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BREAST; METASTATIC: PHASE 1 (EXPANSION): TRIPLE NEGATIVE: 1st Line: MORPHEUS

A Phase 1b/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer

Title
Genentech CO40115 (MORPHEUS-Breast)
Study Title

A Phase 1b/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer

Site Link
Malignancy
Breast, Triple Negative Breast Cancer, TNBC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd Line
Investigational Agent
Atezolizumab with Ipatasertib or ladiratuzumab-vidotin or Bevacizumab or Cobimetinib or Capecitabine or Combination Chemo
Drug Class
PD-L1 antibody with either PI3Ki or LIV1A ADC or MEKi or VEGFRi or chemo
PI
Greg Vidal, MD, PhD
Sponsor
Hoffman-La Roche
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Triple negative metastatic breast cancer
  • 2nd line
  • ECOG PS 0-2
  • No prior treatment with any study agents
  • No history of autoimmune disease
  • Presence of measurable disease
  • No symptomatic or untreated CNS disease
Objective

Primary- ORR; Secondary- PFS, DCR, OS, DoR, safety, PK

Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
ER- (negative), PR- (negative), HER2- (negative)
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X