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New triple therapy targets hard-to-treat breast cancers

NCT ID NCT02393794

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 combination of three drugs—cisplatin, romidepsin, and nivolumab—in people with advanced triple-negative breast cancer or BRCA-related breast cancer that has spread. The goal is to see if the combination can shrink tumors and control the disease. About 51 participants will receive the treatment, and researchers will monitor response and side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

51 people

The number who actually took part.

Started

Jul 2015

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Subjects must meet at least one of the following two criteria: 1. Histologically proven TNBC 2. Confirmed germline BRCA1 or BRCA2 mutation, regardless of subtype of breast cancer * Breast cancer that is either stage III disease not amenable to curative therapy or stage IV * Have at least one measurable lesion of ≥ 2 cm by conventional methods or ≥ 1 cm on spiral CT * No limit to prior therapy for metastatic breast cancer. Prior treatment with cisplatin is excluded, unless prior cisplatin treatment was given in the neo/adjuvant setting. All other platinum compounds are allowed as long as it has been 6 months since last platinum exposure. * All patients should have received at least one line of chemotherapy in either the advanced or adjuvant setting and hormonal therapy (where appropriate). Participants who have previously been treated with endocrine therapy only, and later develop triple negative disease are eligible as long as they have had one line of chemotherapy in either the advanced or adjuvant setting. * Eastern Oncology Cooperative Group (ECOG) Performance status of ≥ 2 * Laboratory values as follows: * absolute neutrophil count ≥ 1,500/uL (microliter) * platelets ≥ 100,000/uL (no transfusion allowed within 2 weeks) * hemoglobin \> 9 g/dL (which may be reached by transfusion) * total bilirubin within normal range or ≤ 1.5 x IULN (Institutional Upper Limit of Normal) if liver metastases * total bilirubin ≤ 3.0 x IULN with direct bilirubin within normal range in subjects with Gilbert's Syndrome * aspartate aminotransferase (AST) (SGOT) /Alanine transaminase (ALT) (SPGT) ≤ 2.5 x IULN or ≤ 5 x IULN if liver metastases * Serum creatinine ≤ 1.5 x IULN * International Normalized Ratio (INR) ≤ 1.5 * Serum potassium \> 3.8 mmol/L * Serum magnesium \>1.8 mg/dL * IV bisphosphonate and denosumab for bony metastatic disease is allowed * Radiation to bony metastases is allowed ≥ 14 days before starting study treatment * Subjects with previously treated brain metastasis who are free of central nervous system (CNS) symptoms and are ≥ 14 days from treatment of brain metastasis are eligible. * Women of child bearing potential and their partners must use contraception prior to study entry, continuing for 5 months after treatment. Exclusion Criteria: * Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, biologic, targeted therapy, or any investigational therapy within either 14 days or 5 half-lives (whichever is shorter), prior to study drug administration. * Subjects who have not recovered to within one grade level (not to exceed Grade 2) of their baseline following a significant adverse event or toxicity attributed to prior treatment. * Other medical or psychiatric disorder placing the subject at undue risk for treatment complications * Subject is pregnant or lactating * Subject has previously been treated with a Histone deacetylases (HDAC) inhibitor, PD-1 inhibitor, PD-L1 inhibitor, PD-L2 inhibitor, CTLA-4 inhibitor, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways * Subject tests positive for hepatitis B or C indicating acute or chronic infection * Subject has known history of testing positive for HIV or AIDS * Subject has inflammatory breast cancer * Subject has a known hypersensitivity to any of the excipients of nivolumab, cisplatin or romidepsin * Subject has a concurrent malignancy or malignancy within 3 years of study enrollment (with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer or prior ovarian/breast cancer in patients with BRCA associated breast cancer). * Subject is classified into Child-Pugh Class C * Subject has active, uncontrolled infection * Subject has symptomatic/untreated CNS disease * Subject has an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger. * Subject has active cardiac disease or a history of cardiac dysfunction, including: * Congenital long QT syndrome * Corrected QT interval (QTc) interval ≥ 500 ms on the screening ECG (using the corrected QT interval to Fridericia's formula \[QTcF\]) * Myocardial infarction within 6 months of Cycle 1 Day 1 (C1D1). * Other significant ECG abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min) * Symptomatic coronary artery disease (CAD) * An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥ 2 mm, measured from isoelectric line to the ST segment). * Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions and/or ejection fraction \< 40% by Multi Gated Acquisition Scan (MUGA) or \< 50% by echocardiogram and/or MRI * A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD) * Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes * Uncontrolled hypertension, i.e., blood pressure (BP) of ≥ 160/95; subjects who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria * Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers) * Subjects taking drugs leading to significant QT prolongation * Concomitant use of CYP3A4 inhibitors * Subject has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects * Subject is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug or who have not fully recovered from side effects of such treatment. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * Subject is currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzyme CYP3A. The subject must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the start of treatment. * Subject is currently receiving warfarin or other coumarin derived anti-coagulant for treatment. Therapy with heparin, low molecular weight heparin (LMWH), Factor Xa or fondaparinux is allowed. * Subjects with baseline peripheral neuropathy that exceeds Grade 1.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Kansas Cancer Center - Clinical Research Center

    Fairway, Kansas, 66205, United States

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064, United States

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154, United States

  • University of Kansas Cancer Center - Overland Park

    Overland Park, Kansas, 66210, United States

  • University of Kansas Cancer Center - South

    Kansas City, Missouri, 64131, United States

  • University of Kansas Cancer Center - West

    Kansas City, Kansas, 66112, United States

  • University of Kansas Cancer Center - Westwood

    Westwood, Kansas, 66205, United States

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