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Alkylating agents
Carboplatin +/− Nivolumab for Breast Cancer
Phase 2
Waitlist Available
Led By Sara Tolaney, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must agree to undergo a research biopsy, if tumor is safely accessible, at baseline
Prior biologic therapy: Prior poly-ADP ribose polymerase (PARP) inhibitors are not allowed in the metastatic setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed from the time measurement criteria are met for cr or pr by recist 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years
Awards & highlights
Study Summary
This trial is testing the effectiveness of Carboplatin with or without Nivolumab as a treatment for triple-negative breast cancer that has metastasized.
Who is the study for?
This trial is for women over 18 with metastatic triple-negative breast cancer who haven't had chemotherapy for it yet. They must not be pregnant, have normal organ function, and no history of certain cancers or immune conditions. Participants need to agree to use contraception and can undergo a biopsy if needed.Check my eligibility
What is being tested?
The study tests Carboplatin alone versus Carboplatin combined with Nivolumab in treating advanced breast cancer. It aims to see if adding Nivolumab improves outcomes. Patients will be assigned randomly to receive either the single drug or the combination therapy.See study design
What are the potential side effects?
Carboplatin may cause nausea, low blood counts leading to infection risk, kidney issues, and allergic reactions. Nivolumab could lead to immune-related side effects like inflammation in organs such as lungs (pneumonitis), liver problems, skin rash, and endocrine disorders.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to a research biopsy if my tumor can be safely accessed.
Select...
I have not taken PARP inhibitors for metastatic cancer.
Select...
My breast cancer is advanced and cannot be removed by surgery.
Select...
My cancer is negative for estrogen, progesterone receptors, and HER2.
Select...
My PD-L1 status is known.
Select...
My organ and bone marrow functions are normal.
Select...
I understand the study requirements and agree to participate.
Select...
I am mostly able to care for myself and carry out daily activities.
Select...
I am 18 years old or older.
Select...
I agree to use birth control during and for 7 months after my treatment.
Select...
I have not received chemotherapy for metastatic breast cancer before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed from the time measurement criteria are met for cr or pr by recist 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed from the time measurement criteria are met for cr or pr by recist 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival
Secondary outcome measures
Clinical Benefit Rate
Clinical Benefit Rate Among BRCA-mutant Patients
Clinical Benefit Rate Among PD-L1-positive Patients
+24 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Neoplasm progression
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Carboplatin + NivolumabExperimental Treatment2 Interventions
Nivolumab is administered every three weeks intravenously
Nivolumab dosage is 360mg
Carboplatin is administered every three weeks intravenously
Carboplatin dosage is pre-determined by the PI
Group II: CarboplatinActive Control1 Intervention
Carboplatin is administered every three weeks intravenously
Carboplatin dosage is pre-determined by the PI
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,794 Total Patients Enrolled
141 Trials studying Breast Cancer
22,539 Patients Enrolled for Breast Cancer
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,436 Total Patients Enrolled
50 Trials studying Breast Cancer
8,187 Patients Enrolled for Breast Cancer
Sara Tolaney, MDPrincipal InvestigatorDana-Farber Cancer Institute
5 Previous Clinical Trials
160 Total Patients Enrolled
2 Trials studying Breast Cancer
78 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have HIV, Hepatitis B, or Hepatitis C.I have not had major surgery in the last 2 weeks.I agree to a research biopsy if my tumor can be safely accessed.I have not taken PARP inhibitors for metastatic cancer.I am a woman who can have children and have a recent negative pregnancy test.I am currently taking bisphosphonates or RANK ligand inhibitors and can continue them during the study.I am allergic to platinum-based chemotherapy or nivolumab.I have brain metastases that are either untreated, causing symptoms, or need treatment for symptoms.I do not have any severe illnesses that are not under control.My breast cancer is advanced and cannot be removed by surgery.My cancer is negative for estrogen, progesterone receptors, and HER2.My PD-L1 status is known.My organ and bone marrow functions are normal.I am receiving supportive care like blood transfusions to meet the trial's requirements.I understand the study requirements and agree to participate.I have been treated with specific immune therapy before.I have a history of lung inflammation not caused by an infection.Participants must have a way to measure their disease according to specific guidelines.I have had radiation therapy before.I am mostly able to care for myself and carry out daily activities.I am 18 years old or older.I am currently on steroids or immunosuppressants for an autoimmune disease.I agree to use birth control during and for 7 months after my treatment.I have not received chemotherapy for metastatic breast cancer before.I agree to use birth control during the study.I have had cancer before, but it fits the exceptions for this trial.I have not received a live vaccine in the last 28 days.I am on long-term steroids or other drugs that weaken my immune system.I am not on any cancer treatments except for bisphosphonates or RANK ligand inhibitors.
Research Study Groups:
This trial has the following groups:- Group 1: Carboplatin + Nivolumab
- Group 2: Carboplatin
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.
What is the aggregate figure of participants in this research?
"This clinical trial is now closed for recruitment. It was initially posted on January 30th 2018 and last updated October 3rd 2022. Currently, there are 2659 studies actively recruiting breast cancer patients, with 1373 of those trials specifically utilizing Nivolumab as an intervention."
Answered by AI
Have any past experiments explored the effects of Nivolumab?
"Since 2002, nivolumab has been the subject of 1076 completed experiments with 1373 trials still in progress. These studies are being conducted primarily out of Boston and Ohio, with their origin stretching back to H Central de Asturias."
Answered by AI
Does the FDA recognize Nivolumab as a viable medical drug?
"Our team at Power has assigned Nivolumab a score of 2, as this is currently undergoing Phase 2 trials. Consequently there is only limited evidence supporting safety, with no data to suggest efficacy yet."
Answered by AI
In what circumstances is Nivolumab typically prescribed as a treatment?
"Nivolumab is a potential therapy for malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Answered by AI
Are candidates still being accepted for this clinical experiment?
"According to clinicaltrials.gov, this medical trial is no longer recruiting patients - the original post dates back to January 30th 2018 and was last updated on October 3rd 2022. Nevertheless, there are still 4032 other studies that require participants at present."
Answered by AI
Are there multiple healthcare facilities conducting this research experiment in Canada?
"This experimental treatment is currently being offered in 11 different sites, including Boston, Columbus and Stamford. If you decide to join the trial it's important that you select a location nearby to reduce travel burdens."
Answered by AI
What objectives has this experiment been designed to fulfill?
"This roughly 3.5-year study is focused on measuring Progression-free survival (PFS) and other secondary objectives, such as Efficacy of nab-paclitaxel during second course therapy for crossover patients, efficacy among BRCA mutant patients, and Objective Response Rate by Immune Related Response Criteria (irRC)."
Answered by AI
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