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A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab and Taxane Based Therapy (KATE2)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02924883
First received: September 21, 2016
Last updated: May 29, 2017
Last verified: May 2017
  Purpose
This phase II, double-blind, randomized, placebo-controlled multicenter study will investigate the efficacy and safety of trastuzumab emtansine in combination with atezolizumab or atezolizumab-placebo in participants with HER2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab and taxane based therapy, either alone or in combination, and/or who have progressed within 6 months after completing adjuvant therapy.

Condition Intervention Phase
Metastatic Breast Cancer Drug: Atezolizumab Drug: Trastuzumab emtansine Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression Free Survival (PFS) as Determined by Investigator's Tumor Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: From Baseline until disease progression or death (up to approximately 28 months) ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: From Baseline until death or end of study (up to approximately 28 months) ]
  • Percentage of Participants With Objective Response (OR) as Determined by Investigator's Tumor Assessment Using RECIST v1.1 [ Time Frame: From Baseline until disease progression or death (up to approximately 28 months) ]
  • Duration of OR as Determined by Investigator's Tumor Assessment Using RECIST v1.1 [ Time Frame: From Baseline until disease progression or death (up to approximately 28 months) ]
  • Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 28 months ]
  • Maximum Serum Concentration of Trastuzumab Emtansine [ Time Frame: Pre-infusion(0 hour [h]),30 min after end of infusion (EOI) (over 90 min) on Day 1 of Cycle 1 and 4; pre-infusion (0 h) on Day 1 of Cycle 2(each cycle=21 days); at any time during study treatment/early discontinuation visit(up to approximately 28 months) ]
  • Serum Concentration of Total Trastuzumab [ Time Frame: Pre-infusion (0 h), 30 min after EOI (over 90 min) on Day 1 of Cycle 1 and 4; pre-infusion (0 h) on Day 1 of Cycle 2 (each cycle = 21 days) ]
  • Maximum Plasma Concentration of Deacetyl mercapto 1-oxopropyl maytansine (DM1) [ Time Frame: Pre-infusion (0 h) on Day 1 of Cycle 1 and 30 min after EOI (over 90 min) on Day 1 of Cycle 1 and 4 (each cycle = 21 days) ]
  • Maximum Serum Concentration of Atezolizumab [ Time Frame: Pre-infusion(0 h),30 min after EOI(over 60 min)on Day 1 of Cycle 1 & 4; pre-infusion(0 h)on Day 1 of Cycles 2,3,8 & every 8 cycles thereafter(each cycle=21 days)up to120 days after treatment completion/early discontinuation(up to approximately 28 months) ]
  • Percentage of Participants With Anti-therapeutic Antibodies (ATA) to Atezolizumab [ Time Frame: Pre-infusion (0 h) on Day 1 of Cycles 1, 2, 3, 4, 8 & every 8 cycles thereafter (each cycle=21 days) up to 120 days after treatment completion or early discontinuation (up to approximately 28 months) ]
  • Percentage of Participants With ATA to Trastuzumab Emtansine [ Time Frame: Pre-infusion (0 h) on Day 1 of Cycle 1 and 4 (each cycle = 21 days); and at any time during study treatment/early discontinuation visit (up to approximately 28 months) ]

Estimated Enrollment: 200
Actual Study Start Date: September 26, 2016
Estimated Study Completion Date: June 4, 2019
Estimated Primary Completion Date: April 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trastuzumab Emtansine + Atezolizumab
Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 of Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to approximately 28 months)
Drug: Atezolizumab
Atezolizumab 1200 mg IV infusion
Other Name: RO5541267, MPDL3280A
Drug: Trastuzumab emtansine
Trastuzumab emtansine 3.6 mg/kg IV infusion
Other Name: Kadcyla®, T-DM1, RO5304020
Active Comparator: Trastuzumab Emtansine + Placebo
Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 of Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to approximately 28 months)
Drug: Trastuzumab emtansine
Trastuzumab emtansine 3.6 mg/kg IV infusion
Other Name: Kadcyla®, T-DM1, RO5304020
Other: Placebo
Placebo matched to atezolizumab

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Archival tumor samples must be obtained from primary and/or metastatic sites
  • Able to submit tumor tissue that is evaluable for programmed death- ligand 1 (PD-L1) expression
  • HER-2 positive breast cancer (BC) as defined by an immunohistochemistry (IHC) score of 3 or gene amplified by in-situ hybridization (ISH) as defined by a ratio of greater than or equal to (>/=) 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies
  • Histologically or cytologically confirmed invasive BC: incurable, unresectable, locally advanced BC previously treated with multimodality therapy or metastatic breast cancer (MBC)
  • Prior treatment for BC in the: adjuvant; unresectable locally advanced; or metastatic settings; which must include both, a taxane and trastuzumab (alone or in combination with another agent)
  • Progression must have occurred during or after most recent treatment for locally advanced BC/MBC or within 6 months after completing adjuvant therapy
  • Participants must have measurable disease that is evaluable as per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Negative serum pregnancy test for pre-menopausal women and for women less than 12 months after the onset of menopause
  • Use of highly effective method of contraception as defined by the protocol

Exclusion Criteria:

  • Prior treatment with trastuzumab emtansine, cluster of differentiation 137 (CD137) agonists, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
  • Receipt of any anti-cancer drug/biologic or investigational treatment within 28 days prior to randomization except hormone therapy, which can be given up to 7 days prior to randomization; recovery of treatment related toxicity consistent with other eligibility criteria
  • Radiation therapy within 2 weeks prior to Cycle 1, Day 1
  • History of exposure to the cumulative doses of anthracyclines
  • History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or participants who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrence
  • Cardiopulmonary dysfunction, symptomatic pleural effusion, pericardial effusion, or ascites
  • Current severe, uncontrolled systemic disease
  • Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
  • Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, autoimmune hepatic disorders, sclerosis cholangitis or active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
  • Need for current chronic corticosteroid therapy (>/=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)
  • 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 greater than (>) 2 weeks prior to randomization
  • Participants with known central nervous system disease
  • History of autoimmume disease
  • Prior allogeneic stem cell or solid organ transplantation
  • Active tuberculosis
  • Receipt of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live, attenuated vaccine will be required during the study
  • Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug (whichever is shorter) prior to randomization
  • Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02924883

Contacts
Contact: Reference Study ID Number: WO30085 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Show 90 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02924883     History of Changes
Other Study ID Numbers: WO30085
2015-004189-27 ( EudraCT Number )
Study First Received: September 21, 2016
Last Updated: May 29, 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Ado-trastuzumab emtansine
Trastuzumab
Maytansine
Antibodies, Monoclonal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017