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Alkylating agents
Carboplatin vs. Carboplatin + Everolimus for Advanced Breast Cancer
Phase 2
Waitlist Available
Led By Amy Tiersten, MD
Research Sponsored by amy tiersten
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Summary
This trial will compare the safety and effectiveness of carboplatin to a combination of carboplatin and everolimus for the treatment of advanced TNBC.
Who is the study for?
This trial is for women over 18 with advanced triple-negative breast cancer, including those with stable brain metastases. Participants can have had up to three prior treatments and must have good organ function and performance status. Pregnant or breastfeeding women, individuals on certain drugs, or those with severe medical conditions are excluded.
What is being tested?
The study compares the effectiveness of Carboplatin alone versus a combination of Carboplatin and Everolimus in treating advanced triple-negative breast cancer. The goal is to determine which treatment is safer and more effective.
What are the potential side effects?
Potential side effects include allergic reactions to the drugs, blood count changes, kidney or liver function alterations, fatigue, risk of infection due to immune suppression from Everolimus, mouth sores, rash and possibly lung problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progress-free survival (PFS)
Secondary study objectives
Clinical Benefit Rate
Overall Response Rate (ORR)
Overall Survival
Side effects data
From 2022 Phase 3 trial • 1301 Patients • NCT0303810060%
ALOPECIA
51%
NAUSEA
45%
ARTHRALGIA
44%
ANAEMIA
38%
FATIGUE
35%
CONSTIPATION
35%
DIARRHOEA
35%
HYPERTENSION
30%
NEUTROPENIA
28%
ABDOMINAL PAIN
28%
NEUTROPHIL COUNT DECREASED
28%
PERIPHERAL SENSORY NEUROPATHY
24%
NEUROPATHY PERIPHERAL
24%
RASH
23%
VOMITING
23%
HEADACHE
22%
WHITE BLOOD CELL COUNT DECREASED
22%
MYALGIA
21%
PLATELET COUNT DECREASED
21%
PROTEINURIA
21%
EPISTAXIS
21%
THROMBOCYTOPENIA
19%
DECREASED APPETITE
18%
HYPOTHYROIDISM
17%
URINARY TRACT INFECTION
16%
PYREXIA
16%
COUGH
15%
STOMATITIS
14%
ALANINE AMINOTRANSFERASE INCREASED
14%
ASPARTATE AMINOTRANSFERASE INCREASED
14%
HYPOMAGNESAEMIA
14%
BACK PAIN
14%
INSOMNIA
14%
DYSPNOEA
14%
PRURITUS
13%
WEIGHT DECREASED
13%
PAIN IN EXTREMITY
12%
ASTHENIA
12%
INFUSION RELATED REACTION
12%
DIZZINESS
11%
LEUKOPENIA
11%
HYPOKALAEMIA
10%
UPPER RESPIRATORY TRACT INFECTION
9%
DYSGEUSIA
8%
FEBRILE NEUTROPENIA
8%
ABDOMINAL PAIN UPPER
8%
HYPOAESTHESIA
8%
WEIGHT INCREASED
8%
HYPERTHYROIDISM
7%
MUCOSAL INFLAMMATION
7%
LYMPHOCYTE COUNT DECREASED
7%
HYPONATRAEMIA
7%
BONE PAIN
7%
MUSCULAR WEAKNESS
7%
PARAESTHESIA
7%
DYSPHONIA
7%
OROPHARYNGEAL PAIN
7%
DYSPEPSIA
7%
RASH MACULO-PAPULAR
7%
HYPERGLYCAEMIA
6%
OEDEMA PERIPHERAL
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
NASOPHARYNGITIS
6%
ABDOMINAL DISTENSION
6%
ANXIETY
5%
DRY MOUTH
5%
MALAISE
5%
DEPRESSION
5%
NASAL CONGESTION
5%
PAIN
5%
VISION BLURRED
5%
DRY SKIN
5%
URTICARIA
5%
HOT FLUSH
5%
NECK PAIN
4%
GASTROOESOPHAGEAL REFLUX DISEASE
2%
ILEUS
2%
PNEUMONIA
2%
PULMONARY EMBOLISM
2%
COLITIS
2%
SMALL INTESTINAL OBSTRUCTION
1%
INTESTINAL OBSTRUCTION
1%
LIVER INJURY
1%
PERITONITIS
1%
UROSEPSIS
1%
DEHYDRATION
1%
TRANSIENT ISCHAEMIC ATTACK
1%
PNEUMONITIS
1%
ABDOMINAL ABSCESS
1%
INFECTED LYMPHOCELE
1%
PYELONEPHRITIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Placebo With Paclitaxel, Carboplatin and Bevacizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Carboplatin + EverolimusExperimental Treatment2 Interventions
Carboplatin AUC 4 every 3 weeks IV infusion plus daily oral everolimus 5mg pill
Group II: Carboplatin aloneActive Control1 Intervention
AUC 4 every 3 weeks as an IV infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Everolimus
FDA approved
Find a Location
Who is running the clinical trial?
amy tierstenLead Sponsor
Amy TierstenLead Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled
NovartisIndustry Sponsor
1,636 Previous Clinical Trials
2,773,545 Total Patients Enrolled
57 Trials studying Breast Cancer
21,238 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer in the past 3 years, except for treated skin cancer or cervical cancer.I am a woman with breast cancer that has spread, including to bones.I haven't had any cancer treatments in the last 2 weeks.I haven't had major surgery or significant injury in the last 4 weeks and don't expect to need major surgery soon.I have brain metastases that are not under control.I am not taking strong medication inhibitors like ketoconazole.I've been on a stable dose of low-dose steroids or no immunosuppressants for over 4 weeks.I have not had any live vaccines in the last week and will avoid close contact with those who have.My kidney function is normal, with creatinine levels within the acceptable range.My cancer has spread to the lining of my brain and spinal cord.I do not have severe health issues that could affect my study participation.My breast cancer is triple negative.I am 18 years old or older.I have had up to 3 treatments for my cancer after it spread.My brain metastases have been stable for over 2 weeks after treatment, and I am not on steroids.You need to have a CT scan of your chest, abdomen, and pelvis, and a bone scan or PET/CT before joining the study.You need to have a negative pregnancy test no more than 7 days before starting treatment.It's been over a year since my last carboplatin treatment.My liver tests are within the required range.I can perform light activities but not work.My blood tests show normal white blood cells, platelets, and hemoglobin levels.
Research Study Groups:
This trial has the following groups:- Group 1: Carboplatin alone
- Group 2: Carboplatin + Everolimus
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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.
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