Phase 3 Study of Gedatolisib in HR-Positive, HER2-Negative Advanced Breast Cancer Patients (VIKTORIA-1)
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2023/08/056738
- Lead Sponsor
- PSI CRO Pharma India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Subjects must meet the following inclusion criteria:
1.Adults =18 years of age and meet one of the following criteria:
a.Women who are postmenopausal, defined as one of the following: i.Women 18–59 years of age (at the time of consent) with cessation of regular menses for =12 consecutive months with no alternative pathological or physiological cause, and serum estradiol and FSH level within the range for postmenopausal females. ii.Women =60 years of age with cessation of menses for =12 consecutive months. iii.Bilateral oophorectomy. iv.Ovarian failure. b.Pre/perimenopausal women with medically-induced menopause
c.Male subjects must use a contraceptive method from screening until 1 year after the last dose of study treatment. 2.Negative pregnancy test for women who are not surgically sterile. Contraceptive use from screening until 1 year after the last dose of study treatment.
3.Histologically or cytologically confirmed diagnosis of metastatic or locally advanced breast cancer
4.Confirmed diagnosis of ER and/or PR positive, as per ASCO CAP guidelines (2020), based on most recent tumor biopsy utilizing an assay consistent with local standards
5.Documented HER2 IHC negative as per ASCO-CAP 2018 guidance
6.Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status by Therascreen®PIK3CA RGQ PCR test and identified PIK3CA status (mutant or non-mutant).
7.Subject has radiologically evaluable disease (measurable and/or non-measurable) according to RECIST v1.1, per local assessment
8.ECOG performance status of 0–1
9.Life expectancy of at least 3 months
10.Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal AI
11.Resolution of all toxicities related to prior therapies or surgical procedures to NCI CTCAE v.5.0 Grade =1 (except alopecia)
12.Left ventricular ejection fraction =50% at baseline
13.=2 weeks beyond treatment with a targeted therapy or major surgery and =3 weeks beyond chemotherapy, immunotherapy, and/or radiation therapy and recovered from all acute toxicities prior to randomization (AEs from prior anticancer agents recovered to Grade =1 or lower; except alopecia)
14.Adequate bone marrow, hepatic, renal and coagulation function as described in the study protocol
15.Must be willing and able to comply with protocol
16.Ability to understand the investigational nature of the study and sign the informed consent
Subjects must NOT meet any of the following exclusion criteria:
1.History of malignancies other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for =3 years
2.Prior treatment with a PI3K, Akt, or mTOR inhibitor
3. > one prior treatment with chemotherapy for advanced disease (prior adjuvant or neoadjuvant chemotherapy is permitted)
4. > 2 lines of prior endocrine therapy treatment
5.Bone only disease that is only blastic with no soft tissue component
6.Subjects with type 1 diabetes or uncontrolled type 2 diabetes
7.Active HIV infection (testing not mandatory; refer to protocol).
8.Known seropositive for or active viral infection with hepatitis B virus (refer to protocol)
9.Known seropositive for, or active infection with hepatitis C virus (refer to protocol)
10.Known and untreated, or active, brain or leptomeningeal metastases
a.Subjects with previously treated CNS metastases must meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment =4 weeks prior to enrollment
11.Patients with advanced, symptomatic, visceral spread that are at risk of life-threatening complication in the short-term
12.History of clinically significant cardiovascular abnormalities as described in the study protocol
13.Gastrointestinal tract disease resulting in an inability to absorb oral medication
14.History of acute pancreatitis within 12 months of screening or past medical history of chronic pancreatitis
15.Unable to swallow oral medication tablets/capsules
16.Known hypersensitivity to the study drugs or their components
17.History of pulmonary embolus or deep vein thrombosis diagnosed and/or treated within the previous 6 months
18.History of drug induced pneumonitis or interstitial lung disease
19.Current uncontrolled medical conditions that, in the opinion of the Investigator, could limit a subject’s ability to undertake study therapy or comply with study requirements
20.Pregnant or breast-feeding women
21.Concurrent participation in another clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) in Patients with PIK3CA WT & PIK3CA MT Breast Cancer. <br/ ><br>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)Timepoint: Approximately 48 months
- Secondary Outcome Measures
Name Time Method