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Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCelcuity Inc

About this trial

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HR+/HER2- breast cancer

Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue for the duration of the study.

Negative pregnancy test for females of childbearing potential. Female subjects who are not surgically sterile must use a medically effective contraceptive method from screening until 2 years after the last dose of study treatment.

Progression of disease during or within 12 months of completing (neo)adjuvant endocrine therapy (ET) or progression of disease after 12 months of completing (neo)adjuvant ET.

Disqualifiers

Concurrent malignancies other than adequately treated non-melanoma skin cancer. Previous malignancies in remission but curatively treated with no evidence of disease progression and judged by local Investigator to be at low risk of impacting health or survival while on study.

Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor or any other selective estrogen receptor degrader (SERD), except fulvestrant, used in (neo)adjuvant setting.

Prior treatment with systemic anticancer therapy for ABC

Subjects with type 1 diabetes, or uncontrolled type 2 diabetes requiring daily insulin therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Arm A: Gedatolisib + Palbociclib + Fulvestrant

    Drug

    Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off Other Names: • PF-05212384 Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle. Other Names: • IBRANCE Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant every 2 weeks during Cycle 1 and then every 4 weeks Other Names: • Faslodex

  • Arm B: Ribociclib + Fulvestrant

    Drug

    Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Other Names: • KISQALI® Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant approximately every 2 weeks during Cycle 1 then approximately every 4 weeks Other Names: • Faslodex

  • Arm C: Gedatolisib + Palbociclib + Letrozole

    Drug

    Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle. Drug: Letrozole Participants will receive oral letrozole daily.

  • Arm D: Ribociclib + Letrozole

    Drug

    Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Drug: Letrozole Participants will receive oral letrozole daily.

Treatment groups

1,180 Participants
are divided into 4 treatment groups
Group A: Arm A: Gedatolisib + Palbociclib + FulvestrantExperimental treatment 1 intervention
Group B: Arm B: Ribociclib + FulvestrantActive comparator 1 intervention
Group C: Arm C: Gedatolisib + Palbociclib + LetrozoleExperimental treatment 1 intervention
Group D: Arm D: Ribociclib + LetrozoleActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

PFS is defined as the time from randomization to death or the first documented progression, whichever occurs first, confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as determined based on blinded independent central review (BICR)

Time frame
From date of randomization to the date of death due to any cause, up to approximately 48 months

Secondary outcomes

1

Overall Survival (OS)

OS is defined as the length of time from randomization until the date of death from any cause method, where PFS is defined as the time from randomization to death or the first documented progression, whichever occurs first, confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as determined based on blinded independent central review (BICR)

Time frame
From date of randomization to the date of death due to any cause, up to approximately 48 months
2

Overall Response Rate (ORR)

Percentage of subjects who achieved an objective response according to RECIST v1.1 criteria (complete response \[CR\] or partial response \[PR\]) as assessed by BICR)

Time frame
Up to approximately 48 months
3

Duration of Response (DOR)

Time from the assessment of initial response (PR or better) to death or first documented radiologically confirmed disease progression as assessed by BICR, whichever occurs first

Time frame
Up to approximately 48 months
4

Time to Response (TTR)

Time to Response (TTR)

Time frame
Time from randomization to the first assessment of PR or better as assessed by BICR

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Celcuity Inc

Lead sponsor

Source ClinicalTrials.gov
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