Trials / Withdrawn

WithdrawnNCT05177796

Panitumumab and Pembrolizumab in Combination With Neoadjuvant Chemotherapy for the Treatment of Stage III-IV Triple Negative Breast Cancer

Enhancing Immunotherapy by Targeting the EGFR Pathway in Inflammatory Breast Cancer: A Phase II Study of Panitumumab (PmAb) and Pembrolizumab (Pembro) in Combination With Neoadjuvant Chemotherapy (NAC) in Patients With Newly Diagnosed Triple Negative Inflammatory Breast Cancer (TN-IBC)

Status: Withdrawn
Phase: Phase 2
Study type: Interventional
Enrollment: 0 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase II trial tests whether panitumumab and pembrolizumab in combination with standard of care chemotherapy before surgery (neoadjuvant) works to shrink tumors in patients with stage III-IV triple negative breast cancer. Panitumumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving panitumumab and pembrolizumab in combination with neoadjuvant chemotherapy may kill more tumor cells in patients with triple negative breast cancer.

Detailed description

PRIMARY OBJECTIVE: I. To determine the pathological complete response (pCR rate) of the proposed combination in patients with newly diagnosed triple-negative inflammatory breast cancer (TN-IBC). SECONDARY OBJECTIVES I. To evaluate the surgical complication rate after the completion of the proposed treatment. II. To determine the change of EGR1 related to the efficacy of proposed treatment. (Key Secondary Objective) III. To determine the immunological change of tumor microenvironment (TME) related to the efficacy of proposed treatment. (Key Secondary Objective) IV. To define the cutoff or threshold of changes of EGR1, which will correlate with the pCR. V. To define the cutoff or threshold of immunological changes of TME, which will correlate with the pCR. VI. To determine two-year recurrence-free survival (RFS) rates. VII. To determine two-year overall survival (OS) rates. VIII. To determine the safety and tolerability. IX. To determine the predictive biomarkers to predict the therapeutic response. (correlative study) OUTLINE: CYCLES 1-4: Patients receive pembrolizumab intravenously (IV) over 30 minutes and panitumumab IV over 30-60 minutes on day 1 of cycle 0. Cycle 0 continues for 7 days in the absence of disease progression or unacceptable toxicity. Patients then receive panitumumab IV over 30-60 minutes on days 1, 8, and 15 of cycles 1-3 and days 1 and 8 of cycle 4, pembrolizumab IV over 30 minutes on day 1 of cycles 2-4, 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, 8 and 15 of cycles 1-4. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. CYCLES 5-8: Patients receive standard of care treatment, including pembrolizumab IV over 30 minutes, doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 and 90 days, then every 6 months for 2 years from date of surgery.

Conditions

Interventions

Type	Name	Description
DRUG	Carboplatin	Given IV
DRUG	Cyclophosphamide	Given IV
DRUG	Doxorubicin	Given IV
DRUG	Paclitaxel	Given IV
BIOLOGICAL	Panitumumab	Given IV
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

Start date: 2022-03-11
Primary completion: 2023-07-26
Completion: 2023-07-26
First posted: 2022-01-05
Last updated: 2024-10-24

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05177796. Inclusion in this directory is not an endorsement.