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.

HealthScout AI summary: This trial enrolls adults with ER+, HER2- advanced or metastatic breast cancer who have progressed on 1–2 lines of endocrine therapy (including a CDK4/6 inhibitor) and randomizes them to receive either palazestrant (OP-1250), an oral complete estrogen receptor antagonist (CERAN) and degradant, or standard endocrine therapy (fulvestrant or aromatase inhibitor). Key exclusions include symptomatic visceral disease, prior chemotherapy for advanced/metastatic disease, and active CNS involvement.

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.

HealthScout AI summary: This trial enrolls adult patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer who have developed resistance to prior adjuvant endocrine therapy, with no prior systemic treatment for advanced disease. Patients are randomized to receive either fulvestrant (IM SERD) or giredestrant (oral selective estrogen receptor degrader targeting both wild-type and mutant ER), each combined with a CDK4/6 inhibitor of the investigator's choice.

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.

HealthScout AI summary: Eligible patients are adults with HR-positive, HER2-negative, locally advanced or metastatic breast cancer who have not received prior systemic therapy for advanced disease. This trial compares PF-07220060, a selective oral CDK4 inhibitor plus letrozole, with standard first-line CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) plus letrozole.

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic breast cancer (including triple-negative and HR+/HER2- subtypes) who are ineligible for further anthracyclines, taxanes, PD-1, or PARP inhibitor therapies, and have received prior chemotherapy. Patients are randomized to standard capecitabine or to regimens combining capecitabine with PCS6422, an investigational oral inhibitor of dihydropyrimidine dehydrogenase (DPD) designed to increase 5-FU exposure and potentially enhance anti-tumor activity.

ClinicalTrials.gov ID: NCT06568692

Phase 2 Study of Paclitaxel (NSC #673089) + Ipatasertib (NSC #781451) in Taxane-Refractory Participants With PTEN/AKT-Altered Advanced Non-Breast Solid Tumors: A ComboMATCH Treatment Trial

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.

HealthScout AI summary: Eligible patients are adults with advanced or metastatic non-breast solid tumors harboring activating PTEN or AKT alterations who have progressed on or within 6 months of taxane-based therapy and have not received prior AKT inhibitors. Participants receive paclitaxel plus ipatasertib, an oral selective pan-AKT inhibitor, until progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT05554380

A Phase II, Multi-site, Randomized, Open-label Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT327 at Two Dose Levels in Combination With Chemotherapeutic Agents as First- and Second-line Treatment in Triple-negative 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.

HealthScout AI summary: This trial enrolls adults with locally advanced or metastatic triple-negative breast cancer, either treatment-naïve in the metastatic setting or with one prior line of therapy, to receive BNT327 (a bispecific antibody targeting PD-L1 and VEGF-A) in combination with standard chemotherapy agents (nab-paclitaxel, paclitaxel, gemcitabine/carboplatin, or eribulin) as first- or second-line treatment. Patients must have ECOG 0-1, measurable disease, and no significant autoimmune or comorbid conditions.

ClinicalTrials.gov ID: NCT06449222

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.

HealthScout AI summary: This trial enrolls patients with PD-L1 positive (CPS ≥10) locally recurrent inoperable or metastatic triple-negative breast cancer, who have not received prior systemic therapy for advanced disease, to compare datopotamab deruxtecan (a TROP2-directed antibody-drug conjugate) with or without durvalumab (a PD-L1 inhibitor) versus investigator’s choice of chemotherapy plus pembrolizumab.

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.

HealthScout AI summary: This trial enrolls adult patients with advanced or metastatic breast cancer who have failed all standard subtype-appropriate therapies and have no remaining approved treatment options, including those with stable brain metastases. Patients are randomized to receive either physician's choice of chemotherapy or the investigational regimen of Bria-IMT (an allogeneic GM-CSF-secreting irradiated breast cancer cell line designed to stimulate anti-tumor immunity) plus low-dose cyclophosphamide, intradermal interferon-alpha, and the PD-1 inhibitor retifanlimab.

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.

HealthScout AI summary: This trial enrolls adults with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have progressed on at least one prior endocrine therapy (including a CDK4/6 inhibitor), randomizing them to sacituzumab tirumotecan (a TROP2-directed antibody-drug conjugate), sacituzumab tirumotecan plus pembrolizumab (anti-PD-1), or physician’s choice of standard single-agent chemotherapy. Key exclusions include prior chemotherapy for metastatic disease and active autoimmune conditions.

ClinicalTrials.gov ID: NCT06312176

Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor 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.

HealthScout AI summary: This trial enrolls adults with HR-positive, HER2-negative advanced or metastatic breast cancer who have progressed on prior CDK4/6 inhibitor plus non-steroidal aromatase inhibitor therapy, excluding those with prior PI3K/AKT/mTOR inhibitor or chemotherapy for advanced disease. Patients are randomized to gedatolisib (a pan-PI3K/mTOR inhibitor) plus fulvestrant with or without palbociclib versus standard-of-care options (fulvestrant alone or alpelisib plus fulvestrant, depending on PIK3CA mutation status).

ClinicalTrials.gov ID: NCT05501886