Gedatolisib Combination for Breast Cancer

Recruiting at 243 trial locations

Overseen By Nadene Zack, MS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Celcuity Inc

Must be taking: LHRH agonists

Must not be taking: PI3K inhibitors, Akt inhibitors

Disqualifiers: Type 1 diabetes, Brain metastases, Cardiovascular abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 months

674 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of drugs for a specific type of advanced breast cancer, known as HR+/HER2-. The researchers aim to determine if combining gedatolisib (an experimental treatment) with other drugs is effective and safe for patients whose cancer has progressed despite previous treatments. Participants will receive either this new combination or a standard treatment for comparison. Those with HR+/HER2- breast cancer that worsened within a year of hormone therapy might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that pre-menopausal women must continue treatment with an LHRH agonist during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining gedatolisib with palbociclib and hormone therapy has been tested in previous studies. These studies identified some side effects, with the most common serious ones being a low white blood cell count in 61% of patients, skin rash in 39%, and mouth sores in 29%. However, the safety profile of this combination was similar to that of palbociclib with letrozole, indicating it is manageable.

For those considering joining a clinical trial, these findings suggest that while side effects exist, they are known and somewhat typical for such treatments. Discussing these potential side effects with healthcare professionals is important to understand the implications and decide if joining the trial is the right choice. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard breast cancer treatments that mainly focus on blocking hormones or slowing cell division, gedatolisib stands out because it targets the PI3K/mTOR pathway, which plays a crucial role in cancer cell growth and survival. This unique mechanism has the potential to enhance the effectiveness of existing treatments like Palbociclib or Ribociclib by addressing different aspects of cancer cell behavior. Researchers are particularly excited about gedatolisib because it could offer a more comprehensive approach to treatment, potentially leading to better outcomes for patients with advanced breast cancer.

What evidence suggests that this trial's treatments could be effective for breast cancer?

This trial will evaluate the effectiveness of two treatment combinations for advanced HR+/HER2- breast cancer. In Arm A, participants will receive Gedatolisib with either Palbociclib or Ribociclib, along with Fulvestrant. Studies have shown that this combination can significantly improve progression-free survival, allowing patients longer periods without their cancer worsening. In one study, 85% of patients responded well to the treatment, suggesting the combination is promising for those with advanced breast cancer, potentially offering more time without disease progression. Arm B will evaluate the effectiveness of Palbociclib or Ribociclib with Fulvestrant alone. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with HR+/HER2- advanced breast cancer that's spread or can't be removed by surgery. It includes both men and women, but pre-menopausal women must use LHRH agonists. Participants need measurable disease, an ECOG status of 0-2, and no recent progression on similar treatments.

Inclusion Criteria

My cancer got worse during or within a year after hormone therapy.

I can provide a sample for PIK3CA mutation testing.

I have received chemotherapy before or after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Run-in

Determine the gedatolisib dose with ribociclib

4 weeks

Treatment

Participants receive gedatolisib with fulvestrant and ribociclib or palbociclib, or standard-of-care control

48 months

Weekly visits for gedatolisib administration, monthly visits for palbociclib or ribociclib

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Gedatolisib
• Palbociclib or Ribociclib

Trial Overview The study compares Gedatolisib combined with Fulvestrant and CDK4/6 Inhibitors (Palbociclib or Ribociclib) against just Palbociclib/Ribociclib with Fulvestrant in patients. The goal is to see if adding Gedatolisib improves treatment outcomes.

How Is the Trial Designed?

Group I: Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant Experimental Treatment 2 Interventions

Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off

Group II: Arm B: Palbociclib or Ribociclib + Fulvestrant Active Control 2 Interventions

Drug: Palbociclib Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle

Who Is Running the Clinical Trial?

Celcuity Inc

Lead Sponsor

Trials

9

Recruited

1,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06757634

NCT06757634 | Phase 3 Study of Gedatolisib as First-Line ... This is a Phase 3, open-label, randomized clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant combined with a CDK4/6 inhibitor ...

2. cancernetwork.com cancernetwork.com/view/pam-inhibition-adds-value-in-hr-her2--pik3ca-wild-type-advanced-breast-cancer

PAM Inhibition Adds Value in HR+/HER2- PIK3CA Wild ... Gedatolisib enhanced PFS in advanced breast cancer, showcasing significant benefits when combined with fulvestrant and palbociclib.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40711480/

Gedatolisib Combined with Palbociclib and Letrozole in ... Results: Of 41 patients, all had stage IV disease, 93% had measurable disease, 78% had visceral metastases, and 22% had detectable PIK3CA ...

4. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00034-2/abstract

Gedatolisib in combination with palbociclib and endocrine ... Gedatolisib, palbociclib, and endocrine therapy induced an objective response in 23 (85·2%; 90% CI 69·2–94·8) of 27 evaluable first-line participants (group A).

5. targetedonc.com targetedonc.com/view/gedatolisib-shows-impressive-pfs-in-hr-her2-breast-cancer

Gedatolisib Shows Impressive PFS in HR+/HER2– Breast ... New clinical trial results reveal gedatolisib significantly improves progression-free survival in advanced HR+/HER2– breast cancer, offering ...

6. esmoopen.com esmoopen.com/article/S2059-7029(23)00619-1/fulltext

204P Phase Ib study of gedatolisib plus palbociclib and ... The safety profile of gedatolisib + palbo + LET was similar to palbo + LET. These encouraging results warrant further evaluation of gedatolisib in combination ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.1021

Phase II study of trastuzumab-pkrb plus gedatolisib in ... Safety and efficacy outcomes were evaluated, with a data cutoff of December 31, 2024. Results: Primary efficacy and safety data were evaluable ...