Chemotherapy for Triple Negative Breast Cancer

Overseen By Clinical Trials Office

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Pregnancy, Metastatic disease, Heart failure, 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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for treating triple-negative breast cancer, which lacks certain common receptors. The treatment uses chemotherapy drugs—pegylated liposomal doxorubicin hydrochloride and carboplatin—before surgery to shrink the tumor, followed by paclitaxel after surgery to help prevent recurrence. Women with untreated stage II-III triple-negative breast cancer and no other serious health issues might be suitable for this trial. The researchers aim to determine if this combination of treatments can be more effective against this challenging cancer. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in cancer therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot receive other treatments for breast cancer while participating in this trial.

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

Research has shown that pegylated liposomal doxorubicin hydrochloride, a type of chemotherapy drug, is generally well-tolerated. Studies have found it to be safer than traditional forms of the drug. Most side effects are mild, such as tiredness and nausea, but about 14% of patients experience more serious issues.

Carboplatin, another chemotherapy drug, also has a manageable safety profile. It has been studied in patients with triple-negative breast cancer, and its side effects align with expectations for this type of drug.

Paclitaxel, also used in this trial, is a commonly used chemotherapy drug with a well-known safety profile. It is considered effective, but patients should be aware of possible side effects, which can range from mild to moderate.

These drugs are used together in the trial because they attack cancer cells in different ways. While they are generally safe, discussing any concerns with the trial team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment approach for triple-negative breast cancer because it combines pegylated liposomal doxorubicin hydrochloride with carboplatin in a unique regimen. Unlike traditional treatments that might focus only on surgery or different chemotherapy drugs, this combination leverages the enhanced delivery of doxorubicin in a liposomal form, potentially reducing side effects and improving drug concentration at the tumor site. Additionally, the use of paclitaxel in the adjuvant setting offers a comprehensive treatment strategy that aims to attack the cancer cells from multiple angles, possibly leading to better outcomes.

What evidence suggests that this trial's treatments could be effective for triple negative breast cancer?

In this trial, participants will receive a combination of treatments. Studies have shown that pegylated liposomal doxorubicin hydrochloride, a special form of the drug doxorubicin, effectively treats breast cancer. It functions like traditional doxorubicin but causes less heart damage. Research indicates that carboplatin, another treatment in this trial, can improve survival rates and reduce the chance of cancer recurrence in people with triple-negative breast cancer. Using carboplatin before surgery has been linked to better outcomes, such as more successful surgeries. Paclitaxel, another chemotherapy drug in this trial, has effectively improved treatment response in patients with triple-negative breast cancer. Together, these treatments have shown promise in stopping the growth and spread of cancer cells. ^{4 5 6 7 8}

Who Is on the Research Team?

Kim M. Hirshfield

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

This trial is for women with previously untreated stage II-III triple-negative breast cancer who are expected to live more than a year and can undergo surgery. They must have good performance status, satisfactory blood counts, normal heart function, and agree to use contraception. Excluded are those with certain cardiac conditions, serious disorders, inflammatory breast cancer, severe lung or nervous system issues, history of major organ transplant or need for immunosuppression.

Inclusion Criteria

I do not have any non-healing wounds or skin issues.

I have stage II-III breast cancer that is ER, PgR, and HER2 negative.

I am eligible for surgery to treat my breast cancer.

Exclusion Criteria

I have a heart condition.

My cancer has spread to other parts of my body.

I have been diagnosed with inflammatory breast cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Patients receive pegylated liposomal doxorubicin hydrochloride and carboplatin intravenously every 28 days for 4 courses

16 weeks

Surgery

Patients undergo definitive surgery at the discretion of the treating physician

Adjuvant Treatment

Patients receive paclitaxel intravenously once weekly for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 20 years

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Paclitaxel
• Pegylated Liposomal Doxorubicin Hydrochloride
• Therapeutic Conventional Surgery

Trial Overview

The study tests if pegylated liposomal doxorubicin hydrochloride and carboplatin chemotherapy before surgery followed by paclitaxel after surgery can effectively treat patients with triple-negative breast cancer. The treatment aims to shrink tumors pre-surgery and eliminate remaining cells post-surgery.

How Is the Trial Designed?

