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New hope for Hard-to-Treat breast cancer: drug trial targets advanced TNBC

NCT ID NCT06189209

Disease control Sponsor: Rhizen Pharmaceuticals SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called tenalisib in 40 people with metastatic triple negative breast cancer (TNBC) who have already tried 1 to 3 other treatments. The goal is to see if tenalisib can shrink tumors or stop them from growing for at least 16 weeks. Researchers will also monitor side effects and drug levels in the blood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Triple negative breast cancer (TNBC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • HCG City Cancer Center

    RECRUITING

    Vijayawada, Andhra Pradesh, 520002, India

  • Health Point Hospital

    RECRUITING

    Kolkata, West Bengal, 700025, India

  • Meenakshi Mission Hospital & Research Center

    NOT_YET_RECRUITING

    Madurai, Tamil Nadu, 625107, India

  • Mumbai Oncocare Centre

    RECRUITING

    Mumbai, Maharashtra, 400056, India

  • Narayana Hrudayala Majumdar Shaw Hospital

    RECRUITING

    Bangalore, Karnataka, 560099, India

  • Nizams Institute of Medical Science

    NOT_YET_RECRUITING

    Hyderabad, Telangana, 500082, India

  • Nobel Hospital

    RECRUITING

    Pune, Maharashtra, 411013, India

  • Sahyadri Super Speciality Hospital

    RECRUITING

    Pune, Maharashtra, 411004, India

  • Tata Memorial Centre

    RECRUITING

    Mumbai, Maharashtra, 400012, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.