Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My breast cancer is at an advanced stage and cannot be cured with surgery or radiation.
Select...
My daily activity is limited due to my health condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: Recommended Phase II Dose of romidepsin in combination with cisplatin
Phase II: Objective response rate of treated subjects according to RECIST v1.1 criteria
Secondary outcome measures
Median Progression-Free Survival and Overall Survival
Pharmacokinetics - cisplatin plasma concentration vs time profile when given with romidepsin
Pharmacokinetics - romidepsin plasma concentration vs time profile when given with cisplatin and nivolumab
+1 moreSide effects data
From 2018 Phase 1 & 2 trial • 51 Patients • NCT01456039100%
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%
Alanine aminotransferase increased
33%
Akathisia
33%
Oedema peripheral
33%
Hypocalcaemia
33%
Hyperhidrosis
33%
Vitreous Floaters
33%
Cancer Pain
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%
0%
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
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
Completed Phase 2
~790
Cisplatin
2013
Completed Phase 3
~1940
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,642 Previous Clinical Trials
4,130,072 Total Patients Enrolled
50 Trials studying Breast Cancer
8,214 Patients Enrolled for Breast Cancer
Priyanka SharmaLead Sponsor
2 Previous Clinical Trials
144 Total Patients Enrolled
1 Trials studying Breast Cancer
43 Patients Enrolled for Breast Cancer
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,185 Total Patients Enrolled
15 Trials studying Breast Cancer
674 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have triple-negative breast cancer or a confirmed BRCA1/2 mutation.I have had cancer within the last 3 years or have another cancer now.I do not have any mental or physical health conditions that would make cancer treatment too risky for me.I have tested positive for HIV/AIDS.I have taken steroids within the last 2 weeks or am still experiencing their side effects.My nerve damage does not severely affect my daily activities.My breast cancer is at an advanced stage and cannot be cured with surgery or radiation.I've had chemotherapy and, if applicable, hormonal therapy for my cancer.I have an ongoing infection that isn't under control.I had brain metastasis treatment over 2 weeks ago and have no CNS symptoms.I am currently on medication that affects the enzyme CYP3A.You are allergic to certain ingredients in the study drug.I have untreated brain symptoms.I still have side effects from previous treatments that haven't improved much.I haven't had any cancer treatment in the last 14 days or within 5 half-lives of the treatment.My liver disease is severe.I have inflammatory breast cancer.I had radiation for bone metastases at least 14 days before starting the study treatment.I have tested positive for hepatitis B or C.I am currently taking warfarin or a similar blood thinner.I have heart problems or a history of heart issues.I haven't had major surgery in the last 2 weeks or still have major side effects from it.My daily activity is limited due to my health condition.I am using contraception and will continue for 5 months after treatment.You have a visible abnormality in your body that is at least 2 cm in size using regular methods or at least 1 cm on a special type of CT scan.I have had treatments for metastatic breast cancer, but not cisplatin unless it was part of early treatment.I am taking medication for cancer that has spread to my bones.I have been treated with specific drugs for my condition before.Your test results need to be within certain ranges.You have a known autoimmune disease that is currently active or suspected.
Research Study Groups:
This trial has the following groups:- Group 1: Romidepsin (10mg/m2) + Cisplatin (75mg/m2)
- Group 2: Romidepsin Dose Expansion
- Group 3: Romidepsin (12mg/m2) + Cisplatin (75mg/m2)
- Group 4: Romidepsin (8mg/m2) + Cisplatin (75mg/m2)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger