Nab-Paclitaxel and Atezolizumab Before Surgery in Treating Patients With Triple Negative Breast Cancer

NCT02530489 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2014-1043NCI-2015-01537
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well nab-paclitaxel and atezolizumab before surgery work in treating patients with triple negative breast cancer (breast cancer cells that do not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 protein). Drugs used in chemotherapy, such as nab-paclitaxel, 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. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nab-paclitaxel and atezolizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. This drug combination before surgery may be an effective treatment for triple negative breast cancer.

Conditions

Breast Adenocarcinoma; Invasive Breast Carcinoma; Triple-Negative Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• RCB Status

  Residual Disease at the time of surgery

  at the time of surgery, up to 12 weeks

Study Arms (1)

Treatment (atezolizumab, nab-paclitaxel)

EXPERIMENTAL

NEOADJUVANT: Patients receive atezolizumab IV over 60 minutes on day 1 and nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. SURGERY: Patients undergo definitive breast surgery within 6 weeks of the completion of treatment. ADJUVANT: Within 4 weeks after surgery, patients receive atezolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

Drug: Atezolizumab; Drug: Nab-paclitaxel

Interventions

Atezolizumab DRUG

Given IV

Also known as: MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG7446, RO5541267, Tecentriq

Treatment (atezolizumab, nab-paclitaxel)

Nab-paclitaxel DRUG

Given IV

Also known as: ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Protein-bound Paclitaxel

Treatment (atezolizumab, nab-paclitaxel)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Histologically confirmed primary invasive adenocarcinoma of the breast with the size of the primary tumor being at least 1.5 cm, or at least 1 biopsy confirmed involved lymph node \> 1.5 cm, on imaging by either mammography, ultrasound or breast magnetic resonance imaging (MRI)
• Estrogen receptor (ER) and progesterone receptor (PR) expression both \< 10% by immunohistochemistry (IHC) and human epidermal growth factor receptor 2 (HER2) negative or non-amplified as determined by the current American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) criteria which are as follows: HER2 testing by IHC as 0 or 1+; if HER2 is 2+, ISH (in situ hybridization) must be performed; HER2 is positive for gene amplification if: - IHC 3+ based on circumferential membrane staining that is complete, intense - ISH positive based on:
• Single-probe average HER2 copy number \>= 6.0 signals/cell
• Dual-probe HER2/chromosome enumeration probe (CEP)17 ratio \>= 2.0; with an average HER2 copy number \>= 4.0 signals/cell
• Dual-probe HER2/CEP17 ratio \>= 2.0; with an average HER2 copy number \< 4.0 signals/cell
• Dual-probe HER2/CEP17 ratio \< 2.0; with an average HER2 copy number \>= 6.0 signals/cell
• 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; treatment for ductal carcinoma in situ is allowed, such as surgery, hormonal therapy and radiotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Baseline multi gated acquisition scan (MUGA) or echocardiogram scans with left ventricular ejection fraction (LVEF) of \> 50%
• Absolute neutrophil count (ANC) \>= 1500 cells/uL
• White blood cell counts (WBC) \> 2500/uL
• Lymphocyte count \>= 300/uL
• Platelet count \>= 100,000/uL
• Hemoglobin \>= 9.0 g/dL

You may not qualify if:

• Women who are pregnant or breast-feeding
• Known metastatic disease
• Disease free of prior malignancy for \< 5 years with the exception of curatively treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, or transitional cell carcinoma
• Has received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), anti-programmed cell death ligand 2 (PD-L2), anti-cluster of differentiation (CD)137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
• Has had major surgery within 21 days before cycle 1, day 1
• Uncontrolled inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
• Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (New York Heart Association \> class II), unstable angina, or unstable cardiac arrhythmia requiring medication
• Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy
• Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocols
• 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, Sjogren syndrome, Bell's palsy, Guillain-Barre 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; patients with eczema, psoriasis, lichen simplex chronicus 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)
• Known to be human immunodeficiency virus positive
• Patients with prior allogeneic stem cell or solid organ transplantation
• History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted
• 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 ribonucleic acid (RNA)
• Active tuberculosis

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Yam C, Mittendorf EA, Garber HR, Sun R, Damodaran S, Murthy RK, Ramirez D, Karuturi M, Layman RM, Ibrahim N, Rauch GM, Adrada BE, Candelaria RP, White JB, Ravenberg E, Clayborn A, Ding QQ, Symmans WF, Prabhakaran S, Thompson AM, Valero V, Tripathy D, Huo L, Moulder SL, Litton JK. A phase II study of neoadjuvant atezolizumab and nab-paclitaxel in patients with anthracycline-resistant early-stage triple-negative breast cancer. Breast Cancer Res Treat. 2023 Jun;199(3):457-469. doi: 10.1007/s10549-023-06929-9. Epub 2023 Apr 15.

  PMID: 37061619 DERIVED

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

atezolizumab; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Taxes

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations

Results Point of Contact

• Title: Clinton Yam
• Organization: M.D. Anderson Cancer Center

CYam@mdanderson.org

713-792-2817

Study Officials

• Clinton Yam

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 21, 2015
• Study Start: February 4, 2016
• Primary Completion: May 23, 2025
• Study Completion: May 23, 2025
• Last Updated: February 17, 2026
• Results First Posted: February 17, 2026

Record last verified: 2026-01

Locations

US (1)