Chemotherapy for Triple Negative Breast Cancer

Not currently recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Disqualifiers: Hepatitis B, Hepatitis C, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of two chemotherapy drugs, carboplatin (also known as Paraplatin or Carboplatinum) and nab-paclitaxel, when administered before surgery for locally advanced or inflammatory triple-negative breast cancer. These drugs stop cancer cells from growing and spreading, potentially shrinking tumors and simplifying surgery. Individuals diagnosed with this specific type of breast cancer who have not yet received treatment may be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since no prior therapies are allowed for the treatment of the newly diagnosed breast cancer, it's possible that you may need to stop certain medications. Please consult with the trial investigators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that carboplatin and nab-paclitaxel can effectively treat certain types of breast cancer. Studies have found these drugs to be generally well-tolerated by patients. Specifically, one study found that combining nab-paclitaxel with carboplatin was effective and manageable for individuals with breast cancer, including HER2+ MBC.

While side effects can occur, they are often manageable. Common side effects include fatigue, nausea, or low blood counts, but many patients manage these with support from their healthcare team. These drugs are already used in other cancer treatments, which can reassure their safety. Prospective trial participants should discuss potential side effects with a doctor, who can explain what to expect and how to address any issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using carboplatin and paclitaxel albumin-stabilized nanoparticle formulation for triple negative breast cancer because this combination offers a fresh approach to tackling aggressive tumors. Unlike standard treatments, which often involve traditional chemotherapy drugs, this therapy uses nab-paclitaxel, a nanoparticle formulation that potentially enhances drug delivery directly to the cancer cells, improving effectiveness while potentially reducing side effects. Additionally, the inclusion of carboplatin, a platinum-based drug, is thought to enhance the treatment's impact by causing DNA damage in cancer cells, making it harder for them to survive and multiply. This combination is particularly promising for patients who have limited options with conventional therapies.

What evidence suggests that this treatment might be an effective treatment for triple negative breast cancer?

Research has shown that using carboplatin and nab-paclitaxel together before surgery can help treat triple-negative breast cancer. This trial will evaluate the combination of carboplatin and nab-paclitaxel, which has shown promise in shrinking tumors and making them easier to remove. Studies have found that nab-paclitaxel, when used alone, works better and is safer than its traditional form. Evidence also indicates that carboplatin is effective against triple-negative breast cancer. Early findings suggest this treatment might be especially helpful for patients with advanced stages of the disease. ^{2 3 4 6 7}

Who Is on the Research Team?

Joanne Mortimer, MD, PhD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment

My breast cancer is advanced but not spread to distant parts, and it's triple negative.

Exclusion Criteria

Pregnancy

Subjects will be excluded who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Any other intercurrent medical/psychological problem deemed exclusionary by the treating physician or investigators/primary investigator (PI)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive carboplatin and nab-paclitaxel intravenously. Treatment repeats every 28 days for 4 courses.

16 weeks

Weekly visits for chemotherapy administration

Surgery

Participants undergo surgery after completion of neoadjuvant chemotherapy.

Up to 6 months from initial treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

Up to 5 years

Every 3 months for 4 years, then every 6 months for 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (carboplatin and nab-paclitaxel) Experimental Treatment 3 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.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 40 patients with stage III/IV squamous non-small-cell lung cancer, the combination of nab-paclitaxel and a platinum agent (cisplatin or carboplatin) resulted in a high overall response rate of 62.5% and a disease control rate of 92.5%, indicating its efficacy as a first-line treatment.

The treatment was generally well-tolerated, with most adverse effects being mild to moderate (grade 1 to 2), including myelosuppression and gastrointestinal issues, suggesting that nab-paclitaxel combined with platinum agents is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical investigation of efficacy of albumin bound paclitaxel plus platinum compounds as first-line chemotherapy for stage III/IV squamous non-small cell lung cancer. Fang, Y., Wang, L., Xia, GH., et al.[2022]

In a study of patients with advanced non-small cell lung cancer receiving carboplatin and nanoparticle albumin-bound paclitaxel, 55% experienced treatment suspension, primarily due to neutropenia (65.2%) and infections (24.2%).

