Actively Recruiting
Induction Therapy of PTX+BV Followed by Atezolizumab+Nab-PTX for PD-L1+ TNBC
Led by Japan Breast Cancer Research Group · Updated on 2025-01-30
106
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
Sponsors
J
Japan Breast Cancer Research Group
Lead Sponsor
C
Chugai Pharmaceutical
Collaborating Sponsor
AI-Summary
What this Trial Is About
The objective of this research is to evaluate the efficacy of the treatment strategy to administer atezolizumab + nab-paclitaxel (PTX) following 2 cycles of induction therapy with PTX + bevacizumab (induction treatment strategy) in programmed cell death ligand-1 (PD-L1)-positive metastatic triple-negative breast cancer (mTNBC) in comparison with the standard atezolizumab + nab-PTX therapy.
CONDITIONS
Official Title
Induction Therapy of PTX+BV Followed by Atezolizumab+Nab-PTX for PD-L1+ TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with metastatic recurrent or unresectable advanced triple-negative breast cancer (TNBC)
- Confirmed PD-L1 positivity (SP142 immune cell score 2 1) by recent or archival tumor sample
- For candidates of curative treatment, at least 6 months since last curative treatment to recurrence
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
- Female or male aged 18 years or older
- Histologically or cytologically confirmed TNBC that is estrogen receptor-negative (<10% positive cells or Allred score 0-2) and HER2-negative
- No prior chemotherapy for metastatic or unresectable advanced cancer (prior PARP inhibitor allowed for BRCA variant patients)
- Measurable or non-measurable lesions by CT or MRI; lesions in previously irradiated areas must show clear progression
- Laboratory values within 14 days before enrollment meet criteria for neutrophils, platelets, hemoglobin, liver enzymes, bilirubin, creatinine, and urine protein
- Blood pressure controlled with no more than two antihypertensive drugs
- Expected survival of at least 3 months
- Written informed consent obtained
- Women of childbearing potential and men with partners of childbearing potential agree to contraception and no breastfeeding during and after treatment as specified
You will not qualify if you...
- Active brain metastases or carcinomatous meningitis (stable previously treated brain metastases allowed)
- History of invasive malignancy within 3 years except certain cured skin or in situ cancers
- Concurrent bilateral invasive breast cancer unless both TNBC and PD-L1 positive
- Radiotherapy or other study drug treatment within 14 days prior to enrollment
- Live vaccine administration within 30 days before first study drug dose
- Systemic corticosteroids or immunosuppressants exceeding prednisone 10 mg/day within 14 days for active autoimmune disease
- Active infection requiring systemic treatment
- Interstitial lung disease or pneumonitis currently or history requiring corticosteroids
- Pregnancy, possible pregnancy, or lactation
- Positive for hepatitis B surface antigen or hepatitis C antibody (unless virus is undetectable)
- Positive for HIV-1 or HIV-2 antibodies
- Significant cardiovascular disease or recent heart events within 6 months
- Poorly controlled diabetes, significant neuropathy, bleeding disorders, recent thromboembolism, severe gastrointestinal conditions, or other serious complications
- Conditions, therapies, or lab abnormalities interfering with study participation
- Psychiatric conditions interfering with study conduct
- Hypersensitivity to study drugs or related compounds
- Alcohol intolerance or hypersensitivity to Cremophor
- History of active tuberculosis infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yukinori Ozaki
Koto-ku, 3-8-31, Tokyo, Japan, 135-8550
Actively Recruiting
Research Team
Y
Yukinori Ozaki
CONTACT
N
Norikazu Masuda
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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