Subcutaneous trastuzumab‑pertuzumab before surgery for Algerian women with locally advanced HER2‑positive breast cancer
Official title: Evaluation of the Efficacy of Subcutaneous Trastuzumab-Pertuzumab Combination in Neoadjuvant Treatment of Non-Metastatic HER2-Positive Breast Cancer in Algerian Women
Run by Blida 1 University · NCT07166185 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 19 Years and up |
| Sex | Women only |
| Enrollment | 70 (estimated) |
| Sponsor | Blida 1 University Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, chemotherapy |
| Locations | 1 site (Blida) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | October 2025 |
| Study ends | December 2025 |
| Registry record updated | September 10, 2025 |
| Trial ID | NCT07166185 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Medical oncology department - Anti Cancer Center of Blida
Blida, Algeria Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.