Evaluating Tenalisib for Metastatic Triple Negative Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II, open-label, single-arm study aims to assess the efficacy and safety of tenalisib in patients diagnosed with metastatic triple negative breast cancer (TNBC). Eligible participants must have received between one and three prior therapies in a metastatic setting and have at least one measurable lesion. The study will monitor the treatment's effectiveness and safety profile in this specific patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients who have histologically confirmed TNBC.
2. Patients who have received at least 1 but not more than 3 prior chemotherapy regimens in a metastatic setting.
3. Patients with at least one measurable lesion, per RECIST version 1.1 at baseline . Bone-only disease is not permitted.
4. ECOG performance status 0 to 2.
5. Adequate bone marrow, liver, and renal function

Exclusion Criteria:

1. Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter).
2. Patient who has not recovered from acute toxicities of previous therapy except treatment-related alopecia.
3. Prior exposure to PI3K inhibitors (e.g., alpelisib, buparlisib) for breast cancer.
4. Major surgery within 4 weeks of starting study treatment.
5. Patient with symptomatic uncontrolled brain metastasis.
6. Ongoing immunosuppressive therapy including systemic corticosteroids.
7. History of severe cutaneous reactions.
8. Concurrent disease or condition that would interfere with study participation
9. Pregnancy or lactation.
10. Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation

Where it's running

• HCG City Cancer Center
  Vijayawada, Andhra Pradesh, India Recruiting
• Narayana Hrudayala Majumdar Shaw Hospital
  Bangalore, Karnataka, India Recruiting
• Tata Memorial Centre
  Mumbai, Maharashtra, India Recruiting
• Mumbai Oncocare Centre
  Mumbai, Maharashtra, India Recruiting
• Sahyadri Super Speciality Hospital
  Pune, Maharashtra, India Recruiting
• Nobel Hospital
  Pune, Maharashtra, India Recruiting

Study contacts

• Study coordinator: Prajak Barde, MD
• Email: pjb@rhizen.com
• Phone: +41325800175

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.