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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (pCR) Rate | 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. | At the time of surgery, approximately 18-24 weeks after the start of neoadjuvant treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Breast-Conserving Surgery Rate | Proportion of participants undergoing breast-conserving surgery after completion of neoadjuvant therapy. Determined from surgical records. | At the time of surgery, approximately 18-24 weeks after the start of neoadjuvant treatment. |
| Incidence of Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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Adult female patients diagnosed with HER2-positive, non-metastatic breast cancer and eligible for neoadjuvant therapy according to local clinical practice in Algeria. Participants will be recruited from three oncology centers: Anti Cancer Center of Blida, public hospital of Aïn Defla, and public hospital of Médéa.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical oncology department - Anti Cancer Center of Blida | Recruiting | Blida | 09000 | Algeria |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000095384 | Pathologic Complete Response |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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. |
| From first dose of study treatment until 30 days after last dose (approximately 20-22 weeks). |
| Patient Satisfaction With Treatment | Proportion of participants reporting satisfaction with subcutaneous administration of trastuzumab-pertuzumab (Phesgo), as assessed by a study-specific satisfaction questionnaire. | Post-surgery (approximately 24-28 weeks after treatment initiation). |
| Predictive Factors of Response | Association between clinical, pathological, and biological characteristics (including biomarkers) and pathological complete response. | From baseline to surgery (approximately 18-24 weeks after treatment initiation). |
| D017437 |
| Skin and Connective Tissue Diseases |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |