Subcutaneous trastuzumab‑pertuzumab before surgery for 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
This research will test whether giving the combined subcutaneous medicine Phesgo before surgery helps Algerian women with non‑metastatic HER2‑positive breast cancer clear invasive tumor from the breast and nearby lymph nodes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 19 Years and up |
| Sex | Female |
| Sponsor | Blida 1 University Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, chemotherapy |
| Locations | 1 site (Blida) |
| Trial ID | NCT07166185 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, observational real‑world study conducted at three oncology centers in Algeria that will follow about 70 adult women with non‑metastatic HER2‑positive breast cancer. Participants receive the fixed‑dose subcutaneous combination of trastuzumab and pertuzumab (Phesgo) together with standard chemotherapy for roughly 18 weeks, followed by surgical removal of the tumor. The main outcome is pathological complete response (pCR) in the breast and axillary lymph nodes; secondary outcomes include rate of breast conservation, safety and tolerability, quality of life, patient satisfaction, and biomarkers or factors that predict response. Results aim to describe how well the subcutaneous regimen works and how feasible and acceptable it is in routine oncology practice in Algeria.
Who should consider this trial
Good fit: Adult women (age ≥19) with histologically confirmed non‑metastatic HER2‑positive breast cancer who are candidates for neoadjuvant therapy, have ECOG ≤2, LVEF ≥50%, and can give informed consent are ideal candidates.
Not a fit: Patients with distant metastases, prior anti‑HER2 therapy, known contraindications to trastuzumab or pertuzumab, pregnant or breastfeeding women, or those who refuse surgery are unlikely to benefit from this neoadjuvant regimen.
Why it matters
Potential benefit: If successful, this approach could simplify HER2 therapy delivery and may increase the chance of complete tumor eradication before surgery while improving patient convenience.
How similar studies have performed: Intravenous trastuzumab plus pertuzumab has previously increased pCR rates in neoadjuvant settings, and prior trials of the subcutaneous fixed‑dose formulation have shown comparable drug exposure and improved convenience, so this approach builds on existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Blida
- Medical oncology department - Anti Cancer Center of Blida — Blida, Algeria (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.