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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
Women with metastatic breast cancer (measurable or evaluable including bone metastases only)
Adequate liver function: serum bilirubin ≤ 1.5 x ULN, ALT and AST ≤ 2.5x ULN (≤ 5x ULN in patients with liver metastases)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman with breast cancer that has spread, including to bones.
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My liver tests are within the required range.
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My kidney function is normal, with creatinine levels within the acceptable range.
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My breast cancer is triple negative.
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I am 18 years old or older.
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I have had up to 3 treatments for my cancer after it spread.
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My brain metastases have been stable for over 2 weeks after treatment, and I am not on steroids.
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It's been over a year since my last carboplatin treatment.
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I can perform light activities but not work.
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My blood tests show normal white blood cells, platelets, and hemoglobin levels.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progress-free survival (PFS)
Secondary outcome measures
Clinical Benefit Rate
Overall Response Rate (ORR)
Overall Survival

Side effects data

From 2022 Phase 3 trial • 1301 Patients • NCT03038100
60%
ALOPECIA
51%
NAUSEA
45%
ARTHRALGIA
44%
ANAEMIA
38%
FATIGUE
35%
DIARRHOEA
35%
CONSTIPATION
35%
HYPERTENSION
30%
NEUTROPENIA
28%
PERIPHERAL SENSORY NEUROPATHY
28%
ABDOMINAL PAIN
28%
NEUTROPHIL COUNT DECREASED
24%
NEUROPATHY PERIPHERAL
24%
RASH
23%
HEADACHE
23%
VOMITING
22%
WHITE BLOOD CELL COUNT DECREASED
22%
MYALGIA
21%
PROTEINURIA
21%
PLATELET COUNT DECREASED
21%
THROMBOCYTOPENIA
21%
EPISTAXIS
19%
DECREASED APPETITE
18%
HYPOTHYROIDISM
17%
URINARY TRACT INFECTION
16%
PYREXIA
16%
COUGH
15%
STOMATITIS
14%
BACK PAIN
14%
INSOMNIA
14%
HYPOMAGNESAEMIA
14%
ASPARTATE AMINOTRANSFERASE INCREASED
14%
ALANINE AMINOTRANSFERASE INCREASED
14%
DYSPNOEA
14%
PRURITUS
13%
WEIGHT DECREASED
13%
PAIN IN EXTREMITY
12%
DIZZINESS
12%
ASTHENIA
12%
INFUSION RELATED REACTION
11%
LEUKOPENIA
11%
HYPOKALAEMIA
10%
UPPER RESPIRATORY TRACT INFECTION
9%
DYSGEUSIA
8%
ABDOMINAL PAIN UPPER
8%
HYPOAESTHESIA
8%
WEIGHT INCREASED
8%
FEBRILE NEUTROPENIA
8%
HYPERTHYROIDISM
7%
DYSPHONIA
7%
MUCOSAL INFLAMMATION
7%
PARAESTHESIA
7%
BONE PAIN
7%
MUSCULAR WEAKNESS
7%
HYPONATRAEMIA
7%
LYMPHOCYTE COUNT DECREASED
7%
OROPHARYNGEAL PAIN
7%
DYSPEPSIA
7%
RASH MACULO-PAPULAR
7%
HYPERGLYCAEMIA
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
OEDEMA PERIPHERAL
6%
NASOPHARYNGITIS
6%
ABDOMINAL DISTENSION
6%
ANXIETY
5%
MALAISE
5%
DEPRESSION
5%
DRY MOUTH
5%
VISION BLURRED
5%
DRY SKIN
5%
URTICARIA
5%
HOT FLUSH
5%
PAIN
5%
NECK PAIN
5%
NASAL CONGESTION
4%
GASTROOESOPHAGEAL REFLUX DISEASE
2%
PNEUMONIA
2%
ILEUS
2%
PULMONARY EMBOLISM
2%
COLITIS
2%
SMALL INTESTINAL OBSTRUCTION
1%
PERITONITIS
1%
INTESTINAL OBSTRUCTION
1%
DEHYDRATION
1%
LIVER INJURY
1%
TRANSIENT ISCHAEMIC ATTACK
1%
PNEUMONITIS
1%
ABDOMINAL ABSCESS
1%
INFECTED LYMPHOCELE
1%
PYELONEPHRITIS
1%
UROSEPSIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Placebo With Paclitaxel, Carboplatin and Bevacizumab

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
1,607 Previous Clinical Trials
2,709,729 Total Patients Enrolled
56 Trials studying Breast Cancer
21,126 Patients Enrolled for Breast Cancer

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02531932 — Phase 2
Breast Cancer Research Study Groups: Carboplatin alone, Carboplatin + Everolimus
Breast Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02531932 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02531932 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What has Carboplatin shown to be most effective in treating?

"While often used to treat advanced sarcoma, carboplatin can also be an effective way of managing refractory advanced renal cell carcinoma, initial treatment, and advanced thymoma."

Answered by AI

Are new participants being signed up for this experiment at this time?

"This study, as reflected on clinicaltrials.gov, is still recruiting patients for the trial. The first posting was on August 1st, 2015 with the most recent edit being on October 22nd, 2021."

Answered by AI

Are there any known risks associated with Carboplatin?

"There is some data indicating that Carboplatin is safe, but none yet supporting that it is effective. We rated it a 2."

Answered by AI

How many volunteers are helping to test this new medication?

"That is correct. Based on the information available from clinicaltrials.gov, it appears that this research project is still recruiting patients. The trial was first posted on 8/1/2015, and the most recent update was on 10/22/2021. They are looking for a total of 72 participants who will be located at 3 different sites."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~6 spots leftby Mar 2025