Status:
ACTIVE_NOT_RECRUITING
Study With Atezolizumab in Combination With Trastuzumab and Vinorelbine in HER2-positive Advanced/Metastatic Breast Cancer
Lead Sponsor:
SOLTI Breast Cancer Research Group
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Immune checkpoint inhibitors given in monotherapy in advanced breast cancer have shown modest benefit in first-line, but very limited efficacy in later lines. Thus, combination therapies are needed. ...
Eligibility Criteria
Inclusion
- Male or female (Premenopausal or postmenopausal women)
- ECOG 0 to 2
- Histologically confirmed adenocarcinoma of the breast, metastatic or unresectable locally advanced.
- All patients must have received at least trastuzumab and other anti-HER2 ADCs (including but not limited to T-DM1).
- Measurable disease according to RECIST 1.1 criteria.
- Adequate organ function
- Baseline LVEF ≥50%
- Participants with asymptomatic brain metastases are eligible.
Exclusion
- Treatment with any investigational anticancer drug within 14 days of the start of study treatment.
- Patient has received Vinorelbine or any other vinca alkaloids previously immediately prior to initiate study treatment.
- History of other malignant tumors in the past 3 years
- Known or suspected leptomeningeal disease (LMD)/ poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases.
- Symptomatic hypercalcemia requiring treatment with bisphosphonates in the 14 days prior to inclusion
- Cardiopulmonary dysfunction
- Any other severe, uncontrolled
- Major surgery in the 28 days prior to enrolment
- Infection with HIV or active Hepatitis B and/or Hepatitis C.
- History of trastuzumab intolerance, including grade 3-4 infusion reaction or hypersensitivity.
- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
- History of autoimmune disease,
- Prior allogeneic stem cell or solid organ transplantation
- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan. (Note: History of radiation pneumonitis in the radiation field \[fibrosis\] is permitted.)
- Active tuberculosis
- Receipt of a live, attenuated vaccine within 4 weeks prior to enrollment
- Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1 therapeutic antibody or immune checkpoint targeting agents
- Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin \[IL\]-2) within 4 weeks or five half-lives of the drug prior to enrolment
- Treatment with systemic immunosuppressive medications within 2 weeks prior to enrolment, or anticipated requirement for systemic immunosuppressive medications during the trial.
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04759248
Start Date
March 15 2021
End Date
July 1 2027
Last Update
September 9 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
H. Clínico San Cecilio de Granada
Granada, Andalusia, Spain
2
Hospital del Mar
Barcelona, Barcelona, Spain, 08003
3
Institut Català d'Oncologia Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
4
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain, 38320