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Platinum-based Chemotherapy

Triple Drug Combo for Breast Cancer

Phase 1 & 2

Waitlist Available

Led By Priyanka Sharma, MD

Research Sponsored by Priyanka Sharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Breast cancer that is either stage III disease not amenable to curative therapy or stage IV

Eastern Oncology Cooperative Group (ECOG) Performance status of ≥ 2

Must not have

Subject has a concurrent malignancy or malignancy within 3 years of study enrollment

Subject has known history of testing positive for HIV or AIDS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial found a combination of 3 drugs effective at treating metastatic TNBC & BRCA-mutated breast cancer.

Who is the study for?

This trial is for adults with triple negative breast cancer or BRCA mutation-associated breast cancer that's locally recurrent or metastatic. They must have had prior chemotherapy, be in a stable condition if they've had brain metastasis treatment, and not be pregnant. Those with certain health conditions, recent surgeries, active infections, or severe allergies are excluded.

What is being tested?

The study tests a combination of cisplatin (a chemotherapy drug), romidepsin (an anticancer agent), and nivolumab (an immunotherapy) on patients with advanced breast cancer to see how well it works compared to existing treatments.

What are the potential side effects?

Potential side effects include immune-related reactions like inflammation in organs, infusion-related symptoms such as fever or chills, fatigue from the therapy drugs themselves, possible blood count changes leading to increased infection risk and other common chemotherapy-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is at an advanced stage and cannot be cured with surgery or radiation.

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My daily activity is limited due to my health condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer within the last 3 years or have another cancer now.

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I have tested positive for HIV/AIDS.

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My nerve damage does not severely affect my daily activities.

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I have an ongoing infection that isn't under control.

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I am currently on medication that affects the enzyme CYP3A.

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I have untreated brain symptoms.

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I still have side effects from previous treatments that haven't improved much.

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I haven't had any cancer treatment in the last 14 days or within 5 half-lives of the treatment.

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My liver disease is severe.

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I have inflammatory breast cancer.

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I have tested positive for hepatitis B or C.

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I am currently taking warfarin or a similar blood thinner.

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I have heart problems or a history of heart issues.

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I haven't had major surgery in the last 2 weeks or still have major side effects from it.

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I have been treated with specific drugs for my condition before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 1 & 2 trial • 51 Patients • NCT01456039

100%

Dysgeusia

100%

Leukopenia

100%

Thrombocytopenia

100%

Lymphopenia

100%

Neutropenia

100%

Nausea

100%

Vomiting

100%

Pyrexia

100%

Fatigue

100%

Decreased appetite

100%

Peripheral Sensory neuropathy

67%

Diarrhoea

67%

Anaemia

67%

Lip dry

67%

Haemoglobin decreased

67%

Weight decreased

67%

Blood phosphorus increased

67%

Hypotension

67%

Insomnia

33%

Hypokalaemia

33%

Oedema peripheral

33%

Hyperhidrosis

33%

Alanine aminotransferase increased

33%

Akathisia

33%

Hypocalcaemia

33%

Cancer Pain

33%

Vitreous Floaters

33%

Biliary colic

33%

Abdominal pain upper

33%

Dental caries

33%

Gastritis

33%

Hypothermia

33%

Influenza like illness

33%

Non-cardiac chest pain

33%

Hypermagnesaemia

33%

Hyperuricaemia

33%

Blood alkaline phosphatase increased

33%

Blood urea increased

33%

Somnolence

33%

Rash macular

33%

Hypoxia

33%

Arthralgia

33%

Back Pain

33%

Musculoskeletal stiffness

33%

Osteoarthritis

33%

Periarthritis

33%

Nasopharyngitis

33%

Influenza

33%

Upper respiratory tract infection

33%

Long QT syndrome

33%

Contusion

33%

Procedural Pain

33%

Phlebitis

33%

Pollakiuria

33%

Headache

33%

Hiccups

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1: Romidepsin 9mg/m^2

Phase 1: Romidepsin 14mg/m^2

Phase 2: Romidepsin 14mg/m^2

Total: Romidepsin 14mg/m^2

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Romidepsin Dose ExpansionExperimental Treatment3 Interventions

Romidepsin maximum tolerated dose (MTD) from Phase I IV on days 2 \& 9 of each 21 day cycle Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle Nivolumab 360mg on day 1 of each 21 day cycle

Group II: Romidepsin (8mg/m2) + Cisplatin (75mg/m2)Experimental Treatment2 Interventions

Romidepsin 8mg/m2 IV on days 2 \& 9 of each 21 day cycle Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle

Group III: Romidepsin (12mg/m2) + Cisplatin (75mg/m2)Experimental Treatment2 Interventions

Romidepsin 12mg/m2 IV on days 2 \& 9 of each 21 day cycle Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle

Group IV: Romidepsin (10mg/m2) + Cisplatin (75mg/m2)Experimental Treatment2 Interventions

Romidepsin 10mg/m2 IV on days 2 \& 9 of each 21 day cycle Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Romidepsin

2011