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Carboplatin and Paclitaxel with or without Panitumumab in Treating Patients with Invasive Triple Negative Breast Cancer

Status
Active
Cancer Type
Breast Cancer
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT02876107
Protocol IDs
2016-0177 (primary)
NCI-2017-00619
Study Sponsor
M D Anderson Cancer Center

Summary

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.

Objectives

PRIMARY OBJECTIVE:
I. To determine the pathologic complete response (pCR) rate in patients with primary triple-receptor negative (estrogen receptor [ER]-negative, progesterone receptor [PgR]-negative, and human epidermal growth factor receptor 2 [HER2]-negative) inflammatory breast cancer (TN-IBC) by using a combination of panitumumab, carboplatin, and paclitaxel (PaCT) in comparison with carboplatin and paclitaxel (CT) followed by adriamycin and cyclophosphamide (AC) in a neoadjuvant setting.

SECONDARY OBJECTIVES:
I. To determine the disease-free survival (DFS) rates produced by either arm of trial combination treatment.
II. To determine the overall survival (OS) rates produced by either arm of trial combination treatment.
III. To determine the safety and tolerability of both arms of trial combination treatment.

EXPLORATORY OBJECTIVES:
I. To determine whether the pCR rate positively correlates with reduced nodal expression status.
II. To determine whether the pCR rate inversely correlates with arginine methylation status of epidermal growth factor receptor (EGFR).
III. To identify molecular biomarkers predictive of the pCR rate by analysis of multiplexed immunohistochemical (IHC) staining.
IV. To identify molecular biomarkers predictive of the pCR rate by genomic and proteomic analysis.
V. To determine whether the inhibition of the EGFR pathway downregulates the COX-2 pathway and mesenchymal marker.
VI. To identify cell types in tumor microenvironment that determine the response topanitumumab by single cell ribonucleic acid (RNA) sequencing.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP A: Patients receive panitumumab intravenously (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. Patients then receive standard of care doxorubicin IV over 90 minutes and cyclophosphamide IV over 90 minutes on day 1 of cycles 5-8. Treatment repeats every 21 days for up to 4 cycles (cycles 1-4) and then every 14-21 days for up to 4 cycles (cycles 5-8) in the absence of disease progression or unexpected toxicity.

GROUP B: Patients receive paclitaxel, carboplatin, doxorubicin, and cyclophosphamide as in Group A. Treatment repeats every 21 days for up to 4 cycles (cycles 1-4) and then every 14-21 days for up to 4 cycles (cycles 5-8) in the absence of disease progression or unexpected toxicity.

After completion of study treatment, patients are followed up at 1 month and then annually for at least 5 years.

Eligibility

  1. Patients must have histological confirmation of breast carcinoma
  2. Patients must have invasive breast cancer (IBC), confirmed according to international consensus criteria: * Onset: Rapid onset of breast erythema, edema, and/or peau d’orange, and/or warm breast, with or without an underlying breast mass * Duration: History of such findings no more than 6 months * Extent: Erythema occupying at least 1/3 of whole breast * Pathology: Pathologic confirmation of invasive carcinoma
  3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  4. Patients must have negative HER2 expression on immunohistochemistry (IHC) (defined as 0 or 1+) or fluorescence in situ hybridization (FISH) analysis; if HER2 is 2+, negative HER2 expression must be confirmed by FISH (HER2/cep17 ration < 2, and/or copy number less than 6); ER and PgR expression should be less than 10% and PgR expression should be less than 20%
  5. Patients have left ventricular ejection fraction (LVEF) >= 50% by multigated acquisition scan (MUGA) or echocardiogram before study randomization
  6. Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
  7. Platelet count >= 100 x 10^9/L
  8. Hemoglobin >= 9.0 g/dL
  9. Aspartate aminotransferase (AST) =< 3.0 x upper limit of normal (ULN)
  10. Alanine aminotransferase (ALT) =< 3.0 x ULN
  11. Alkaline phosphatase (ALP) =< 2.5 x ULN
  12. Total bilirubin =< 1.5 x ULN
  13. Creatinine (Cr) =< 1.5 mg/dL x ULN
  14. Creatinine clearance (CrCl) >= 50 mL/min calculated by the Cockroft-Gault
  15. Patients have the ability and willingness to sign written informed consent
  16. Patients of childbearing potential (women who are postmenopausal for < 1 year, not surgically sterilized, or not abstinent), have a negative urine pregnancy test, and agree to the consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile before the female subject’s entry into the study and is the sole sexual partner for that female subject; intrauterine device, oral contraception, or barrier methods, including diaphragm or condom with a spermicide
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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