Clinical Trials for Breast Cancer

A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors

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 advanced solid tumors may receive the oral selective CDK2 inhibitor BG-68501 alone; expansion cohorts focus on HR-positive/HER2-negative breast cancer and platinum-resistant or -refractory serous ovarian, fallopian tube, or primary peritoneal cancer. Breast cancer cohorts also evaluate BG-68501 with fulvestrant, with or without the investigational selective CDK4 inhibitor BGB-43395.

ClinicalTrials.gov ID: NCT06257264

A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors

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, advanced or unresectable TP53-mutated or TP53-loss triple-negative breast cancer, platinum-resistant high-grade serous ovarian, primary peritoneal or fallopian-tube cancer, or recurrent serous endometrial cancer receive oral AO-252 monotherapy. AO-252 is an investigational inhibitor of TACC3 protein–protein interactions.

ClinicalTrials.gov ID: NCT06136884

A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative and Gastrin Releasing Peptide Receptor Positive Advanced Breast Cancer Experiencing Early Relapse From (Neo)Adjuvant Endocrine Therapy or Who Have Progressed on Endocrine Therapy in Combination With a CDK4/6 Inhibitor for Advanced Disease

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 ER-positive, HER2-negative unresectable or metastatic breast cancer and GRPR-positive disease on [68Ga]Ga-NeoB PET may be eligible after early relapse on (neo)adjuvant endocrine therapy or progression after one endocrine-therapy line for advanced disease. Treatment combines dose-escalated [177Lu]Lu-NeoB, a GRPR-targeted radioligand that delivers lutetium-177 radiation, with ribociclib and fulvestrant.

ClinicalTrials.gov ID: NCT05870579

A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies

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 advanced, incurable non-CNS solid tumors after progression on or intolerance to systemic therapy receive oral ETX-19477, an investigational PARG inhibitor that disrupts DNA damage repair. Enrollment preferentially considers tumors with loss-of-function BRCA2 mutations; treatment is given as monotherapy in dose-escalation and expansion cohorts.

ClinicalTrials.gov ID: NCT06395519

A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Cyclin A/B-RxL Inhibitor CID-078 in Patients With Advanced Solid Tumor Malignancies

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 trial evaluates oral CID-078 monotherapy, an inhibitor of the RxL-binding sites of cyclins A and B, in patients with advanced solid tumors that have progressed after available treatment. Expansion cohorts include patients with triple-negative breast cancer, relapsed or refractory small-cell lung cancer, or RB1-altered/Rb-loss-of-function solid tumors.

ClinicalTrials.gov ID: NCT06577987

ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies

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: Patients with metastatic HER2-positive breast cancer progressing after trastuzumab deruxtecan receive trastuzumab plus physician-selected chemotherapy with or without evorpacept, an investigational CD47 blocker that promotes macrophage engulfment of cancer cells. A separate substudy combines evorpacept with cetuximab and FOLFIRI for left-sided, microsatellite-stable, RAS/BRAF wild-type metastatic colorectal cancer progressing after first-line oxaliplatin, with no prior anti-EGFR therapy or irinotecan.

ClinicalTrials.gov ID: NCT07007559

Study to Assess the Safety and Efficacy of Evexomostat (SDX-7320) in Combination With A PI3K or Akt Inhibitor Plus Fulvestrant in Patients With HR+, HER2-, Metastatic Breast Cancer With PI3K Pathway Alteration(s)

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: This trial enrolls men and postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancer harboring a PIK3CA mutation, PTEN loss, or AKT1 mutation after progression on endocrine therapy and a CDK4/6 inhibitor. Patients receive fulvestrant and investigational evexomostat, a polymer–drug conjugate that releases a METAP2 inhibitor, plus either the PI3Kα inhibitor alpelisib or the AKT inhibitor capivasertib.

ClinicalTrials.gov ID: NCT05455619

A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors

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: Women with progressing advanced or metastatic ER-positive/HER2-negative breast cancer previously treated with a CDK4/6 inhibitor, or platinum-treated metastatic high-grade serous ovarian cancer, may receive AZD8421, an investigational selective CDK2 inhibitor, as monotherapy. In the breast cancer cohorts, AZD8421 is also studied with camizestrant and palbociclib, abemaciclib, or ribociclib.

ClinicalTrials.gov ID: NCT06188520

A First-in-Human, Open-Label, Dose Escalation and Expansion Trial of BTX-9341 in Participants With Advanced and/or Metastatic Breast Cancer

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 trial enrolls patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer previously treated with a CDK4/6 inhibitor, with no more than one prior chemotherapy regimen for advanced disease. It evaluates oral BTX-9341, a cereblon-directed CDK4/6 degrader, alone or with fulvestrant; patients with RB1 mutations or current or prior CNS metastases are excluded.

ClinicalTrials.gov ID: NCT06515470

A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4/6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, or With the mTOR Inhibitor Everolimus in Adult Subjects With Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

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 ER-positive, HER2-negative advanced or metastatic breast cancer and ECOG performance status 0–1 receive investigational palazestrant, an estrogen receptor antagonist that also promotes receptor degradation, combined with ribociclib (CDK4/6 inhibitor), alpelisib (PI3K inhibitor), or everolimus (mTOR inhibitor). Prior hormonal therapy is limited to one regimen for the ribociclib group and two for the alpelisib and everolimus groups.

ClinicalTrials.gov ID: NCT05508906