Clinical Trials for Breast Cancer

HARMONY: Harnessing the Analysis of RNA Expression and Molecular Subtype to Optimize Novel TherapY for Metastatic Breast Cancer

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.

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.

HealthScout AI summary: Adults with metastatic breast cancer (up to one prior line of metastatic therapy) are eligible to have their tumor tissue analyzed using PAM50 RNA-based molecular subtyping, with results shared with their treating oncologist to inform and potentially change treatment planning; no investigational drugs are administered.

ClinicalTrials.gov ID: NCT03769415

A First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, As a Single Agent in Advanced Solid Tumor Patients and in Combination with Fulvestrant in Patients with Advanced 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.

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic PIK3CA-mutated solid tumors—including HR+ HER2- breast cancer and endometrial cancer—to receive the mutant-selective PI3Kα inhibitor RLY-2608 (oral, allosteric, isoform- and mutant-specific) as monotherapy or in combination with fulvestrant, CDK4/6 inhibitors, or the investigational CDK4-only inhibitor PF-07220060. Eligible patients include those who are refractory or intolerant to standard therapies, including prior endocrine and CDK4/6 inhibitor treatments.

ClinicalTrials.gov ID: NCT05216432

Phase 2 Single Arm Trial With a Safety Lead-in of Tucatinib in Combination With Doxil for the Treatment of HER2+ Metastatic Breast Cancer

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 HER2-positive locally advanced or metastatic breast cancer and measurable disease who have received prior anti-HER2 therapy, excluding those with prior anthracycline use or significant cardiac issues. Patients receive tucatinib, a selective HER2 tyrosine kinase inhibitor, in combination with Doxil (pegylated liposomal doxorubicin).

ClinicalTrials.gov ID: NCT05748834

An Open-Label, Phase 1/2 Study of ORIC-114 As a Single Agent or in Combination with Chemotherapy, in Patients with Advanced Solid Tumors Harboring an EGFR or HER2 Alteration

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.

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.

HealthScout AI summary: Eligible patients have advanced or metastatic solid tumors (including NSCLC and breast cancer) with EGFR exon 20 insertions, atypical EGFR mutations, HER2 exon 20 insertions, or HER2 amplification/overexpression, who have progressed after standard therapies or are unsuitable for them. The trial evaluates ORIC-114, an oral, CNS-penetrant, irreversible EGFR/HER2 inhibitor, as monotherapy or combined with carboplatin/pemetrexed chemotherapy.

ClinicalTrials.gov ID: NCT05315700

Phase 1 Pilot Study With Dose Expansion of Chemotherapy in Combination With CD40 Agonist and Flt3 Ligand in Metastatic HER2 Negative 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.

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.

HealthScout AI summary: This trial enrolls adults with unresectable stage III or IV HER2 negative metastatic breast cancer (including both triple negative and hormone receptor positive disease) who have progressed after prior therapy, testing the combination of pegylated liposomal doxorubicin with the CD40 agonist antibody CDX-1140 and the Flt3 ligand CDX-301 (a dendritic cell growth factor) to evaluate safety and early efficacy. All participants ultimately receive all three agents, with sequencing varying by cohort.

ClinicalTrials.gov ID: NCT05029999

VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer

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 whose disease progressed during or within 12 months of (neo)adjuvant endocrine therapy and who have not received prior systemic therapy for advanced disease; participants are randomized to receive standard fulvestrant plus a CDK4/6 inhibitor with or without gedatolisib, an investigational pan-PI3K/mTOR inhibitor that targets key resistance pathways.

ClinicalTrials.gov ID: NCT06757634

Phase II Study of Estradiol Therapy to Target ER-Mutant and ER-Wild-Type ER+ Metastatic or Advanced Breast Cancer

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 post-menopausal women with incurable, ER-positive metastatic or recurrent breast cancer who have progressed on at least one prior endocrine therapy, and treats them with oral 17b-estradiol (an estrogen receptor agonist) monotherapy to evaluate benefit, including in patients with tumors harboring ESR1 mutations. Concurrent anti-cancer therapies are not allowed except trastuzumab for HER2-positive disease and anti-resorptive agents.

ClinicalTrials.gov ID: NCT05716516

A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy (LITESPARK-029)

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 ER-positive, HER2-negative unresectable or metastatic breast cancer that has progressed after prior endocrine therapy (including a CDK4/6 inhibitor), randomizing them to the HIF-2α inhibitor belzutifan plus fulvestrant versus the standard-of-care everolimus plus endocrine therapy. Belzutifan targets hypoxia-induced pathways and has a safety profile notable for anemia and hypoxia.

ClinicalTrials.gov ID: NCT06428396

A Phase 1, First-in-human, Dose Escalation and Expansion, Multicenter Study of XMT-1660 in Participants With 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.

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.

HealthScout AI summary: Adults with advanced, recurrent, or metastatic solid tumors (including breast, endometrial, and ovarian cancers) who have progressed on standard therapy and meet eligibility criteria are treated with XMT-1660, a B7-H4-targeted antibody-drug conjugate delivering an auristatin payload to B7-H4-positive tumor cells. Prior B7-H4 therapy or auristatin ADCs, untreated CNS metastases, and significant comorbidities are excluded.

ClinicalTrials.gov ID: NCT05377996

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

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 PIK3CA-mutated, HER2-positive locally advanced or metastatic breast cancer after first-line taxane plus Phesgo induction, randomizing them to maintenance with inavolisib (an oral PI3Kα inhibitor) plus Phesgo versus placebo plus Phesgo. Prior PI3K inhibitor use and significant comorbidities are excluded.

ClinicalTrials.gov ID: NCT05894239