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Alkylating agents
Chemotherapy for Triple Negative Breast Cancer
Phase 2
Waitlist Available
Led By Yuan Yuan, MD, PhD
Research Sponsored by City of Hope Medical Center
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 three years post-commencement of chemotherapy.
Awards & highlights
Study Summary
This trial is testing if giving carboplatin and nab-paclitaxel before surgery can help treat triple negative breast cancer.
Who is the study for?
This trial is for women with a specific breast cancer type called triple negative, which has spread locally or is inflammatory. They must have good heart function and normal liver tests, no prior treatments for this cancer, and agree to use contraception. It's not open to those with recent other cancers, certain infections like HIV or hepatitis B/C, neuropathy above grade 1, or if they can't follow the study rules.Check my eligibility
What is being tested?
The trial tests how well carboplatin and nab-paclitaxel chemotherapy work when given before surgery in shrinking tumors of patients with advanced triple negative breast cancer. The goal is to see if these drugs can reduce tumor size enough so less normal tissue needs removal during surgery.See study design
What are the potential side effects?
Carboplatin and nab-paclitaxel may cause side effects such as fatigue, hair loss, nausea, numbness in fingers or toes (neuropathy), low blood cell counts increasing infection risk and bleeding problems. Some side effects might be serious enough to stop treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to three years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to three years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Residual Cancer Burden (RCB) by Symmans Criteria.
pCR Rate After Treatment.
Secondary outcome measures
Adjuvant Radiation
Overall Survival
Progression-free Survival
+1 moreSide effects data
From 2010 Phase 2 trial • 76 Patients • NCT0040423590%
Hemoglobin decreased
90%
Fatigue
72%
Neutrophil count decreased
56%
Nausea
51%
Platelet count decreased
49%
Peripheral sensory neuropathy
33%
Myalgia
26%
Vomiting
26%
Joint pain
23%
Leukocyte count decreased
21%
Alopecia
13%
Constipation
10%
Lymphocyte count decreased
10%
Hypersensitivity
8%
Diarrhea
8%
Fever
5%
Dyspepsia
5%
Dehydration
5%
Anorexia
5%
Hyperglycemia
3%
Diplopia
3%
Creatinine increased
3%
Hearing loss
3%
Catheter related infection
3%
Colitis, infectious (e.g., Clostridium difficile)
3%
Skin infection
3%
Hypotension
3%
Abdominal distension
3%
Bladder infection
3%
Thrombosis
3%
Hemorrhage
3%
Proteinuria
3%
Back pain
3%
Neuralgia
3%
Hot flashes
3%
Urinary tract infection
3%
Edema limbs
3%
Hypocalcemia
3%
Neck pain
3%
Buttock pain
3%
Peripheral motor neuropathy
3%
Taste alteration
3%
Tumor pain
3%
Pain in extremity
3%
Headache
3%
Weight loss
3%
Ear, nose and throat examination abnormal
3%
Vaginal dryness
3%
Dyspnea
3%
Nasal congestion
3%
Febrile neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2 (Chemotherapy Naive, CN)
Cohort 1 (Prior Chemotherapy, PT)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (carboplatin and nab-paclitaxel)Experimental Treatment3 Interventions
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Carboplatin
FDA approved
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
568 Previous Clinical Trials
1,924,593 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,680 Previous Clinical Trials
40,928,452 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Yuan Yuan, MD, PhDPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
410 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your creatinine levels should be less than or equal to 1.5 mg/dL, but your hospital's normal range may also be accepted.My breast cancer is advanced but not spread to distant parts, and it's triple negative.Women who can become pregnant must have a negative pregnancy test.I have not received any treatment for my newly diagnosed breast cancer and had no taxanes or carboplatin for any past cancer treated over 5 years ago.Your AST and ALT levels should not be more than twice the upper limit of normal.Your heart is pumping blood normally.Your white blood cell count is at least 1,500 cells per cubic millimeter.My neuropathy is mild or I don't have it.My tumor does not show hormone receptors and is HER2 negative.Your platelet count is at least 100,000 cells per cubic millimeter.Your bilirubin level should be less than or equal to 1.5 mg/dL.I have an active HIV infection.I was treated for breast cancer or another cancer within the last 5 years.Your alkaline phosphatase level is not more than twice the upper normal limit.Your hemoglobin level is higher than 9.0 grams per deciliter.You have an ongoing hepatitis B or C infection.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (carboplatin and nab-paclitaxel)
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Has the paclitaxel albumin-stabilized nanoparticle formulation been given authorization by the FDA?
"The safety of paclitaxel albumin-stabilized nanoparticle formulation was rated a 2, as there is only evidence to suggest it is safe but not that it is effective in treating diseases."
Answered by AI
What types of maladies can be remedied by paclitaxel albumin-stabilized nanoparticle formulation?
"Paclitaxel albumin-stabilized nanoparticle formulation is a popular intervention for neoplasm metastasis. However, this advanced treatment modality has also been employed to address acute pyelonephritis (APN), lymphoma, non-Hodgkin's shock and hypovolemic conditions."
Answered by AI
Are there any vacancies for enrolment in this experiment?
"Per the clinicaltrials.gov records, this specific medical trial is not presently enrolling any participants. Having first been posted on February 15th 2012 and most recently edited on July 9th 2021, there are no longer openings available for applications; however, 3465 other trials have open spots right now."
Answered by AI
What is the total number of people participating in this experiment?
"This trial is no longer recruiting patients; it was initially posted on February 15th 2012 and its data most recently updated on July 9th 2021. For those looking for other studies, 2358 clinical trials are currently searching for individuals with Stage IIIA breast cancer while 1,107 separate medical experiments are bringing in participants to test paclitaxel albumin-stabilized nanoparticle formulation."
Answered by AI
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