Group I: Treatment (doxil, carboplatin, surgery, paclitaxel) Experimental Treatment 7 Interventions

NEOADJUVANT: Patients receive pegylated liposomal doxorubicin hydrochloride\* IV over 90 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. ADJUVANT: Patients undergo definitive surgery at the discretion of the treating physician. Patients then receive paclitaxel IV over 60 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. \*NOTE: If there is a shortage of pegylated liposomal doxorubicin hydrochloride, patients receive epirubicin hydrochloride IV over 15-20 minutes on day 1.

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?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Rutgers Cancer Institute of New Jersey

Collaborator

Trials

72

Recruited

22,200+

Published Research Related to This Trial

In a phase II study involving 34 patients with metastatic breast cancer, the combination of paclitaxel and liposomal doxorubicin was effective in 73% of patients, showing a high response rate with 7 complete and 18 partial responses.

The treatment had a moderate toxicity profile, with only a small number of severe side effects reported, including 2 toxic deaths (6%), indicating that while effective, careful monitoring for serious adverse effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First line therapy with paclitaxel (Taxol) and pegylated liposomal doxorubicin (Caelyx) in patients with metastatic breast cancer: a multicentre phase II study. Vorobiof, DA., Rapoport, BL., Chasen, MR., et al.[2015]

The combination of non-pegylated liposomal doxorubicin and carboplatin showed a disease control rate of 30% at 12 months in 87 patients with platinum-sensitive recurrent ovarian cancer, indicating its potential efficacy as a treatment option.

The treatment had an acceptable safety profile, with significant side effects like grade 3-4 neutropenia occurring in 17% of patients, and the use of G-CSF support was associated with better outcomes, highlighting the importance of managing side effects in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-pegylated liposomal doxorubicin (NPLD, Myocet®) + carboplatin in patients with platinum sensitive ovarian cancers: A ARCAGY-GINECO phase IB-II trial. Romeo, C., Joly, F., Ray-Coquard, I., et al.[2019]

Pegylated liposomal doxorubicin (Caelyx®/Doxil®) is an improved formulation of conventional doxorubicin that significantly reduces cardiotoxicity and enhances pharmacokinetics.

Clinical trials demonstrate that pegylated liposomal doxorubicin is effective in treating several cancers, including metastatic breast cancer and ovarian cancer, while maintaining a favorable safety profile compared to traditional chemotherapy agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pegylated liposomal doxorubicin: a guide to its use in various malignancies. Lyseng-Williamson, KA., Duggan, ST., Keating, GM.[2018]

In a study of 81 late-relapsing advanced ovarian cancer patients, the combination of pegylated liposomal doxorubicin (PLD) and carboplatin resulted in a high objective response rate of 65.4%, indicating effective treatment.

The treatment was well-tolerated, with manageable side effects; most adverse reactions were hematological, and no cases of cardiotoxicity or treatment-related deaths were reported, supporting its safety as a second-line therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pegylated liposomal doxorubicin and carboplatin in late-relapsing ovarian cancer: a GINECO group phase II trial. Weber, B., Lortholary, A., Mayer, F., et al.[2018]

Pegylated liposomal doxorubicin (PLD) is an effective treatment for ovarian cancer that significantly reduces the risk of cardiotoxicity and other common side effects like nausea and hair loss, thanks to its unique formulation.

However, PLD is associated with dose-limiting cutaneous toxicities, including hand-foot syndrome, follicular rash, intertrigo-like eruptions, and hyperpigmentation, which are important considerations for patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pegylated liposomal doxorubicin (PLD): enhanced skin toxicity in areas of vitiligo. Yuan, Y., Orlow, SJ., Curtin, J., et al.[2022]

In a study of 162 patients with stages I-III Triple-negative breast cancer (TNBC), pegylated liposomal doxorubicin (PLD) showed similar overall survival (OS) and relapse-free survival (RFS) rates compared to conventional chemotherapy, indicating its efficacy as an alternative treatment.

PLD-based chemotherapy resulted in a lower incidence of severe neutropenia (25% vs. 41.6%) but a higher incidence of hand-foot syndrome (16.3% vs. 4.4%), suggesting a different safety profile compared to traditional anthracycline treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of pegylated liposomal doxorubicin-based adjuvant chemotherapy in patients with stage I-III triple-negative breast cancer. Lien, MY., Liu, LC., Wang, HC., et al.[2018]

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