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Alkylating agents
Carboplatin for Breast Cancer
Phase 3
Recruiting
Led By Vicente Valero
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b
The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study Summary
This trial is testing two different chemotherapy combinations to treat triple negative breast cancer to see which is more effective.
Who is the study for?
This trial is for patients with triple-negative breast cancer who have good blood counts, no metastatic disease on imaging, and a performance status indicating they can care for themselves. They must not be pregnant or breastfeeding, haven't received certain cancer treatments before, and don't have other serious health issues that would interfere with the study.Check my eligibility
What is being tested?
The trial is testing if adding carboplatin to a chemotherapy regimen of doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel improves outcomes in treating triple-negative breast cancer compared to the regimen without carboplatin.See study design
What are the potential side effects?
Possible side effects include nausea, vomiting, hair loss, fatigue, increased risk of infection due to low blood cell counts (neutropenia), heart problems from doxorubicin hydrochloride, nerve damage from paclitaxel (neuropathy), and kidney function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer has spread to nearby lymph nodes but not to distant parts of my body.
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I have had a mastectomy or lumpectomy.
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I have been diagnosed with a type of breast cancer called invasive adenocarcinoma.
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My cancer has not spread beyond nearby lymph nodes.
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My tumor is not HER2 positive.
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I have had surgery for breast cancer, either a mastectomy or lumpectomy.
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My lumpectomy surgery removed all visible cancer and pre-cancer.
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I am fully active or can carry out light work.
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My tumor is not driven by estrogen or progesterone.
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I have had a procedure to check the status of my lymph nodes.
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My heart's pumping ability is good, confirmed by a test within the last 3 months.
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My surgery removed all visible cancer from the breast area.
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My tumor is larger than 3.0 cm and has not spread to nearby lymph nodes.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My primary tumor is classified as stage T1 to T3.
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My last surgery was within the past 60 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
IDFS
Secondary outcome measures
BCFS
DRFI
Frequencies of adverse events categorized using the National Cancer Institute CTCAE v4.0
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (AC-->WP + carboplatin)Experimental Treatment5 Interventions
Patients receive doxorubicin hydrochloride and cyclophosphamide as in Arm I. Patients then receive paclitaxel IV over 60 minutes on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (AC-->WP)Active Control4 Interventions
Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 60 minutes on day 1. Treatment repeats weekly for 12 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Cyclophosphamide
1995
Completed Phase 3
~3770
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,070 Total Patients Enrolled
9 Trials studying Breast Cancer
11,638 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,416 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Vicente ValeroPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
55 Total Patients Enrolled
1 Trials studying Breast Cancer
20 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer has spread to nearby lymph nodes but not to distant parts of my body.I have had a mastectomy or lumpectomy.You have mental health or addiction issues that may interfere with the study requirements.I have a lung condition that makes it hard for me to breathe.My kidneys are working well.I have been diagnosed with a type of breast cancer called invasive adenocarcinoma.My cancer has not spread beyond nearby lymph nodes.My tumor is not HER2 positive.I have had surgery for breast cancer, either a mastectomy or lumpectomy.My lumpectomy surgery removed all visible cancer and pre-cancer.My breast cancer is advanced (T4) or inflammatory.I am fully active or can carry out light work.I have been treated with anthracyclines or taxanes for cancer.My heart condition allows me to use the drugs in the treatment plan.I take 10 mg or more of corticosteroids daily.I don't have any other serious illnesses that would stop me from participating in the study.I have had breast cancer or DCIS on the same side before.I have had cancer other than breast cancer in the last 5 years.I am currently using hormone therapy.My tumor is not driven by estrogen or progesterone.I have received chemotherapy for my current breast cancer diagnosis before being assigned to a treatment group.I have had a procedure to check the status of my lymph nodes.I was hospitalized for DKA or HHNS in the last year.My heart's pumping ability is good, confirmed by a test within the last 3 months.My surgery removed all visible cancer from the breast area.I have active hepatitis B or C with abnormal liver tests.My tumor is larger than 3.0 cm and has not spread to nearby lymph nodes.You are allergic to any of the study drugs or their ingredients.I have an ongoing infection or need long-term antibiotics.My alkaline phosphatase levels are slightly high, but scans show no signs of cancer spread to bones.I cannot take corticosteroids due to my health condition.I am fully active or restricted in physically strenuous activity but can do light work.You have signed a form that says you agree to participate in this study, and it has been approved by the people who oversee medical research.You cannot have used any experimental treatments or medications for at least 4 weeks before starting the study.My cancer has spread to other parts of my body.I have a moderate to severe nervous system disorder.My liver tests are high, but imaging shows no cancer spread to my liver.My primary tumor is classified as stage T1 to T3.I have had breast cancer in both breasts, either at the same time or at different times.My blood pressure is not controlled by medication.My last surgery was within the past 60 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (AC-->WP)
- Group 2: Arm II (AC-->WP + carboplatin)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Can people with the condition participate in the trial at this time?
"According to the latest update on clinicaltrials.gov, this study is looking for patients as of today. The original posting was on 7/1/2015, with the most recent update being from 5/2/2022."
Answered by AI
What conditions are often diagnosed with the help of Laboratory Biomarker Analysis?
"Laboratory Biomarker Analysis is a cancer treatment most often used for lymphoma and non-hodgkin, but can also be useful in treating kaposi's sarcoma aids related, leukemia, and locally advanced non-small cell lung cancer."
Answered by AI
Has there been extensive research surrounding Laboratory Biomarker Analysis?
"The origins of Laboratory Biomarker Analysis date back to 1997 at Spectrum Health Hospital - Butterworth Campus. In the 23 years since its inception, there have been 3228 completed clinical trials. At present, 2068 studies are ongoing; a significant portion of these in Los Angeles."
Answered by AI
Are there many sites participating in this trial in the city?
"The list of sites for this clinical trial includes Kaiser Permanente-Cadillac in Los Angeles, California, Allegiance Health in Jackson, Michigan, and Michigan Breast Specialists-Grosse Pointe Woods in Grosse Pointe Woods, Minnesota. There are also 100 other potential locations for the study."
Answered by AI
Is Laboratory Biomarker Analysis a reliable method?
"There is some evidence to support the efficacy of Laboratory Biomarker Analysis and it has undergone multiple rounds of safety testing, so our team at Power estimates its safety to be a 3."
Answered by AI
Is this an innovative or new study?
"Laboratory Biomarker Analysis has been researched for over two decades, with the first study being sponsored by Alfacell in 1997. 300 people were involved in the initial research project. After Phase 3 approval was granted, the number of active studies ballooned to 2068 spanning 3816 cities and 86 countries."
Answered by AI
Who else is applying?
What state do they live in?
Washington
California
Iowa
How old are they?
18 - 65
What site did they apply to?
University of Iowa Healthcare Cancer Services Quad Cities
Lafayette Family Cancer Center-EMMC
MedStar Good Samaritan Hospital
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
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