Chemotherapy +/− Panitumumab for Triple Negative Breast Cancer

Overseen By Naoto Ueno, MD, PHD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Stage IV cancer, Recent malignancies, 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: 22

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of adding panitumumab, an antibody that may inhibit cancer cell growth, to standard chemotherapy for patients with invasive triple-negative breast cancer. The study compares two groups: one receiving chemotherapy drugs carboplatin and paclitaxel with panitumumab, and another receiving only the chemotherapy drugs. It aims to determine if including panitumumab before surgery can shrink the tumor more effectively, potentially preserving more healthy tissue. Individuals with a confirmed diagnosis of invasive breast cancer showing rapid changes such as redness, swelling, or warmth in at least a third of the breast within the past six months may qualify. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant advancements in cancer therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that the treatments in this trial have been safe in other studies. Panitumumab has been well-tolerated with chemotherapy in some studies, but it remains experimental for treating triple-negative breast cancer. In other cancers, patients generally handle it well, though it can have side effects like any medication.

Paclitaxel, a chemotherapy drug, is commonly used for various cancers, including breast cancer. Studies indicate it is effective and usually well-tolerated. However, combining it with certain other drugs can increase side effects, so monitoring patient responses is important.

Carboplatin is another chemotherapy drug widely used and known to improve breast cancer outcomes when added to other treatments. It has a manageable safety profile, meaning doctors can monitor and manage the known side effects.

Overall, these treatments have been successful in various studies, but the combination being tested here is still under study to ensure safety for everyone. Participants will be closely monitored for any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for triple-negative breast cancer because they explore the potential benefits of adding panitumumab to the usual chemotherapy regimen. Panitumumab is a monoclonal antibody that targets a protein called EGFR, which is often overexpressed in cancer cells. This targeted approach is different from standard chemotherapies like paclitaxel and carboplatin, which attack all rapidly dividing cells. By combining panitumumab with traditional chemotherapy, there's hope for a more effective treatment that specifically targets cancer cells, possibly leading to better outcomes for patients.

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

Research has shown that using carboplatin and paclitaxel, with or without panitumumab, may help treat triple-negative breast cancer. In this trial, participants in Group A will receive carboplatin, paclitaxel, and panitumumab. Studies suggest that adding panitumumab, a medicine targeting cancer cells, can increase the chances of tumors completely disappearing before surgery. Specifically, one study found that 42% of patients with this type of breast cancer had a complete response when panitumumab was included. Participants in Group B will receive only carboplatin and paclitaxel, which has also proven effective in helping patients live longer. This trial studies both treatment methods for their ability to shrink tumors and improve patient outcomes. ^{5 6 7 8 9}

Who Is on the Research Team?

Azadeh Nasrazadani

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with invasive triple negative breast cancer who haven't had certain treatments like carboplatin or radiotherapy for their condition. They should have good organ function, no serious heart issues, and not be dealing with other major medical or psychiatric conditions that could affect the study. Women of childbearing age must test negative for pregnancy and agree to use birth control.

Inclusion Criteria

My breast cancer has been confirmed by a tissue examination.

My cancer does not show HER2 activity based on specific tests.

My heart pumps well, with an ejection fraction of 50% or higher.

Exclusion Criteria

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

I haven't had any cancer except for skin cancer or cervical cancer in the last 5 years.

You have tested positive for HIV, hepatitis C, or have active hepatitis B infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive panitumumab, paclitaxel, and carboplatin or paclitaxel, carboplatin, doxorubicin, and cyclophosphamide in cycles every 21 days for up to 8 cycles

24 weeks

Visits every 21 days for up to 8 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

1 visit at 1 month post-treatment, then annually

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Paclitaxel
• Panitumumab

Trial Overview

The trial is testing how well a combination of chemotherapy drugs (carboplatin and paclitaxel) works when given alone versus when combined with panitumumab, a monoclonal antibody. The goal is to see if adding panitumumab can better shrink tumors before surgery in patients with this type of breast cancer.

How Is the Trial Designed?

Group I: Group B (paclitaxel, carboplatin) Experimental Treatment 3 Interventions

Patients receive paclitaxel, carboplatin, doxorubicin, and cyclophosphamide as in Group A. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unexpected toxicity.

Group II: Group A (panitumumab, paclitaxel, carboplatin) Experimental Treatment 4 Interventions

Patients receive panitumumab IV over 1 hour on day 1 of cycle 0 and over 30 minutes on days 1, 8, and 15 of cycles 1-4. Patients also receive paclitaxel IV over 1-3 hours on days 1, 8, and 15 of cycles 1-4, and carboplatin IV over 30 minutes on day 1 of cycles 1-4. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unexpected 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?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Atezolizumab, when used with nab-paclitaxel for treating triple negative breast cancer, can cause rare side effects like autoimmune hemolytic anemia, as seen in a case study of a 59-year-old female patient.

The patient's hemolytic anemia was effectively managed with a high-dose prednisone taper, allowing her to continue her cancer treatment without further complications through multiple cycles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab-induced hemolytic anemia - A case report. Younce, CM., Lawton, JM., Patel, DR.[2021]

DZ-2384, a new microtubule-targeting agent, shows strong effectiveness against triple-negative breast cancer (TNBC) in preclinical models, outperforming traditional taxanes like paclitaxel in terms of reduced toxicity and a wider therapeutic window (14-32 compared to 2.0 for paclitaxel).

DZ-2384 not only effectively reduces brain metastatic lesions but also works synergistically with anti-CTLA-4 immunotherapy, suggesting it could enhance treatment outcomes when combined with immune checkpoint inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DZ-2384 has a superior preclinical profile to taxanes for the treatment of triple-negative breast cancer and is synergistic with anti-CTLA-4 immunotherapy. Bernier, C., Soliman, A., Gravel, M., et al.[2019]

Citations

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sciencedirect.com

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Association between neoadjuvant paclitaxel dose intensity ...

Association between neoadjuvant paclitaxel dose intensity and outcomes in early triple-negative and HER2-positive breast cancer: a real-world data analysis.

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A Phase III Randomized Controlled Trial

Carboplatin did not significantly increase EFS but significantly increased the OS in patients with TNBC, with benefits confined to premenopausal ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT01207102

Study Of Abraxane® And Carboplatin As First-Line ...

This study combines these two agents: primarily, to evaluate progression-free survival; and secondarily, to assess the feasibility and tolerability of this ...

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pubmed.ncbi.nlm.nih.gov/35093516/

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sciencedirect.com

sciencedirect.com/science/article/pii/S0923753422000187

Long-term efficacy and safety of addition of carboplatin with ...

At 4.5 years, adding carboplatin to neoadjuvant paclitaxel followed by AC improved event-free survival in stage II-III TNBC. •. Adding veliparib to carboplatin- ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12057025/

The impact of carboplatin on pathologic complete response ...

It is known that adding carboplatin to NACT increases the complete response rate and positively affects DFS and OS in TNBC patients [7, 8]. The ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02531932

NCT02531932 | Comparison of Single-Agent Carboplatin ...

The purpose of this study is to evaluate the safety and effectiveness of carboplatin compared to the combination of carboplatin and everolimus for the ...