Baseline liver dysfunction, age 65 or older, and a performance status of 2 were identified as significant risk factors for treatment suspension, highlighting the need for careful monitoring in these patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of risk factors associated with carboplatin and nab-paclitaxel treatment suspension in patients with non-small cell lung cancer. Saito, Y., Takekuma, Y., Shinagawa, N., et al.[2022]

In a clinical trial involving 90 patients with triple negative breast cancer (TNBC), the optimal chemotherapy regimen combined carboplatin with standard dose-dense ACT, resulting in the lowest grade 3 or 4 toxicities and no delays or dose reductions for carboplatin.

The study identified reduced protein levels of androgen receptor and PD-L1 as potential indicators of treatment response, with Stage I patients showing a zero relapse rate, suggesting the effectiveness of the carboplatin-based regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective phase II clinical trial identifying the optimal regimen for carboplatin plus standard backbone of anthracycline and taxane-based chemotherapy in triple negative breast cancer. Hamm, C., Fifield, BA., Kay, A., et al.[2022]

In a phase 3 trial involving 902 patients with untreated metastatic triple-negative breast cancer, the combination of atezolizumab and nab-paclitaxel significantly improved progression-free survival compared to nab-paclitaxel alone, with median survival times of 7.2 months versus 5.5 months, respectively.

The combination therapy also showed promising overall survival results, particularly in patients with PD-L1-positive tumors, where median overall survival was 25.0 months for the combination versus 15.5 months for the placebo group, indicating enhanced efficacy without new safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. Schmid, P., Adams, S., Rugo, HS., et al.[2021]

In a study of 190 patients with stage I-III triple-negative breast cancer (TNBC), the neoadjuvant regimen of carboplatin and docetaxel (CbD) achieved a high pathologic complete response (pCR) rate of 55%, indicating effective tumor reduction before surgery.

The CbD regimen was well tolerated, with only 21% of patients experiencing grade 3 or 4 adverse events, suggesting it is a safe treatment option comparable to traditional chemotherapy combinations that include anthracyclines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Neoadjuvant Carboplatin plus Docetaxel in Triple-Negative Breast Cancer: Combined Analysis of Two Cohorts. Sharma, P., López-Tarruella, S., García-Saenz, JA., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01525966

Study Details | NCT01525966 | Carboplatin and Paclitaxel ... This phase II trial studies how well carboplatin and nab-paclitaxel before surgery work in treating patients with triple negative breast cancer that is ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01525966?term=AREA%5BConditionSearch%5D(%22Breast%20Disease%22)%20AND%20AREA%5BInterventionSearch%5D(%22albumin-bound%20paclitaxel%22)&rank=10

Study Details | Carboplatin and Paclitaxel Albumin- ... A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4362893/

Phase II trial of weekly nab-paclitaxel and carboplatin ... A trend suggesting that nab-paclitaxel was beneficial for clinical tumor stage II and triple-negative breast cancer was observed. ... carboplatin is an effective ...

4. withpower.com withpower.com/trial/chemotherapy-for-triple-negative-breast-cancer-5a8b1

Chemotherapy for Triple Negative Breast Cancer This phase II trial studies how well carboplatin and nab-paclitaxel before surgery work in treating patients with triple negative breast cancer that is ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0960977611001305

Management of breast cancer with nanoparticle albumin- ... Monotherapy with nanoparticle albumin-bound (nab)-paclitaxel has demonstrated improved efficacy and safety compared with solvent-based paclitaxel and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01525966

Study Details | NCT01525966 | Carboplatin and Paclitaxel ... This phase II trial studies how well carboplatin and nab-paclitaxel before surgery work in treating patients with triple negative breast cancer that is ...

7. ascopubs.org ascopubs.org/doi/10.1200/jco.2008.26.15_suppl.1047

Phase II study of weekly nanoparticle albumin bound (nab) ... Weekly P+Cb+T is active and well-tolerated in patients (pts) with HER2+ MBC (Perez E, Clin Breast Cancer 2005). Nab-P is more active than Cremophor-based P ( ...