Actively Recruiting
Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
Led by AC Camargo Cancer Center · Updated on 2021-08-06
80
Participants Needed
1
Research Sites
373 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase II unicentric randomized trial which will include early HER2 positive breast cancer patients, candidate to neoadjuvant therapy with trastuzumab and pertuzumab. Circulating tumor cells will be collected at neoadjuvant therapy baseline. Patients with pathological complete response will be randomized in 1:1 ratio for adjuvant trastuzumab (arm A) versus trastuzumab + pertuzumab (arm B) in a two factorial design: group A, with HER2 positive CTCs and group B, with HER2 negative/absent CTCs.
CONDITIONS
Official Title
Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HER2 positive breast cancer, with hormone receptors either positive or negative
- Stage I to III breast cancer
- Candidates for neoadjuvant therapy including any chemotherapy regimen plus trastuzumab and pertuzumab
- Planned breast surgery after completing neoadjuvant therapy
- Preserved cognitive function
- ECOG performance status of 0 to 3
- Pathological complete response for randomization phase (ypT0/ypTis and ypN0)
- Signed informed consent form and agreement to participate
You will not qualify if you...
- Contraindications to trastuzumab or pertuzumab
- Receiving adjuvant chemotherapy (hormone therapy allowed)
- Second primary cancer diagnosed within the past 5 years, except for treated non-melanoma skin cancer or in situ cervical cancer
AI-Screening
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Trial Site Locations
Total: 1 location
1
A.C. Camargo Cancer Center
São Paulo, Brazil, 01525-001
Actively Recruiting
Research Team
M
Marcelle G Cesca, MD
CONTACT
L
Ludmilla TD Chinen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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