Clinical Trials for Breast Cancer

DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain 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: Adults with HER2-negative metastatic breast cancer and ECOG 0–2 are eligible if they have ER-positive brain metastases after endocrine therapy, triple-negative brain metastases, or leptomeningeal disease of any ER status. All receive datopotamab deruxtecan, a TROP2-directed antibody–drug conjugate that delivers a topoisomerase I inhibitor, every 21 days; there is no comparator arm.

ClinicalTrials.gov ID: NCT06176261

A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)

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 previously untreated unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer and a germline BRCA1, BRCA2, or PALB2 loss-of-function mutation are randomized to saruparib, a selective PARP1 inhibitor, plus camizestrant, an estrogen-receptor degrader; physician-selected CDK4/6 inhibition plus standard endocrine therapy; or CDK4/6 inhibition plus camizestrant.

ClinicalTrials.gov ID: NCT06380751

A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)

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 previously untreated, unresectable locally recurrent or metastatic triple-negative breast cancer and PD-L1 CPS <10 are randomized to sacituzumab tirumotecan alone, sacituzumab tirumotecan plus pembrolizumab, or physician’s-choice chemotherapy. Sacituzumab tirumotecan is an investigational TROP2-directed antibody–drug conjugate that delivers a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT06841354

An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator's Choice of Therapy in Adult Participants With Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based 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 HR-positive, HER2-negative unresectable locally advanced or metastatic breast cancer progressing after CDK4/6 inhibitor–based therapy are randomized to PF-07248144 plus fulvestrant or everolimus plus investigator-selected exemestane or fulvestrant. PF-07248144 is an investigational KAT6A/KAT6B inhibitor; patients with detectable PIK3CA, AKT1, or PTEN alterations or prior chemotherapy or antibody–drug conjugates for advanced disease are excluded.

ClinicalTrials.gov ID: NCT07062965

A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor

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 PIK3CA-mutant, HR-positive/HER2-negative unresectable locally advanced or metastatic breast cancer who progressed after endocrine therapy and one prior CDK4/6 inhibitor are randomized to zovegalisib (RLY-2608), an investigational mutant-selective allosteric PI3Kα inhibitor, plus fulvestrant or capivasertib, an AKT inhibitor, plus fulvestrant.

ClinicalTrials.gov ID: NCT06982521

An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)

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 HR-positive, HER2-negative unresectable locally advanced or metastatic breast cancer progressing after CDK4/6 inhibitor plus endocrine therapy, or recurring during or within 24 months of adjuvant CDK4/6 inhibitor therapy, are randomized to patritumab deruxtecan or physician’s choice of chemotherapy or trastuzumab deruxtecan. Patritumab deruxtecan is a HER3-targeted antibody–drug conjugate that delivers a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT07060807

A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease

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 previously untreated, inoperable locally recurrent or metastatic PD-L1–negative TNBC or ER-low (1%–10%), HER2-negative breast cancer who are ineligible for standard PD-(L)1 therapy, this trial compares physician’s-choice chemotherapy plus pumitamig with chemotherapy plus placebo. Pumitamig is an investigational bispecific antibody targeting PD-L1 and VEGF-A.

ClinicalTrials.gov ID: NCT07173751

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

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 PIK3CA-mutant, HR-positive/HER2-negative unresectable locally advanced or metastatic breast cancer are eligible; the randomized comparison requires no prior systemic therapy for advanced disease, while a dose-finding part allows up to two prior regimens. LY4064809 (tersolisib), an oral allosteric inhibitor preferentially targeting mutant PI3Kα, is added to a CDK4/6 inhibitor and endocrine therapy; the randomized comparison uses palbociclib plus an aromatase inhibitor or fulvestrant with LY4064809 versus placebo.

ClinicalTrials.gov ID: NCT07174336

A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)

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 ER-positive, HER2-negative locally advanced or metastatic breast cancer who have received no systemic therapy for advanced disease are randomized to first-line palazestrant plus ribociclib or letrozole plus ribociclib. Palazestrant is an oral estrogen receptor–targeting agent designed to inhibit AF1 and AF2 transcriptional activity and promote receptor degradation.

ClinicalTrials.gov ID: NCT07085767

SERAFA-1: A Single Arm, Open Label, Multicentre, Phase IIIb Study Of Camizestrant Plus Ribociclib in 1st Line Treatment of ER Positive, HER2-negative Advanced Breast Cancer Patients

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: This single-arm study enrolls adults with unresectable recurrent or metastatic ER-positive, HER2-negative breast cancer who have received no systemic therapy for advanced disease. All receive first-line oral camizestrant, an estrogen-receptor degrader, plus ribociclib, a CDK4/6 inhibitor.

ClinicalTrials.gov ID: NCT07647328