A trial of MPDL3280A and nab-Paclitaxel in metastatic triple negative breast cancer

Phase 1

• Conditions: Previously untreated metastatic triple negative breast cancer; MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005490-37-FI
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-04
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 350

Inclusion Criteria

• Women aged = 18 years
• Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
• No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
• Representative FFPE tumor specimens in paraffin blocks (preferred) or at least
15 unstained slides, with an associated pathology report documenting ER, PR, and HER2 negativity
•A tumor specimen obtained from metastatic or locally advanced disease (if applicable) must be submitted if clinically feasible
• ECOG performance status of 0 or 1
• Life expectancy = 12 weeks
• Measurable disease, as defined by RECIST v1.1
•Adequate hematologic and end-organ function defined by laboratory results obtained within 2 weeks prior to first study treatment.
•Women of child bearing potential must agree to use adequate contraception (double barrier
methods of birth control or abstinence) prior to study entry, for the duration of study treatment, and for at least 5 months after the last dose of study treatment.
• Patients who are not postmenopausal (= 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 228
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 122

Exclusion Criteria

• Spinal cord compression not definitively treated with surgery and/or radiation, or previously
diagnosed and treated spinal cord compression without evidence that disease has been
clinically stable for > 2 weeks prior to randomization
• Known CNS disease, except for treated asymptomatic CNS metastases
• Leptomeningeal disease
• Uncontrolled pleural effusion, pericardial effusion, or ascites (indwelling drainage catheters are permitted)
• Uncontrolled tumor-related pain
• Uncontrolled hypercalcemia
•Pregnancy or lactation
• Evidence of significant uncontrolled concomitant disease that could affect compliance with
the protocol or interpretation of results, including significant liver disease (such as cirrhosis,
uncontrolled major seizure disorder, or superior vena cava syndrome)
• Significant cardiovascular disease
• Severe infection within 4 weeks prior to randomization, including but not limited to
hospitalization for complications of infection, bacteremia, or severe pneumonia
• History of autoimmune disease (Autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and Type 1 diabetes mellitus on an stable insulin regimen may be eligible for this study)
• 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 CT scan.
History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Positive test for HIV
• Active hepatitis B or hepatitis C
•Active tuberculosis
•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) within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial.
Low dose steroids for nausea, adrenocortical insufficiency or orthostatic hypotension, IV contrast allergic reactions and inhaled corticosteroids are permitted.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified