Tests tenalisib in people with advanced triple negative breast cancer
Tests tenalisib in adults with spread triple negative breast cancer after prior treatments.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
Key facts
- Where
- Bangalore, Hyderabad, Kolkata, Madurai, Mumbai, Pune, and Vijayawada, IndiaSee the 9 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with metastatic triple negative breast cancer who have already had 1 to 3 chemotherapy regimens for metastatic disease.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Metastatic triple negative breast cancer confirmed by tissue examination, with at least one measurable lesion (RECIST version 1.1). Bone-only disease is not allowed.
- Earlier treatment
- Must have had at least 1 but not more than 3 chemotherapy regimens for metastatic disease. Must not have had a PI3K inhibitor (for example alpelisib, buparlisib) for breast cancer.
Main reasons for not taking part
- Cancer treatment or an investigational cancer drug within 3 weeks (21 days) or 5 half-lives, whichever is shorter
- Symptomatic uncontrolled brain metastasis
- Ongoing immunosuppressive therapy, including systemic corticosteroids
- History of severe skin reactions
- Pregnancy or breastfeeding
Read by machine on 9 November 2026.
Where in India
- Narayana Hrudayala Majumdar Shaw HospitalBangalore, IndiaTaking people
- Nizams Institute of Medical ScienceHyderabad, IndiaNot yet recruiting
- Health Point HospitalKolkata, IndiaTaking people
- Meenakshi Mission Hospital & Research CenterMadurai, IndiaNot yet recruiting
- Mumbai Oncocare CentreMumbai, IndiaTaking people
- Tata Memorial CentreMumbai, IndiaTaking people
- Nobel HospitalPune, IndiaTaking people
- Sahyadri Super Speciality HospitalPune, IndiaTaking people
- HCG City Cancer CenterVijayawada, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rhizen Pharmaceuticals SA
- Trial code
- NCT06189209
- Record updated
- 2 December 2025
- Original description
This is a Phase II, open-label, single-arm, study, designed to evaluate the efficacy and safety of tenalisib in patients with metastatic TNBC, who have received at least one but not more than 3 prior therapies in a metastatic setting.Read full original descriptionShow less
A Phase II, Multi-center, Single-arm, Open-label Study to Assess the Efficacy and Safety of Tenalisib, a PI3K δ/γ, and SIK3 Inhibitor, in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
This is a Phase II, open-label, single-arm, study, designed to evaluate the efficacy and safety of tenalisib in patients with metastatic TNBC, who have received at least one but not more than 3 prior therapies in a metastatic setting.
Inclusion: Patients who have histologically confirmed TNBC; Patients who have received at least 1 but not more than 3 prior chemotherapy regimens in a metastatic setting; Patients with at least one measurable lesion, per RECIST version 1.1 at baseline . Bone-only disease is not permitted; ECOG performance status 0 to 2; Adequate bone marrow, liver, and renal function.
Exclusion: Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter); Patient who has not recovered from acute toxicities of previous therapy except treatment-related alopecia; Prior exposure to PI3K inhibitors (e.g., alpelisib, buparlisib) for breast cancer; Major surgery within 4 weeks of starting study treatment; Ongoing immunosuppressive therapy including systemic corticosteroids; Concurrent disease or condition that would interfere with study participation; History of severe cutaneous reactions; Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation; Patient with symptomatic uncontrolled brain metastasis; Pregnancy or lactation.