advanced or metastatic triple-negative breast cancer and metabolic dysfunction (HbA1c >5.5% and/or BMI ≥30 kg/m²) who have received no more than two prior lines of therapy for advanced disease receive eribulin plus evexomostat or placebo. Evexomostat is an investigational polymer–drug conjugate that releases a methionine aminopeptidase 2 (METAP2) inhibitor.

ClinicalTrials.gov ID: NCT05570253

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

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

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: Adults with ECOG 0–1 and previously treated, refractory, locally advanced unresectable or metastatic solid tumors across multiple tumor-specific cohorts receive patritumab deruxtecan 5.6 mg/kg IV every 3 weeks. This investigational HER3-targeted antibody–drug conjugate delivers an exatecan-derived topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06172478

A Phase 2 Master Protocol to Assess the Efficacy and Safety of FORE8394, an Inhibitor of BRAF Class 1 and Class 2 Alterations, in Participants With Cancer Harboring BRAF Alterations

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.

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: Patients aged ≥10 years with advanced solid tumors or recurrent or progressive primary CNS tumors harboring eligible BRAF fusions or BRAF V600E mutations receive plixorafenib, an oral inhibitor of BRAF V600 signaling and BRAF-containing dimers. Depending on the tumor cohort, plixorafenib is given alone or with cobicistat to increase plixorafenib exposure; patients with metastatic cutaneous melanoma or thyroid cancer are randomized between these regimens.

ClinicalTrials.gov ID: NCT05503797

A Phase IIIb, Open-label, Multinational Study Assessing the Efficacy and Safety of Dato-DXd Treatment in Patients With HRpositive, HER2 IHC 0, Locally Advanced Inoperable or Metastatic Breast Cancer Refractory to Endocrine Therapy (TROPION-Breast06)

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

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 single-arm study enrolls adults with endocrine-refractory, HR-positive, HER2 IHC 0 inoperable locally advanced or metastatic breast cancer who have not received chemotherapy for metastatic disease. Patients receive datopotamab deruxtecan, a TROP2-directed antibody–drug conjugate that delivers a topoisomerase I inhibitor, before chemotherapy.

ClinicalTrials.gov ID: NCT07205822

A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)

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

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: For patients with ER-positive, HER2-negative advanced or recurrent breast cancer that has progressed after systemic therapy, with prior CDK4/6-inhibitor exposure and ECOG performance status 0–1, this single-arm study evaluates camizestrant, an oral estrogen-receptor degrader, plus atirmociclib, an oral selective CDK4 inhibitor. Patients receive a single atirmociclib dose before starting the combination.

ClinicalTrials.gov ID: NCT07427394

Phase 2 Trial With a Safety Run-in of Combinatorial Therapies With Intrathecal (IT) Dendritic Cell Vaccines (cDC1s) inHER+ (Combined With IT Trastuzumab) and HER2- (Combined With IT Nivolumab) Breast Cancer (BC) Leptomeningeal Disease (LMD)

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

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: Adults with HER2-positive or HER2-negative breast cancer and confirmed leptomeningeal disease receive an intrathecal autologous cDC1 vaccine designed to induce HER2/HER3-specific T-cell responses. HER2-positive patients also receive intrathecal trastuzumab (HER2-targeted), while HER2-negative patients receive intrathecal nivolumab (PD-1 blockade).

ClinicalTrials.gov ID: NCT07694986