Breast CancerTemporarily On HoldPhase 1

BREAST; METASTATIC: PHASE 1 (EXPANSION): TRIPLE NEGATIVE: PIK3CA mt: 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

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Study snapshot

Title: Genentech CO40115 (MORPHEUS-Breast)
Malignancy: Breast, Triple Negative Breast Cancer, TNBC
Stage: Stage 4
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
Principal investigator: Greg Vidal, MD, PhD
Sponsor: Hoffman-La Roche
Intervention arm: Multiple arms
Path: ER- (negative), PR- (negative), HER2- (negative)
Randomized: Yes
ClinicalTrials.gov ID: NCT03424005

Eligibility and objectives

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

Study snapshot

Eligibility and objectives

Key eligibility criteria details

Objective

Treatment details