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Neoadjuvant Trial of Nab-Paclitaxel and MPDL3280A

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: MPDL3280A (Drug); Nab-paclitaxel (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Jennifer Litton, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Jennifer Litton, MD, Phone: 713-792-2817

Summary

The goal of this clinical research study is to learn if receiving MPDL3280A and abraxane (nab-paclitaxel) in combination before surgery and MPDL3280A alone after surgery can help to control breast cancer. The safety of this study drug combination will also be studied.

Clinical Details

Official title: Triple-Negative First-Line Study: Neoadjuvant Trial of Nab-Paclitaxel and MPDL3280A, a Pdl-1 Inhibitor in Patients With Triple Negative Breast Cancer

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pathologic Complete Response (pCR) of MPDL3280A in Combination with Nab-paclitaxel

Secondary outcome: Progression Free Survival (PFS)

Detailed description: Study Drug Administration: Each study cycle is 21 days. You will receive the study drugs in 2 sets of 4 cycles (4 cycles before surgery and 4 cycles after surgery). You will receive MPDL3280A by vein over about 30 minutes on Day 1 of each cycle before and after surgery. You will receive nab-paclitaxel by vein over about 30 minutes on Day 1 of Cycles 1-4 before surgery. If you have side effects, the study doctor may decide to lower your dose of study drugs or have you stop taking the drugs. You may be able to restart the study drug later at the same or a lower dose. The study doctor will discuss this with you. Study Visits: On Day 1 of all cycles:

- You will have a physical exam.

- Blood (about 2 tablespoons) will be drawn for routine tests.

- During Cycle 3, you will have an ultrasound of your breast(s) before surgery.

- During Cycle 3, blood (about 1 tablespoon each time) will be drawn before surgery and

at the time of surgery. Within 6 weeks after you have received 4 cycles of study drugs, you will have surgery as part of your standard of care and part of the tumor tissue that is removed during surgery will be collected for biomarker testing. You will be given a surgery consent form that describes the procedure and its risks. On Day 21 of Cycle 8, blood (about 1 tablespoon) will be drawn for biomarker testing. Length of Treatment: You may receive the study drugs for about 4 cycles before your surgery and about 4 cycles after your surgery (8 cycles total). You will no longer be able to take the study drug, if intolerable side effects occur, or if you are unable to follow study directions. You may be able to continue taking the study drugs if the disease gets worse if the doctor thinks it is in your best interest. Your participation on the study will be over after follow-up. Follow-Up: Every 6 months for up to 3 years, you will either have a clinic visit or you will be called by a member of the study staff and asked how you are doing. If you are called, each call should last about 15-20 minutes. This is an investigational study. MPDL3280A is not FDA approved or commercially available. It is currently being used for research purposes only. Nab-paclitaxel is FDA approved and commercially available for the treatment of metastatic (has spread) breast cancer. The study doctor can explain how the study drug combination is designed to work. Up to 37 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Signed written informed consent 2. Histologically confirmed primary invasive adenocarcinoma of the breast with the size of the primary tumor being at least 1. 5 cm on imaging by either mammography, ultrasound or breast MRI 3. ER and PR expression both <10% by immunohistochemistry (IHC) and HER2 0 or 1+ by IHC or non-amplified HER2 expression as determined by Fluorescence In Situ Hybridization (FISH) 4. No prior treatment for primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy or surgery other than the anthracycline and cyclophosphamide chemotherapy with or without 5-fluorouracil given as part of participation in protocol 2014-0185. Treatment for ductal carcinoma in situ is allowed, such as surgery, hormonal therapy and radiotherapy 5. ECOG performance status of 0-1 6. Baseline MUGA or echocardiogram scans with LVEF of > 50% 7. Patient must have adequate organ function as determined by the following laboratory values: ANC >/= 1500 cells/uL, WBC counts > 2500/uL, Lymphocyte count >/= 300/uL, Platelet count >/=100,000/uL; Hemoglobin >/= 9. 0 g/dL, Total bilirubin /= 50 mL/min on the basis of

the Cockcroft-Gault glomerular filtration rate estimation: (140 - age) x (weight in

kg) x (0. 85 if female)/ 72 x (serum creatinine in mg/dL), INR and aPTT class II), unstable angina, or unstable cardiac arrhythmia requiring medication 8. Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy 9. Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocols 10. History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis. Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible. 11. Continued from #9: Patients with eczema, psoriasis, lichen simplex chronicum of vitiligo with dermatologic manifestations only (e. g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations Rash must cover less than 10% of body surface area (BSA) Disease is well controlled at baseline and only requiring low potency topical steroids (e. g., hydrocortisone 2. 5%, hydrocortisone butyrate 0. 1%, fluocinolone 0. 01%, desonide 0. 05%, alclometasone dipropionate 0. 05%) No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids) 12. Known to be human immunodeficiency virus positive 13. Patients with prior allogeneic stem cell or solid organ transplantation 14. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i. e., bronchiolitis obliterates, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted 15. Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA 16. Active tuberculosis 17. Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live, attenuated vaccine will be required during the study. Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine (e. g., FluMist) within 4 weeks prior to Cycle 1, Day 1 or at any time during the study 18. Treatment with systemic immunostimulatory agents (including but not limited to interferons or IL-2) within 4 weeks or five half-lives of the drug, whichever is shorter 19. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents), or anticipated requirement for systemic immunosuppressive medications during the trial. Patients who have received acute, low dose, systemic immunosuppressant medications (e. g., dexamethasone prior to the anthracycline-based chemotherapy for nausea) may be enrolled in the study. The use of inhaled corticosteroids and mineralocorticoids (e. g., fludrocortisone) is allowed 20. Concurrent disease or condition that would interfere with study participation or safety, such as any of the following: Active, clinically significant infection either grade > 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4. 03 or requiring the use of parenteral anti-microbial agents within 14 days before Day 1 of study drug, Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders, Non-healing wound, ulcer, or bone fracture 21. Known hypersensitivity to any of the components of MPDL3280A or nab-paclitaxel 22. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

Locations and Contacts

Jennifer Litton, MD, Phone: 713-792-2817

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Not yet recruiting
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: December 2015
Last updated: August 19, 2015

Page last updated: August 23, 2015

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