Actively Recruiting
A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2024-07-22
50
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
Sponsors
G
Gustave Roussy, Cancer Campus, Grand Paris
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Choice Of the Most Active Strategies for Short term recurring Triple Negative Breast Cancer: A phase Ib/II, open-label, modular, dose-finding and dose-expansion study to explore safety, tolerability, pharmacokinetics, and anti-tumor activity of novel therapeutics in patients with early relapsed metastatic triple-negative breast cancer
CONDITIONS
Official Title
A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years or older with pathologically confirmed advanced or metastatic HER2-negative, hormone receptor-negative breast cancer
- Early relapse of triple-negative breast cancer with recurrence or metastasis during or within 12 months after neoadjuvant or adjuvant chemotherapy
- Provision of adequate tissue samples from biopsy or archival tumor tissue
- ECOG performance status of 0 to 2
- Left ventricular ejection fraction (LVEF) of 50% or higher within 28 days before enrollment
- Adequate organ and bone marrow function within 14 days prior to treatment
- At least one measurable lesion by RECIST 1.1 criteria, not previously irradiated
- Adequate treatment washout period before enrollment
- Patients with controlled brain metastases or leptomeningeal disease on corticosteroids at doses up to 10 mg/day prednisone or equivalent
- Women of child-bearing potential must have negative pregnancy tests and use effective contraception
- Male patients sexually active with female partners of child-bearing potential must use condom with spermicide and agree to contraception requirements
- Patients must understand and sign informed consent and be able to comply with study procedures
- Patients must be affiliated with a social security system or beneficiary of the same
You will not qualify if you...
- Untreated spinal cord compression or brain/leptomeningeal metastases requiring more than 10 mg/day prednisone or equivalent
- Uncontrolled infections, significant cardiovascular or lung disease, severe gastrointestinal conditions, or psychiatric illness impairing compliance
- Clinically significant corneal disease
- History or current interstitial lung disease or pneumonitis requiring steroids
- Active autoimmune or connective tissue diseases requiring treatment within the past 5 years, except certain stable conditions
- Active primary immunodeficiency
- Active or uncontrolled hepatitis B or C virus infection not meeting specific criteria
- Uncontrolled HIV infection
- Concurrent systemic cancer therapy, radiotherapy, investigational agents, or biological therapy
- History of other primary malignancy within 5 years except certain treated cancers
- History of severe hypersensitivity reactions to study treatments or similar monoclonal antibodies
- Prior treatment with antibody-drug conjugates targeting TROP2
- History of allogeneic organ transplantation
- Clinically significant uncontrolled heart disease or recent cardiac events
- Use of immunosuppressive medications within 14 days prior to first study drug dose
- Pregnancy or breastfeeding, or unwillingness to use effective birth control
- Recent live attenuated vaccine administration within 30 days before study treatment
- Legal or social situations preventing compliance with study requirements
- Participation in another clinical trial with investigational product within 4 weeks prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
T
Thomas Grinda, MD
CONTACT
C
Chloé Serhal, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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