Actively Recruiting
Efficacy of Neoadjuvant Subcutaneous Trastuzumab-Pertuzumab in Algerian Women With Locally Advanced HER2 Positive Breast Cancer
Led by Blida 1 University · Updated on 2025-09-10
70
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to find out how effective and well-tolerated the subcutaneous form of trastuzumab-pertuzumab (known as Phesgo) is when given before surgery (neoadjuvant treatment) to Algerian women with early stage, HER2-positive breast cancer. The study will take place in three oncology centers in Algeria (Blida, Aïn Defla, Médéa) and include around 70 adult women diagnosed with non-metastatic HER2-positive breast cancer. Participants will receive Phesgo along with standard chemotherapy over about 18 weeks, followed by surgery. The main goal is to measure how many women achieve complete destruction of invasive cancer in the breast and nearby lymph nodes (pathological complete response, pCR). We will also look at other outcomes such as how many women can keep their breast, any side effects, quality of life, satisfaction with treatment, and factors that might predict response. Results from this real-world study will help assess whether Phesgo can simplify treatment delivery, reduce hospital burden, and improve care access in Algeria where healthcare resources are often stretched.
CONDITIONS
Official Title
Efficacy of Neoadjuvant Subcutaneous Trastuzumab-Pertuzumab in Algerian Women With Locally Advanced HER2 Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 19 years or older
- Histologically confirmed HER2-positive breast cancer, non-metastatic
- Candidate for neoadjuvant therapy according to local clinical practice
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
- Left ventricular ejection fraction of 50% or higher
- Signed written informed consent
You will not qualify if you...
- Evidence of distant metastases
- Prior anti-HER2 therapy
- Known contraindications to trastuzumab or pertuzumab
- Pregnancy or breastfeeding
- Disease progression during neoadjuvant treatment if already started
- Refusal of surgery
- Withdrawal of consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical oncology department - Anti Cancer Center of Blida
Blida, Algeria, 09000
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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