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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
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Residual Cancer Burden (RCB) by Symmans Criteria.
pCR Rate After Treatment.
Secondary study objectives
Adjuvant Radiation
Overall Survival
Progression-free Survival
+1 moreSide effects data
From 2024 Phase 2 trial • 62 Patients • NCT0225865997%
Fatigue
90%
Mucositis oral
90%
Nausea
84%
Dysgeusia
82%
Constipation
77%
Anorexia
73%
Dermatitis radiation
71%
Dry mouth
58%
Neutrophil count decreased
58%
Platelet count decreased
50%
Peripheral sensory neuropathy
48%
Diarrhea
40%
Weight loss
39%
Anemia
39%
Vomiting
34%
Oral pain
31%
Fever
31%
Pain
29%
Dysphagia
27%
Pruritus
26%
Cough
24%
Palmar-plantar erythrodysesthesia syndrome
24%
Epistaxis
23%
White blood cell decreased
21%
Alanine aminotransferase increased
21%
Pharyngolaryngeal pain
19%
Anxiety
18%
Edema limbs
18%
Abdominal pain
16%
Insomnia
16%
Esophageal pain
15%
Aspartate aminotransferase increased
15%
Headache
15%
Lymphedema
15%
Nasal congestion
13%
Bone pain
13%
Myalgia
11%
Skin ulceration
10%
Sore throat
10%
Gastroesophageal reflux disease
10%
Alopecia
10%
Mucosal infection
10%
Thromboembolic event
8%
Hoarseness
8%
Dizziness
8%
Pain in extremity
8%
Skin and subcutaneous tissue disorder
6%
Atrial fibrillation
6%
Blurred vision
6%
Hypokalemia
6%
Injury, poisoning and procedural complication
6%
Acute kidney injury
6%
Ear pain
6%
Eye disorders - Other, specify
6%
Neck edema
6%
Postnasal drip
2%
Aspiration
2%
Productive cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Awards & Highlights
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.
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
599 Previous Clinical Trials
1,923,475 Total Patients Enrolled
42 Trials studying Breast Cancer
4,877 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,011,961 Total Patients Enrolled
942 Trials studying Breast Cancer
1,443,183 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.
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