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

42 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug combination of chemotherapy and panitumumab for treating triple-negative breast cancer?

Research shows that adding carboplatin to standard chemotherapy can benefit some patients with triple-negative breast cancer. Additionally, panitumumab, when combined with other drugs like gemcitabine and carboplatin, has been studied for its effectiveness in treating this type of cancer, as it targets a protein often found in these tumors. ^{1 2 3 4 5}

What safety data exists for chemotherapy and Panitumumab in treating triple-negative breast cancer?

Nab-paclitaxel, a form of paclitaxel, has shown improved tolerability compared to standard paclitaxel. Carboplatin, when combined with other drugs, has shown good tolerability in other cancers. These findings suggest that these drugs are generally safe for use in humans, though specific safety data for Panitumumab in this context is not provided. ^{2 6 7 8 9}

What makes the drug combination of chemotherapy and panitumumab unique for treating triple-negative breast cancer?

This treatment is unique because it combines chemotherapy with panitumumab, an inhibitor of the epidermal growth factor receptor (EGFR), which is often overexpressed in triple-negative breast cancer. This approach aims to target specific pathways involved in cancer growth, potentially improving outcomes compared to standard chemotherapy alone. ^{1 5 10 11 12}

What is the purpose of this trial?

This randomized phase II trial studies how well carboplatin and paclitaxel with or without panitumumab work in treating patients with invasive triple negative breast cancer. Drugs used in the chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping the them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Giving carboplatin and paclitaxel with or without panitumumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Research Team

Azadeh Nasrazadani

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Panitumumab, Gemcitabine, and Carboplatin as Treatment for Women With Metastatic Triple-Negative Breast Cancer: A Sarah Cannon Research Institute Phase II Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Nab-paclitaxel/bevacizumab/carboplatin chemotherapy in first-line triple negative metastatic breast cancer. [2015]

3. England pubmed.ncbi.nlm.nih.gov

First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Phase II/III weekly nab-paclitaxel plus gemcitabine or carboplatin versus gemcitabine/carboplatin as first-line treatment of patients with metastatic triple-negative breast cancer (the tnAcity study): study protocol for a randomized controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Association of Immunophenotype With Pathologic Complete Response to Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: A Secondary Analysis of the BrighTNess Phase 3 Randomized Clinical Trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Immunotherapy for the Treatment of Triple-Negative Breast Cancer. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Atezolizumab-induced hemolytic anemia - A case report. [2021]

8. England 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. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Ixazomib in combination with carboplatin in pretreated women with advanced triple-negative breast cancer, a phase I/II trial of the AGMT (AGMT MBC-10 trial). [2019]

10. United States pubmed.ncbi.nlm.nih.gov

A phase II clinical trial of weekly paclitaxel and carboplatin in combination with panitumumab in metastatic triple negative breast cancer. [2020]

11. England pubmed.ncbi.nlm.nih.gov

How I treat metastatic triple-negative breast cancer. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Multicentric neoadjuvant phase II study of panitumumab combined with an anthracycline/taxane-based chemotherapy in operable triple-negative breast cancer: identification of biologically defined signatures predicting treatment impact. [2022]