Efficacy of Neoadjuvant Subcutaneous Trastuzumab-Pertuzumab in Algerian Women With Locally Advanced HER2 Positive Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Non Metastatic HER2 Positive Breast Cancer. Basic parameters: from 19 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Algeria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of the Efficacy of Subcutaneous Trastuzumab-Pertuzumab Combination in Neoadjuvant Treatment of Non-Metastatic HER2-Positive Breast Cancer in Algerian Women
Overview
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.
Primary outcome measures
- Pathological Complete Response (pCR) Rate [Time frame: At the time of surgery, approximately 18-24 weeks after the start of neoadjuvant treatment.]
Secondary outcome measures (4)
- Breast-Conserving Surgery Rate [Time frame: At the time of surgery, approximately 18-24 weeks after the start of neoadjuvant treatment.]
- Incidence of Adverse Events [Time frame: From first dose of study treatment until 30 days after last dose (approximately 20-22 weeks).]
- Patient Satisfaction With Treatment [Time frame: Post-surgery (approximately 24-28 weeks after treatment initiation).]
- Predictive Factors of Response [Time frame: From baseline to surgery (approximately 18-24 weeks after treatment initiation).]
Eligibility criteria
Inclusion criteria
- Female participants aged 19 years or older.
- Histologically confirmed HER2-positive breast cancer (by immunohistochemistry and/or in situ hybridization), non-metastatic.
- Candidate for neoadjuvant therapy according to local clinical practice.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- Signed written informed consent.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Algeria · 1 center
- Medical oncology department - Anti Cancer Center of Blida — Blida
Identifiers
NCT: NCT07166185 · LRC 01.002