RecruitingNCT07166185

Efficacy of Neoadjuvant Subcutaneous Trastuzumab-Pertuzumab in Algerian Women With Locally Advanced HER2 Positive Breast Cancer

Evaluation of the Efficacy of Subcutaneous Trastuzumab-Pertuzumab Combination in Neoadjuvant Treatment of Non-Metastatic HER2-Positive Breast Cancer in Algerian Women


Sponsor

Blida 1 University

Enrollment

70 participants

Start Date

Mar 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating how well a combination of two HER2-targeted drugs — trastuzumab and pertuzumab, given as injections under the skin — works before surgery in Algerian women with locally advanced HER2-positive breast cancer. HER2-positive means the cancer cells have a protein that makes them grow faster, and these drugs specifically block that protein. **You may be eligible if...** - You are a woman aged 19 or older - Your breast cancer has been confirmed by biopsy to be HER2-positive and has not spread to other organs - You are a candidate for treatment before surgery - Your heart function is normal (ejection fraction ≥50%) - You are in reasonably good health **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have had prior anti-HER2 therapy - You are pregnant or breastfeeding - You have known allergies to trastuzumab or pertuzumab - You refuse surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Medical oncology department - Anti Cancer Center of Blida

Blida, Algeria

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NCT07166185