Non Metastatic HER2 Positive Breast Cancer
Conditions
Keywords
HER2 positive, Breast cancer, non metastatic, Neoadjuvant therapy, Algerian women, Subcutaneous trastuzumab-pertuzumab, pathologic complete response
Brief 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.
Interventions
None listed
Sponsors
Blida 1 University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) Rate | At the time of surgery, approximately 18-24 weeks after the start of neoadjuvant treatment. | The proportion of participants with no residual invasive cancer in the breast and axillary lymph nodes after completion of neoadjuvant therapy, defined as ypT0/Tis ypN0 according to standard pathological assessment. Pathological evaluation will be performed on surgical specimens by certified pathologists following local and international guidelines. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breast-Conserving Surgery Rate | At the time of surgery, approximately 18-24 weeks after the start of neoadjuvant treatment. | Proportion of participants undergoing breast-conserving surgery after completion of neoadjuvant therapy. Determined from surgical records. |
| Incidence of Adverse Events | From first dose of study treatment until 30 days after last dose (approximately 20-22 weeks). | Frequency and severity of treatment-related adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version in use at study initiation. |
| Patient Satisfaction With Treatment | Post-surgery (approximately 24-28 weeks after treatment initiation). | Proportion of participants reporting satisfaction with subcutaneous administration of trastuzumab-pertuzumab (Phesgo), as assessed by a study-specific satisfaction questionnaire. |
| Predictive Factors of Response | From baseline to surgery (approximately 18-24 weeks after treatment initiation). | Association between clinical, pathological, and biological characteristics (including biomarkers) and pathological complete response. |
Countries
Algeria
Outcome results
None listed